# Men's Hair Loss > Hair Loss Treatments > Cutting Edge / Future Treatments >  Sm04554

## UK Boy

There is record of a clinial trial being carried out on the Australia New Zealand Clinical Trials Registry. It is for a topical solution containing a small molecule currently named SM04554. The trial states that this topical may activate the wnt pathway. Trial was only short and started Sept 2013. I wonder what the outcomes were. There is a contact for public enquiries if someone has time to send them an email - it's on the trial details.

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## hellouser

Link to source?

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## bigentries

It's still recruiting 
https://www.anzctr.org.au/Trial/Regi...aspx?id=364645

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## deuce

Sounds cool, but is Australia's drug approval process as messed up as the US?.  I do not know about yall but I cannot wait much longer for a safe topical AA.  Hassan and Wong talked about a topical AA that is suppose to be out this year, but cannot remember the name to it.  C'mon man how can you say something like that and get our hopes up.  I do not think it is CB because they heard it at a hair loss convention and Cosmo did not deliver any addresses that said it would be out this year.

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## bigentries

> Sounds cool, but is Australia's drug approval process as messed up as the US?.  I do not know about yall but I cannot wait much longer for a safe topical AA.  Hassan and Wong talked about a topical AA that is suppose to be out this year, but cannot remember the name to it.  C'mon man how can you say something like that and get our hopes up.  I do not think it is CB because they heard it at a hair loss convention and Cosmo did not deliver any addresses that said it would be out this year.


 From the looks of that page, there is recruiting happening in the US at this moment

The Hasson & Wong things ended up being a misunderstanding

And for God's sake, stop with the FDA bitching, save it for a time when a drugs advances to phase III with decent results

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## deuce

Wow so this did not go through any trials yet?  Would have been good news about ten years ago, but unfortunately most of us will be bald by the time this comes out.  I was not bitching about the FDA just saying it is messed up.  As far as H and W.  How do you know it was a misunderstanding.  Did they say that?  Where and when?

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## bigentries

> Wow so this did not go through any trials yet?  Would have been good news about ten years ago, but unfortunately most of us will be bald by the time this comes out.  I was not bitching about the FDA just saying it is messed up.  As far as H and W.  How do you know it was a misunderstanding.  Did they say that?  Where and when?


 http://www.baldtruthtalk.com/showthread.php?t=15018




> I asked Dr. Hasson about this a few days ago. He said that there was nothing more to share than what has already been stated. He doesn't know the name of this AA and he heard about it at the ISHRS conference back in October.


 Seems like the general consensus is that it was a misunderstanding.

As far as the clinical trial goes, the status says that it is recruiting, but they expected to end enrollment by November last year, so maybe they haven't updated

*My bad, it doesn't seem to be any recruitment in the US at the moment*, I misinterpreted the "Page 8" and "recruitment outside australia" sections. But it does lists a company in America as the primary sponsor

Still, this stuff seems pretty interesting, the primary sponsor seems connected with WNT research
http://www.samumed.com/

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## lilpauly

> From the looks of that page, there is recruiting happening in the US at this moment
> 
> The Hasson & Wong things ended up being a misunderstanding
> 
> And for God's sake, stop with the FDA bitching, save it for a time when a drugs advances to phase III with decent results


 I agree phase 111 is crucial , most go dead after phase 1 .

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## hellouser

> I agree phase 111 is crucial , most go dead after phase 1 .


 Many go dead after Phase I too *cough*Aderans,RU58841,neosh,etc*cough*

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## Jens1986

> Many go dead after Phase I too *cough*Aderans,RU58841,neosh,etc*cough*


 PSK 3841, a nonsteroidal
antiandrogen, has completed phase IIa
trials for the treatment of androgenetic
alopecia and a clinical proof-of-concept
study to reduce sebum flow and
secretion in patients with acne. Six
months of treatment with PSK 3481
demonstrated equivalent or better net
hair growth compared with finasteride.

Source: «Drug News» Vol. 13, No. 13 March 2004

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## Desmond84

> PSK 3841, a nonsteroidal
> antiandrogen, has completed phase IIa
> trials for the treatment of androgenetic
> alopecia and a clinical proof-of-concept
> study to reduce sebum flow and
> secretion in patients with acne. Six
> months of treatment with PSK 3481
> demonstrated equivalent or better net
> hair growth compared with finasteride.
> ...


 Wow 2004! How depressing :'( All our problems would have been solved if this came out...sigh

Let's just hope we don't add Histogen to this list. They've now been silent for 15 months after completion of Phase 2a

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## huawei

Interesting, its a shame I'm only a nw 2/3 otherwise I would apply as I am close to the area. 

Isn't Desmond from Australia or the oceanic region? Or was another forum regular

Edit: Here's another one...RK-023. There is not much info on it but its currently being trialed on eye lashes with the intended effect to turn velus hairs into something more so it seems.

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## Atum

> Interesting, its a shame I'm only a nw 2/3 otherwise I would apply as I am close to the area. 
> 
> Isn't Desmond from Australia or the oceanic region? Or was another forum regular
> 
> Edit: Here's another one...RK-023. There is not much info on it but its currently being trialed on eye lashes with the intended effect to turn velus hairs into something more so it seems.


 Seems phase IIa was complete in januari 2011:



> The completion of the Phase 2a clinical study of RK-023 for the treatment of androgenetic alopecia has been announced in January 24th, 2011.


 http://www.businesswire.com/news/hom...3#.UvuptfldW1s

Although it seems they made a new formula of Rk-023, as they started Phase I in February 2011.

Don't know why, but it's automatically changed to dutch. 
http://www.news-medical.net/news/201...096/Dutch.aspx

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## Jens1986

> Wow 2004! How depressing :'( All our problems would have been solved if this came out...sigh
> 
> Let's just hope we don't add Histogen to this list. They've now been silent for 15 months after completion of Phase 2a


 
PSK 3841 = RU 58841, got renamed after Roussel Uclaf sold it to ProStrakan.

It was just to show hellouser that RU made it past Phase I

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## hellouser

> PSK 3841 = RU 58841, got renamed after Roussel Uclaf sold it to ProStrakan.
> 
> It was just to show hellouser that RU made it past Phase I


 It still got shelved in the end. Nothing to be happy about.

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## Jens1986

> It still got shelved in the end. Nothing to be happy about.


 You are always so negative. It got shelved cus its not stable enough and/or they didnt think it was good enough for production, fin was allready on the marked and its easier to just take a pill. Its easy to get RU, and if it wasnt for Roussel Uclaf/ProStrakan we would not have RU as an option. Researhers/scientists are helping a lot of us, stop complaining about everything pls it just makes u look like a whiner. "omgomgomg if we were women this would have been fixed a long time ago, the world dont give a shit about men"

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## thinning44

Phase 2 for Samumed SM04554 now posted on clinicaltrials.gov. Multiple US sites listed, not yet recruiting, androgenetic alopecia.

http://www.clinicaltrials.gov/ct2/show/NCT02275351

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## Swooping

> Phase 2 for Samumed SM04554 now posted on clinicaltrials.gov. Multiple US sites listed, not yet recruiting, androgenetic alopecia.
> 
> http://www.clinicaltrials.gov/ct2/show/NCT02275351


 I'm very curious. We know the WNT/b-catenin pathway plays a immense role in hairloss. Hopefully this direct agonist of the WNT pathway will do a better job than minox for example as a growth agent.

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## hgs1989

> I'm very curious. We know the WNT/b-catenin pathway plays a immense role in hairloss. Hopefully this direct agonist of the WNT pathway will do a better job than minox for example as a growth agent.


 it also play a role in the adipose cells differentiation: http://www.pnas.org/content/111/15/E1501.abstract

and we know that the fatty tissue ;required also for hair growth; on our scalps is thinning as we lose our hair.

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## Boldy

If i'm correct : wnt agonist works the same way as wnt's, they need the LRP5/6 + frizzled receptor to phosphorylze GSK3b, so that B-cetanin can be trans located to the nuclies, and genes such as tcf(important for hair growth), can be activated.

Now in aga we many inhibitors one of the is DKK1 which block the above mentioned receptor where wnt does its work. GSk3b inhibitors like vpa or more selective 6BIO , don't need the frizzeled + lrp5-6 receptors, it enters the cell, and immediately starts gsk3b phosphorylation of GSK3 that leads to b-cetanin accumulation and translocation to the nuclies(what we need). so it is a shortcut and it overrules the inhibitory effect of dkk1. it is why i believe that gsk3b inhibitors have more potential in vivo.

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## hellouser

> If i stand correct: wnt agonist works the same way as wnt's, they need the LRP5/6 + frizzled receptor to phosphorylze GSK3b, so that B-cetanin can be trans located to the nuclies, and genes such as tcf(important for hair growth), can be activated.
> 
> now in aga we many inhibitors one of the is DKK1 which block the above mentioned receptor where wnt does its work. GSk3b inhibitors like vpa or more selective 6BIO , don't need the frizzeled + lrp5-6 receptors, it enters the cell, and immediately starts gsk3b phosphorylation of GSK3 that leads to b-cetanin accumulation and translocation to the nuclies(what we need). so it is a shortcut and it overrules the inhibitory effect of dkk1. it is why i believe that gsk3b inhibitors have more potential in vivo.


 Block DKK1 anyway along with DHT. I doubt full regrowth is possible but should be good for SOME reversal and at least long term maintenance.

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## KO1

Guys they will start having Phase 2 clinical trials. Let's get the word out so members of the community can participate. Maybe Spencer Kobren can look into giving this publicity.

http://www.clinicaltrials.gov/ct2/sh...75351#contacts


Remember, you cannot be on any HL meds if you want to be part of the trial.  :Smile:

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## Swooping

When will those clinical trials start? Would be great if someone from the board will sign up to it  :Smile: .

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## Gjm127

This is great news! So now we have CB and SM in phase 2 trials. Replicel and Histogen still going at it. Good things on the way guys! 

Hopefully SM keeps us up to date with the trials.

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## KO1

Study is starting next month! Move fast!

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## inbrugge

any promising results from their phase 1?

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## KO1

Not much interest for this huh. Odd, given all the hate finasteride gets on this forum.

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## Tenma

> Not much interest for this huh. Odd, given all the hate finasteride gets on this forum.


 I was thinking the same. This stuff seems to be our only chance to have a more than decent regrowth agent in the coming years. 

Also the Phase II trial is recruiting 300 participants, which shows how well funded they are. 

I recall reading somewhere they had some sort of agreement with Pfizer.

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## hellouser

What's the agent/chemical thats the WNT agonist???

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## rdawg

> any promising results from their phase 1?


 +1, where are the phase I results?

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## KO1

PHase I was just safety, they're unlikely to release efficacy data....if they even gave it enough time to work.

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## paulneedshair

looks good

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## macbeth81

> PHase I was just safety, they're unlikely to release efficacy data....if they even gave it enough time to work.


 Anyone notice how they used a higher dosage during Phase I safety trials? Phase I used 0.05%, 0.15%, and *0.45%*, while Phase II is using only  0.15% and 0.25%. Would there be safety issues regarding manipulating WNT pathways? 

The only other explanation is that they found 0.45% unnecessary and are narrowing down to the most efficient dosage. 

Doesn't this work similar to Histogen?

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## LMS

> Doesn't this work similar to Histogen?


 Kind of but not really. Histogen is growth factors which activate numerous pathways of which the WNT pathways is one of them.  This drug merely activates the WNT pathway if I am correct.  So different MoAs above all.

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## KO1

I think they just wanted to overdose just to check the tolerable range. But there are definitely safety issues with Wnt - it is an important signal in cancer growth.

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## hgs1989

regarding cancer, from my understanding is that wnt cause proliferation of cells and over expressed in caner cells which provide cancer the ability to spread and proliferate fast. in addition wnt is also required for certain type of carcinogenesis. the over proliferation of cells can lead to mutation that causes cancer. this is why wnt is effective in hair regeneration because it causes cells differentiation and proliferation.

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## The Alchemist

> Anyone notice how they used a higher dosage during Phase I safety trials? Phase I used 0.05%, 0.15%, and *0.45%*, while Phase II is using only  0.15% and 0.25%. Would there be safety issues regarding manipulating WNT pathways? 
> 
> The only other explanation is that they found 0.45% unnecessary and are narrowing down to the most efficient dosage. 
> 
> Doesn't this work similar to Histogen?


 Phase I trials are done to assess the safety of the treatment.  They are done at doses higher than what would be administered in the final commercial product.  You have to be able to define the toxicity, or lack there of, at the dosage levels intended to be used in the general public.  The only way to do this is by exceeding the therapeutic dose and seeing if there is toxicity.   If the safety profile is clean at a higher dose, they can proceed with future trials with little concern that lower doses would be toxic.

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## Shinobi

Im wondering by wich mecanism this molecule works. What is the target ? We already have study on hair promoting effect for VPA as gsk3 inhibitor which then increase b catenin in nucleus (proteasome inhibitors also upregulate beta-catenin levels). We also have other good candidate for such purpose like 6-bio wich is a potent, reversible and ATP-competitive gsk3a/β inhibitor. This molecule is used in cell culture to maintain the properties of DP cells intact.

Such molecules are by defintion anti cells proliferation activity so scientific use growth factor such as FGF2 in the media. 

There is a lot of question awaiting for an answer for this molecule. I would like more information about it

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## KO1

> Im wondering by wich mecanism this molecule works. What is the target ? We already have study on hair promoting effect for VPA as gsk3 inhibitor which then increase b catenin in nucleus (proteasome inhibitors also upregulate beta-catenin levels). We also have other good candidate for such purpose like 6-bio wich is a potent, reversible and ATP-competitive gsk3a/β inhibitor. This molecule is used in cell culture to maintain the properties of DP cells intact.


 They have not released the mechanism by which it works, it might be a GSK-3b modulator, in which case I expect it to be more potent than VPA or 6BIO. This is a Pfizer molecule which the firm found in their chemical library and have the rights to.




> Such molecules are by defintion anti cells proliferation activity so scientific use growth factor such as FGF2 in the media.


 This is not correct, it will promote cell proliferation.

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## Swooping

I hope we can get some more information about this trial, hopefully we will get updated through the 2nd trial so we will know the effectiveness. Somebody should sign up from the forum that would be awesome. I hope it will be more selective and better acting than something like VPA, that would be awesome.

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## Boldy

> They have not released the mechanism by which it works, it might be a GSK-3b modulator, in which case I expect it to be more potent than VPA or 6BIO. This is a Pfizer molecule which the firm found in their chemical library and have the rights to.
> 
> 
> 
> This is not correct, it will promote cell proliferation.


 normal gsk3b inhibitors slowdown fibroblast proliferation (in vpa and bio studies)

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## KO1

But don't they promote proliferation of TA cells?

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## KO1

> I hope we can get some more information about this trial, hopefully we will get updated through the 2nd trial so we will know the effectiveness. Somebody should sign up from the forum that would be awesome. I hope it will be more selective and better acting than something like VPA, that would be awesome.


 Yep, we need to get the word out....all the guys who don't take any meds for hair loss can sign up for this....maybe Spencer Kobren can promote this?

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## deuce

Sucks because a lot of us will be NW5-6 by the time this comes out.Wish I was born 5 years earlier.

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## Boldy

> Yep, we need to get the word out....all the guys who don't take any meds for hair loss can sign up for this....maybe Spencer Kobren can promote this?


 

im not sure, i will read the latest study tomorrow , a vary interesting one, it is at least partly responsible for differentiation: https://www.dropbox.com/s/0716ky9q3r...Genes.pdf?dl=0

but it doesn't matter, the vpa/bio studies show slowed down fibroblast proliferation in vitro (where you want to expand as much as possible), vivo is different story anyway  :Smile:

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## hairgrowth

[QUOTE=KO1;188604]They have not released the mechanism by which it works, it might be a GSK-3b modulator, in which case I expect it to be more potent than VPA or 6BIO. This is a Pfizer molecule which the firm found in their chemical library and have the rights to.

How do you know?

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## macbeth81

They have a patent using b-diketones, y-diketones, and y-hydroxyketones to activate WNT/beta-catenin signaling. It is the only patent I found mentioning the treatment of hair loss.

http://www.faqs.org/patents/app/20140005228

Someone posted a comment on an article stating it did not meet its efficacy goals. Obviously not proof, just the rumour mill. I don't see how they would see much efficacy after 28 days using the compound for only 2 weeks.

http://www.ipscell.com/2014/10/stem-...#comment-29509

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## ryan82

> Many go dead after Phase I too *cough*Aderans,RU58841,neosh,etc*cough*


 do you know why RU58841 dies in phase 1 ?

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## sdsurfin

> They have a patent using b-diketones, y-diketones, and y-hydroxyketones to activate WNT/beta-catenin signaling. It is the only patent I found mentioning the treatment of hair loss.
> 
> http://www.faqs.org/patents/app/20140005228
> 
> Someone posted a comment on an article stating it did not meet its efficacy goals. Obviously not proof, just the rumour mill. I don't see how they would see much efficacy after 28 days using the compound for only 2 weeks.
> 
> http://www.ipscell.com/2014/10/stem-...#comment-29509


 hmmm that sucks.  if you read the trial data though they were not really testing in any real way for efficacy. was just a safety trial with questions asked to the patients. whoever posted that comment could have misunderstood.   I think this actually sounds much more promising than CB. has big money behind it and tons of test locations for phase 2. good to see some research being applied, and i think in the near future a combo of something like this with an anti androgen could be really great.  just goes to show these things can come out of the blue.

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## KO1

https://www.anzctr.org.au/Trial/Regi...aspx?id=364645

They applied the drug for 14 days, and measured hair growth on Day 28, 14 days after completion of treatment. Hard to see growth in 28 days IMHO.

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## Tenma

Also in phase I they only recruited higher Nws. Obviously not much will grow on their heads in only 28 days.

I find it hard to believe they would spend millions of dollars on a big ass phase II clinical trial (300 participants) if phase I werent what the company expected.

The data obtained was exciting enough for their investors/partners to push this forward.

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## KO1

Yep, this is the trial that matters....if it works, it will go to P3 presumably.

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## Swooping

> hmmm that sucks.  if you read the trial data though they were not really testing in any real way for efficacy. was just a safety trial with questions asked to the patients. whoever posted that comment could have misunderstood.   I think this actually sounds much more promising than CB. has big money behind it and tons of test locations for phase 2. good to see some research being applied, and i think in the near future a combo of something like this with an anti androgen could be really great.  just goes to show these things can come out of the blue.


 Fully agree. Way more exciting than cb-03-01. And phase 1 is primary safety indeed.

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## rdawg

> do you know why RU58841 dies in phase 1 ?


 It died in phase II and it was for a very good reason.

Finasteride was a simple take one a day drug that was cheap, RU had a much more complex way of treatment, was more expensive and seemed only slightly more effective. Essentially it wasn't worth it to release.

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## charlie76761

Great news re  http://www.clinicaltrials.gov/ct2/sh...dy/NCT02275351. 

V interesting they are looking for results at 45 and 90 days only rather than 6 mths for CB... could have a more accelerated effect.


But does anyone know the actual compound as there is someone who is v interested but cant 100% confirm the structure ... he may live in China  :Smile: 

apparently it's not here http://www.faqs.org/patents/app/20140005228

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## Boldy

> It died in phase II and it was for a very good reason.
> 
> Finasteride was a simple take one a day drug that was cheap, RU had a much more complex way of treatment, was more expensive and seemed only slightly more effective. Essentially it wasn't worth it to release.


 

the investors behind RU maybe  lost interest due to the competition and  easiness of finasteride.. only 1 magic pil a day and that's it.

back on-topic, a good gsk3b inhibitor or wnt agonist should be in each regieme, 

check this clinical trial with VPA:

(mice study) https://www.dropbox.com/s/je639j2ble...urine.pdf?dl=0



*Topical valproic acid increases the hair count in male
patients with androgenetic alopecia: A randomized,
comparative, clinical feasibility study using phototrichogram
analysis*

(VPA wnt inducer Human clinical trial) https://www.dropbox.com/s/klnqvyzqwn...0male.pdf?dl=0

Efficacy assessment
The representative clinical photographs and macrophotographs
are presented at baseline and after 24 weeks of treatment
(Fig. 2). The total hair count increased after 24 weeks of treatment
in the VPA group; the median hair counts were 181/cm2
(range, 125–241) at baseline and 192/cm2 (range, 153–271) at
24 weeks. However, the total hair count did not change in the
placebo group; the median hair counts were 194/cm2 (range,
155–244) at baseline and 197/cm2 (range, 132–253) at
24 weeks (Fig. 3a). The median change in total hair count from
the baseline was 23/cm2 (range, 17 to 39) in the VPA group
and 1/cm2 (range, 68 to 70) in the placebo group, and the
difference between groups was statistically significant
(P = 0.047; Fig. 3b)

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## charlie76761

Hi Boldy, interesting, do you know where supplies a proven GSK3B Inhib that works on Human MPB? Any reports on these forums of success plus compound and supplier

Our Chinese friend has sent me the attached that was produced in Jan but i'm not sure why it was developed and whether verified as working in Human MPB and if a ethan/PG vehicle would do the trick? Have you seen before?

Currently use neogenic with 20mg RU so wouldnt mind dropping in GSK3B... but only if the compound was directionally proven for MPB....

Thoughts?

Thanks

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## Boldy

The study i posted a post earlier proves that vpa works in humans, but less than minoxidil.

the treatments thus far are very limited due to damaged/aged cells. the key would be getting rid of these cells by superficial damage, . our best option now is to  to induce apoptosis in the cells by superficial damage, and get them replaced. we have enough stemcells, wnt/gsk3b inhibitors can help to turn the stemcells into progenitor cells into specialized cells. (on paper again), but that is our best option for now. the new cells wills till be aga cells, with other words precautions should be taken to halt aga.
ru/fin/dut etc..


that picture you attached is 6-bio. it is used in almost all vitro studies because it is one the most powerful gsk3b inhibitors out there
we did a 6-bio groupbuy in January with 5-10 people but not sure if anyone gave it a fair try.

http://www.ncbi.nlm.nih.gov/pmc/?term=gsk3+6+bio

https://www.dropbox.com/s/9rjdp5yn5x...pilla.pdf?dl=0

it is used to restore the dp inductive properties in Vitro without 3D culture..


it is never tried on humans before, but we know for example that it is 40.000 times stronger gsk3b inhibitor than Lithium that dr cots was experimenting with.


I have seen people trying Lithium, VPA/sodium valproate, 6-Bio,  but havent really seen wohw results thus far and I expect the same with Sm04554, limited results on its own. it would be interesting combined with wounding though.

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## hellouser

> The study i posted a post earlier proves that vpa works in humans, but less than minoxidil.
> 
> the treatments thus far are very limited due to damaged/aged cells. the key would be getting rid of these cells by superficial damage, . our best option now is to  to induce apoptosis in the cells by superficial damage, and get them replaced. we have enough stemcells, wnt/gsk3b inhibitors can help to turn the stemcells into progenitor cells into specialized cells. (on paper again), but that is our best option for now. the new cells wills till be aga cells, with other words precautions should be taken to halt aga.
> ru/fin/dut etc..
> 
> 
> that picture you attached is 6-bio. it is used in almost all vitro studies because it is one the most powerful gsk3b inhibitors out there
> we did a 6-bio groupbuy in January with 5-10 people but not sure if anyone gave it a fair try.
> 
> ...


 Isn't chlorine dioxide supposed to renew cells? Could this not potentially work in combination?

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## KO1

Precisely, wnt mimics are good enough to give us some growth, but what we need is to massively stimulate SCs to produce progenitor cells. Hence a wounding-topical combo, follica only used lithium, and vpa is better than lithium and still may not be enough. So a really potent promoter after wounding, on paper at least...

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## KO1

Cotsarelis should become aware of this drug.

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## charlie76761

Thanks for this Boldy - will see if i can find out any results with 6-bio but would presume no otherwise if wouldnt have escaped the normal hype! but that's not to say it couldnt still work...

Dont suppose you know anything abut SM04554 in terms of structure?

May be a bit tenuous, but believe i've found the patent but lacks molecular structure apparently 

http://www.faqs.org/patents/app/20140005228 

 i think this is the compound being used in Samumed's SM trials in San Diegeo - one the lead inventors listed on the patent works for Samumed as per https://www.linkedin.com/pub/sunil-kumar-kc/3/934/149 and the patent seems relevant in it's description 

 Further, looks the most likely from the other patents he's developed http://www.faqs.org/patents/inventor...an-diego-us-1/

Thoughts?

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## Swooping

I suppose it is either compound 1 , 2 or 3. But can't know for sure.. Compound 2 seems the most strongest from their essay.




> Administration and Pharmaceutical Compositions 
> 
> [0317] Some embodiments include pharmaceutical compositions comprising: (a) a safe and therapeutically effective amount of a compound according to Formulas I, II or III, or its corresponding enantiomer, diastereoisomer or tautomer, or pharmaceutically acceptable salt; and (b) a pharmaceutically acceptable carrier.

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## Tenma

Boldy, why do you think SM4554 wont regrowth much hair on its own? Maybe using it in conjuction with DUT or RU could be better?

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## Tenma

Maybe you are comparing sm potential effectiveness with VPA based on that small scale trial published some time ago.

I think the trial had some important limitations.  

According the investigators “the optimal dose and concentration of the VPA spray were not determined and higher concentration and dose of the VPA spray may be more effective for the treatment of AGA.”

"Of the 40 patients enrolled in the study, 27 (n = 15, VPA group; n = 12, placebo group) completed the entire protocol with good compliance."

27 is a really small sample size

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## inbrugge

And in the meanwhile we continue to grow balder...lol

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## Boldy

> Boldy, why do you think SM4554 wont regrowth much hair on its own? Maybe using it in conjuction with DUT or RU could be better?


 because we have had really potent gsk3b inhibitors (6-bio) this year, with limited results, although, it is not good to draw a conclusion on small group of people who tried it about 5-10. 

6-bio ic50 is about 5nm
Lithium 2mm 


with other words 6-bio is about 40.000 times stronger/ more selective in vitro.

as you can see it is really hard to out perform 6bio..


we might have to give it an another try with dermarolling or other mechanisms.


@ charlie I will look to the patent of smo, it might be logical to assume that they took compound 2, however it is not necessary that they picked compound 2, other factors play a role too like toxicology and binding on other receptor sites.

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## KO1

To be fair though, I believe lithium's potency in vivo exceeds its potency in vitro....that being said, I agree that just upregulating Wnt doesn't really solve the major problem of pushing the SC's to produce TACs...


Check out this....even more potent GSK-3b modulators than 6-BIO
http://www.ncbi.nlm.nih.gov/books/NBK133436/

I

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## Gjm127

> i think this is the compound being used in Samumed's SM trials in San Diegeo - one the lead inventors listed on the patent works for Samumed as per https://www.linkedin.com/pub/sunil-kumar-kc/3/934/149 and the patent seems relevant in it's description 
> Thoughts?


 Yeah! All makes sense, I had called the CB clinic in SD and the woman told me that in a month they'll be starting a new exciting treatment trial for hair loss but wouldn't give any specifics... This confirms that it was effectively SM that she was talking about!!! 

All in all: The SD clinic is recruiting for CB and SM trials!

----------


## Tenma

> Yeah! All makes sense, I had called the CB clinic in SD and the woman told me that in a month they'll be starting a new exciting treatment trial for hair loss but wouldn't give any specifics... This confirms that it was effectively SM that she was talking about!!! 
> 
> All in all: The SD clinic is recruiting for CB and SM trials!


 Good to hear. 

2016 will be THE year for us. I'm more excited about Sm though. Since Hamilton studies in the 60s  we know the therapeutic limits of the antiandrogenic angle (very little regrowth, long term maintenance).

WNT agonists and or GSK-3 inhibitors with wounding are the most promising things in the pipeline.

All that said, unlike others, i think CB will be released for AGA and it should be the really really effective for those young men intelligent enough to start using it at the very early stages of aga.

----------


## Boldy

> To be fair though, I believe lithium's potency in vivo exceeds its potency in vitro....that being said, I agree that just upregulating Wnt doesn't really solve the major problem of pushing the SC's to produce TACs...
> 
> 
> Check out this....even more potent GSK-3b modulators than 6-BIO
> http://www.ncbi.nlm.nih.gov/books/NBK133436/
> 
> I


 agree Ko1, but if a compound can inhibit  at uM dose, then its already ultra potent..


I still think that we could expect something from wounding/ Chlorine Dioxide  + strong gsk3 inhibitors.

----------


## KO1

We need something more than dermarolling, I think. Cotsarelis' work implied that we need a wound that doesn't close in on itself, so a pinprick style wound like needle woulnd't do it. We need to dermabrade  a decent surface area, say a few square cm's. Something like a chemical peel would work. Especially if we're doing this on slick bald scalp.

----------


## KO1

What do you guys think about using a topical like VPA or 6BIO to the donor site after FUE? All those wounds are there....

----------


## sdsurfin

Why do you guys think this SM drug will not work on its own? I'm assuming samumed has some hopes for efficacy if they are going ahead with such a large phase 2 trial...

I feel like I read a lot of armchair science on here, but as far as I know none of the guys on here have ever seen a wnt agonist used and tested in this capacity. whatever chemical you used is not the same as this one.  I'm not saying I have high hopes for anything, but why exactly should we be skeptical of this one?  Seems far more promising as a maintenance drug than CB or other antiandrogens, which have well known limitations.

----------


## Tenma

> Why do you guys think this SM drug will not work on its own? I'm assuming samumed has some hopes for efficacy if they are going ahead with such a large phase 2 trial...
> 
> I feel like I read a lot of armchair science on here, but as far as I know none of the guys on here have ever seen a wnt agonist used and tested in this capacity. whatever chemical you used is not the same as this one.  I'm not saying I have high hopes for anything, but why exactly should we be skeptical of this one?  Seems far more promising as a maintenance drug than CB or other antiandrogens, which have well known limitations.


 Maybe SM04554 alone can regrow a good amount of hair on diffuse thinners? lets hope thats the case. I certainly dont expect a NW 7 to NW1 reversal.

But, like you said, they are spending millions on a ph.II trial for a reason. Also that trial will be 3 times bigger than the one cosmo is conducting for cb. Expensive as f#ck...

Nevertheless, after reading Boldy and seeing some great results with a proper wounding protocol, i think our best chance to regrow a good amount of hair will come from the combination of wounding and potent GSK3 inhibitors.

----------


## KO1

How can we get the word out about this trial? I'd love for people from the community to sign up.

----------


## KO1

> Why do you guys think this SM drug will not work on its own? I'm assuming samumed has some hopes for efficacy if they are going ahead with such a large phase 2 trial...
> 
> I feel like I read a lot of armchair science on here, but as far as I know none of the guys on here have ever seen a wnt agonist used and tested in this capacity. whatever chemical you used is not the same as this one.  I'm not saying I have high hopes for anything, but why exactly should we be skeptical of this one?  Seems far more promising as a maintenance drug than CB or other antiandrogens, which have well known limitations.


 It is because AGA skin has too many problems going on, oxidation, senescence, apoptotic cells, loss of subcutaneous fat, immune system doing who knows what. Wounding gives us a chance to rebuild the skin.

As for these guys, they are not hair loss guys, they're primarily Wnt experts who are targeting the problem in the way they know best. I'm confident it will do something, because a weaker Wnt agonist like VPA is proven to grow hair, but I doubt it will be spectacular. Obviously, happy to be wrong.

----------


## Boldy

> Maybe SM04554 alone can regrow a good amount of hair on diffuse thinners? lets hope thats the case. I certainly dont expect a NW 7 to NW1 reversal.
> 
> But, like you said, they are spending millions on a ph.II trial for a reason. Also that trial will be 3 times bigger than the one cosmo is conducting for cb. Expensive as f#ck...
> 
> Nevertheless, after reading Boldy and seeing some great results with a proper wounding protocol, i think our best chance to regrow a good amount of hair will come from the combination of wounding and potent GSK3 inhibitors.


 I still have like 200-300mg 6-BIO in my freezer from the groupbuy, more than enough for 1 year trial. Im okay to donate some of it if someone is willing to photo document a proper wounding trial + this gsk3 inhibitor. a slick bald scalp would be an interesting test case.  it is this compound: http://www.sigmaaldrich.com/catalog/.../b1686?lang=en

Keep in mind that this stuff is experimental and stains red, so has to be used at night, or when no one can see you  :Smile:

----------


## Tenma

> I still have like 200-300mg 6-BIO in my freezer from the groupbuy, more than enough for 1 year trial. Im okay to donate some of it if someone is willing to photo document a proper wounding trial + this gsk3 inhibitor. a slick bald scalp would be an interesting test case.  it is this compound: http://www.sigmaaldrich.com/catalog/.../b1686?lang=en
> 
> Keep in mind that this stuff is experimental and stains red, so has to be used at night, or when no one can see you


 thanks man, but i'm not the experimental type of guy. Maybe someone else is interested in doing it though. It could be really interesting

What i am considering is wounding my hairline the way 2young2retire from stopag forum did.  His results were amazing, almost complete reversal

What if follica didnt release anything because the impossibility to "monetize" their wounding protocol?

----------


## macbeth81

> What if follica didnt release anything because the impossibility to "monetize" their wounding protocol?


 The Phase 2a results for Follica is in their patent. It is more likely it is not released because it is no better than minoxidil.

https://docs.google.com/viewer?url=p...0140079686.pdf

----------


## Tenma

> The Phase 2a results for Follica is in their patent. It is more likely it is not released because it is no better than minoxidil.
> 
> https://docs.google.com/viewer?url=p...0140079686.pdf


 
Really doubt thats the case given that cotsarelis himself stated follica phase 2 trials results were better than current treatments.

How much better? who knows...

----------


## sdsurfin

I guess that's true, but these things are all part of the same chain too. If you fix one link in the chain it can sometimes stop the other ones from happening. we have seen this already with anti androgens.  blocking androgens and starting the ant pathway up at the same time could possibly be a great combination.  add replicel to that and you can probably keep your hair for a long time.  It will be interesting to see how fast scientists can start replacing entire follicles, and even when they do, topicals like these will probably help a lot.  I'm not sure if i care enough about age to be slathering all these things on my head all the time, so i hope replicel proves to be a good maintenance option on its own, at least for a decade or so.

----------


## burtandernie

I think decent regrowth sells better than maintenance so you would assume they have something here. Assuming of course it works well enough for them to take farther. I dont know if anyone really knows what kind of results this approach would even achieve. NW 7 to NW 1? Seems more unlikely than not but I doubt anyone could say its impossible
What I like though is no one saw this coming. It came out of nowhere and hopefully it turns out well

----------


## sdsurfin

> I think decent regrowth sells better than maintenance so you would assume they have something here. Assuming of course it works well enough for them to take farther. I dont know if anyone really knows what kind of results this approach would even achieve. NW 7 to NW 1? Seems more unlikely than not but I doubt anyone could say its impossible
> What I like though is no one saw this coming. It came out of nowhere and hopefully it turns out well


 I've read a couple biotech guys say that this is not a huge thing. Might be as good as fin though, which would be great.  These pathways are so complex, I don't think a NW7 to NW1 situation is ever going to happen with a single chemical.  Maybe with a complex combination of treatments, and definitely with hair cloning in the not too distant future.  Either way , yeah good to see things coming out of the blue.

----------


## Tenma

> I've read a couple biotech guys say that this is not a huge thing. Might be as good as fin though, which would be great.


 They only conducted ph.I. I wonder how these biotech guys know about the potential effectiveness when not even Samumed tested the drug for that purpose yet

----------


## KO1

> The Phase 2a results for Follica is in their patent. It is more likely it is not released because it is no better than minoxidil.
> 
> https://docs.google.com/viewer?url=p...0140079686.pdf


 
This is not correct. Those results are the results of the CONTROL group, not the treatment.

----------


## KO1

> Really doubt thats the case given that cotsarelis himself stated follica phase 2 trials results were better than current treatments.
> 
> How much better? who knows...


 Do you have a reference for this? Very curious if true.

----------


## It's2014ComeOnAlready

> Do you have a reference for this? Very curious if true.


 I believe he's referring to the interview with Desmond. I believe his answer went something like this "2 million would bring a treatment better than minoxidil and propecia, 20 million would bring a treatment that could give a bald person a full head of hair, but will take more years to accomplish." 

I think it's very, very likely they do have something that's better than propecia + minox in the works, because of the PGD2 discovery and its significance, as well as the fact that Follica should not have any problem getting funded with $2 million. Puretech Ventures recently received $55 million for its current trials, and there's just no way that Follica didn't see any of that money with this kind of potential for a game-changing treatment.

----------


## KO1

Perhaps...I suspect that Cotsarelis needed a much more potent Wnt promoter than Lithium...These two outfits need to hook up methinks.

----------


## It's2014ComeOnAlready

I'm sure Cots knows what he's doing. He's obviously very cagey about their work, and while we on baldtruthtalk have phD's in bro-science, his knowledge is pretty significant.

----------


## KO1

Cots does not have a potent FDA approved Wnt promoter and has focused on drugs that are already FDA approved. Perhaps you should realize that some of us broscience PhD's have been following Cots' work for the better part of a decade before putting us down.

----------


## It's2014ComeOnAlready

> Cots does not have a potent FDA approved Wnt promoter and has focused on drugs that are already FDA approved. Perhaps you should realize that some of us broscience PhD's have been following Cots' work for the better part of a decade before putting us down.


 I wasn't trying to put anyone down, just saying that I'm sure he knows what he's doing.

----------


## KO1

> I wasn't trying to put anyone down, just saying that I'm sure he knows what he's doing.


 You have absolutely no idea what you're talking about, are unfamiliar with Cots' work, and should seriously consider not posting on these forums.

Finally, as of now Follica has not seen a single cent from Puretech Ventures' 55M raise.

----------


## It's2014ComeOnAlready

> You have absolutely no idea what you're talking about, are unfamiliar with Cots' work, and should seriously consider not posting on these forums.
> 
> Finally, as of now Follica has not seen a single cent from Puretech Ventures' 55M raise.


 Haha, you people are crazy. Maybe I won't post, so I don't have to deal with the vitriolic and insane responses when I've said nothing worthy of intense criticism. Plus, you miss the point of follica being cagey all along - so then, why would they let the world know (as well as other teams working on this issue) what they're working with? How do you know no money went to Follica? You don't, so shut it.

----------


## KO1

Because I looked at their SEC filings.

----------


## It's2014ComeOnAlready

> Because I looked at their SEC filings.


 Again, that's great but you weren't aware of their financial info before the $55 million investment. You really don't actually know much about what they've been up to or where they're at, and neither does anybody else on here. I'm just being positive, and yes, I should continue to post because I have informed and positive things to say. 

Congratulations on your phD in broscience and superior knowledge(?) about future hair loss treatments, even though not very much info has been released on follica's progress.

----------


## DeuceWillis

Guys, guys, guys... Calm down, don't argue with each other we're all balding here lmao. Technically no matter how much we patrol the Internet, research companies, keep up with trials, etc. etc... We are on a public forum, on the blind side of all advances, and are completely at their mercy when it comes to the publicity of their information. Anything on here is usually speculation and opinion. No better than people posting pics of their assh*les. Let's just be patient and see what they reveal.

----------


## hellouser

> You have absolutely no idea what you're talking about, are unfamiliar with Cots' work, and should seriously consider not posting on these forums.
> 
> *Finally, as of now Follica has not seen a single cent from Puretech Ventures' 55M raise.*


 Uh... how do you know that?

----------


## Shinobi

do we know the molecular structure of sm04554 ?

----------


## Swooping

Did anyone sign up for this trial? Would be awesome to get updated through the trial.

----------


## feartheundead

I am a part of this study. I just started this week. This is phase 2 of clinical trials. I will be on the medication for 3 months and then 1 month of follow up

----------


## Tenma

> I am a part of this study. I just started this week. This is phase 2 of clinical trials. I will be on the medication for 3 months and then 1 month of follow up


 Great man! Best of luck! It would be awesome if you can give us some feedback once the trial is completed. Or maybe sooner

----------


## Gjm127

> I am a part of this study. I just started this week. This is phase 2 of clinical trials. I will be on the medication for 3 months and then 1 month of follow up


 That's really cool that you came here. A lot of people here are very interested to get the most information about this as possible! Thanks a bunch for coming here and keeping us updated. 

How many times do you have to apply it per day? Would you know the composition of the topical? Any expectations given prior to starting?

I'm excited about this! Welcome aboard!

----------


## Swooping

> I am a part of this study. I just started this week. This is phase 2 of clinical trials. I will be on the medication for 3 months and then 1 month of follow up


 Great man! Would be great if you can tell us some more.

----------


## Sogeking

He might have signed NDA. I'm still gonna ask though, are you using Minox 5% as comparison? Can you at least tell us after 3 months which one is better?

----------


## KO1

> I am a part of this study. I just started this week. This is phase 2 of clinical trials. I will be on the medication for 3 months and then 1 month of follow up


 Hey man, do you have an email that we can reach you at? No PM's allowed....

----------


## Halo26

I'm also part of this study. I was just cleared to enroll. Same shcedule as feartheundead.

----------


## It's2014ComeOnAlready

> I'm also part of this study. I was just cleared to enroll. Same shcedule as feartheundead.


 Nice! Hope you get good results with it. Let us know how it goes (if you can).

----------


## Swooping

Hey guys, any updates? Thumbs up or thumbs down?

----------


## Gjm127

Any phase 1 results available online?

Candidates: have you been briefed with the potential effectiveness/safety information of the drug?

----------


## Hairismylife

Can this and Bim be the new Big 3, I have high hope

----------


## Tenma

.

----------


## Tenma

Lets hope man. CB, SM and Bim together may very well outperform min-ru-dut combo (my personal big 3).

----------


## rdawg

> Lets hope man. CB, SM and Bim together may very well outperform min-ru-dut combo (my personal big 3).


 I agree, CB the new version of FIN/DUT without the sides.

Bim a much better version of Minoxidil

SM i'm not sure? Isn't it a similar anti-androgen like CB?

Either way we seem to be in the early stages of simply upgrading older medication, nothing wrong with that, younger generations will be able to hold on to their hair and possibly grow a little back, still nothing that will turn a NW7-NW1 though.

----------


## It's2014ComeOnAlready

> I agree, CB the new version of FIN/DUT without the sides.
> 
> Bim a much better version of Minoxidil
> 
> SM i'm not sure? Isn't it a similar anti-androgen like CB?
> 
> Either way we seem to be in the early stages of simply upgrading older medication, nothing wrong with that, younger generations will be able to hold on to their hair and possibly grow a little back, still nothing that will turn a NW7-NW1 though.


 SM is a WNT pathway activator it seems. The recent discovery about how macrophages are necessary to tell stem cells to create hair are very important because macrophages activate WNT proteins. All of these newer applications are based on real science and should be effective. You shouldn't have to mess with hormones or reduce the size of your prostate to keep your hair. Woohoo! Now if they'd just hurry up.

----------


## It's2014ComeOnAlready

Follica better hurry up and get a treatment to market, unless they want another effective topical getting there first.

----------


## Sogeking

> Follica better hurry up and get a treatment to market, unless they want another effective topical getting there first.


 I don't think Follica has any intention of putting anything hair loss related to market. As Cotsarelis said to Desmond, they don't have the money...

----------


## It's2014ComeOnAlready

> I don't think Follica has any intention of putting anything hair loss related to market. As Cotsarelis said to Desmond, they don't have the money...


 You see, I don't understand this kind of logic. Desmond himself said that each group didn't show their full hand, so why would Cots to an "interviewer" who basically ambushed him? Their original plan clearly was to corner the hair loss market by providing a hair loss treatment based on real scientific evidence, and creating a procedure to make hair transplants unnecessary. The latter is obviously a lot harder and a lot more costly. 

The only way they would be able to tell if they'd been making progress with other chemicals other than a gpr44 blocker, would be use a topical gpr44 blocker and test compounds. It's a crucial part of even testing their ability to regenerate new follicles, because they would have to block what's inhibiting hair growth in the first place and then add growth factors. Cotsarelis has said himself that they made it through two trials, and I think that would infer that they have something to block that receptor. If it costs "$2 million to produce," and would make billions every year, why wouldn't any of that $55 million go to Follica? 

Not saying they'll have anything for sure, but I like what I see.

----------


## flappytom

I bet this is very promising combines with ru58841 or fin,dut

----------


## breakbot

This is the most exciting prospect in my opinion. It's based on the latest knowledge about aga and not all those prehistoric (only) dht stuff. 2015 will be the year where we will find out if any of sm, bim and cb will make it go through phase 3 (soon on market).

----------


## hellouser

> I don't think Follica has any intention of putting anything hair loss related to market. As Cotsarelis said to Desmond, they don't have the money...


 Then why the initial backing of Puretech Ventures with millions of dollars? Why all the years of (snail paced) work from Cotsarelis? Why waste all the time, money, man hours and effort only to NOT release a treatment?

----------


## It's2014ComeOnAlready

> Then why the initial backing of Puretech Ventures with millions of dollars? Why all the years of (snail paced) work from Cotsarelis? Why waste all the time, money, man hours and effort only to NOT release a treatment?


 They were launched about 9 years ago, have made it through two clinical trials. All their theories have been tested by science and passed with flying colors. The main thrust of their work would be to corner the hair loss market, with a far better topical treatment and a procedure that makes HT obsolete. I wonder what makes people think they've bowed out?

----------


## FearTheLoss

Anything from the guys who are testing?

----------


## SM04554 patient

Hello all, new to the board here. 

Start this trial today (USA). The doctor is extremely encouraged by the potential of this treatment, although the clinical research nurse with whom I spoke said she hasn't witnessed much growth in the patients she has seen thus far.

We shall see.

----------


## Justinian

> Hello all, new to the board here. 
> 
> Start this trial today (USA). The doctor is extremely encouraged by the potential of this treatment, although the clinical research nurse with whom I spoke said she hasn't witnessed much growth in the patients she has seen thus far.
> 
> We shall see.


 Good luck and keep us updated!

The trial only started a few months ago, and most treatments take several months to show progress, so it's not surprising that not much has been seen yet. It will also be interesting to add if this works in combination with other treatments.

----------


## sdsurfin

Doesn't sound too promising.

----------


## charlie76761

> Doesn't sound too promising.


 Minox wouldnt have looked too promising at all in the first month or two, in fact most good respondents shed heavily. And i doubt they got the correct % from the start (probably started at 2%)

Does anyone know what the compound is exactly so Kane can have an attempt at copying - i posted a likely candidate earlier in this thread

----------


## Justinian

> Minox wouldnt have looked too promising at all in the first month or two, in fact most good respondents shed heavily. And i doubt they got the correct % from the start (probably started at 2%)
> 
> Does anyone know what the compound is exactly so Kane can have an attempt at copying - i posted a likely candidate earlier in this thread


 The compound is actually 0.15 and 0.25%. https://www.clinicaltrials.gov/ct2/show/NCT02275351

It's a 300 person trial so they are putting a lot of money into this. They must think it's promising.

EDIT: Now that I think about it, it could also be a large # of people because they need to prove safety also, since it affects the wnt pathway.

----------


## charlie76761

> The compound is actually 0.15 and 0.25%. https://www.clinicaltrials.gov/ct2/show/NCT02275351
> 
> It's a 300 person trial so they are putting a lot of money into this. They must think it's promising.
> 
> EDIT: Now that I think about it, it could also be a large # of people because they need to prove safety also, since it affects the wnt pathway.


 Hi Justinian.. my 2% was reference to a guess at Minox concentration at first trials...   Great to know SM is 0.15 to 0.25% - just need to find the actual compound structure and properties

here were my thoughts on what the compound could be....

May be a bit tenuous, but believe i've found the patent but lacks molecular structure apparently 

http://www.faqs.org/patents/app/20140005228 

i think this is the compound being used in Samumed's SM trials in San Diegeo - one the lead inventors listed on the patent works for Samumed as per https://www.linkedin.com/pub/sunil-kumar-kc/3/934/149 and the patent seems relevant in it's description 

Further, looks the most likely from the other patents he's developed http://www.faqs.org/patents/inventor...an-diego-us-1/

Thoughts?

----------


## Gjm127

Don't you guys find it weird that we've never heard about this product before, there's no information on it on the web or elsewhere, and that we've all been told about this by doctors' secretaries as a new very interesting product that we could all enrol in?

*All of a sudden, we have 3-4 NEW members join this forum and state that they're in this trial in one comment and leave. We've never had that before for medication development phase trials, for any product... I'm just saying it's fishy.*

----------


## charlie76761

> Don't you guys find it weird that we've never heard about this product before, there's no information on it on the web or elsewhere, and that we've all been told about this by doctors' secretaries as a new very interesting product that we could all enrol in?
> 
> *All of a sudden, we have 3-4 NEW members join this forum and state that they're in this trial in one comment and leave. We've never had that before for medication development phase trials, for any product... I'm just saying it's fishy.*


 Yeah - guess you could argue that but for me you need to assess their end game and if you saying the company behind SM is not playing straight then i think we can have confidence in that they are currently in a large Phase II trial that is FDA regulated-   if they were found to fiddle that then company would be ruined and ppl could go to jail 

Personally i prefer a company that keeps its head down doesnt come out and boast about some drug...Cosmo were initially saying their CB could at least double new hair growth and then also hair shaft diameter etc. I'm doubting them more day by day and if being a pessimistic, i suspect that these early results were to drive investment (interestingly, their Jan 2015 update only spoke about CB's ability to widen the shaft and nothing back new growth...hmmm)

I'm quite excited about SM as these guys did a trial in Australia and now targeting USA which is known as a hard regulator landscape but has many multiples of size in terms of market... you could conclude that if they have found something that works, they are going about it as you would expect.  

And i guess, if they actually have something that works (and i mean really works) and the investment already in the bank, you may want to keep quiet so a big player rival doesnt come along and invest to produce a slightly diff compound but with same effect...

Lastly, there was at least one person in the CB trial posting on here (something about not seeing much growth at mth 2) so not unique for SM, and but why so many SM post... see here - seems to be massive trail given number of recruiting sites https://www.clinicaltrials.gov/ct2/s...dy/NCT02275351

I agree that the posts may are a bit odd and fishy but at the moment i'm more optimistic overall... look fwd to seeing how this plays out (good or bad)

----------


## sdsurfin

Fishy in what way? They are registered as doing FDA trials, most companies do not toot their horn at a new product until it is tested, unless they need investors.  This seems to be well funded.  It's weird that people came on here to say they are in the trial, but maybe they are not allowed to say anything else, or simply have lives to lead.  I personally don't have any hope for CB, from talking to a person at hygeia (who is "considering" trialling a new anti androgen for alopecia), CB is not even a real anti-androgen and is pretty weak sauce.  It got very overhyped for investors and then the goofs on this forum ran with it.  I have no idea about SM, another doctor mentioned that hairless is mrs complicated than just the wnt pathway, but if they are doing a big trial then hopefully it is useful for something.  I'm really not interested in anything I have to rub on my head every day, keeping my fingers that replicel comes out with a good preventative fix before things get too bad.

----------


## It's2014ComeOnAlready

> Fishy in what way? They are registered as doing FDA trials, most companies do not toot their horn at a new product until it is tested, unless they need investors.  This seems to be well funded.  It's weird that people came on here to say they are in the trial, but maybe they are not allowed to say anything else, or simply have lives to lead.  *I personally don't have any hope for CB, from talking to a person at hygeia (who is "considering" trialling a new anti androgen for alopecia), CB is not even a real anti-androgen and is pretty weak sauce*.  It got very overhyped for investors and then the goofs on this forum ran with it.  I have no idea about SM, another doctor mentioned that hairless is mrs complicated than just the wnt pathway, but if they are doing a big trial then hopefully it is useful for something.  I'm really not interested in anything I have to rub on my head every day, keeping my fingers that replicel comes out with a good preventative fix before things get too bad.


 You're spreading nonsense. No company would pay to do 2 or 3 trials if the compound was garbage. You post so much speculation based on what kind of mood you're in. From the majority of your posts, I'd say you're in a bad mood most of the time. Nobody on here needs it. Either you have some credible information, or you don't. You do not.

----------


## Sogeking

> You're spreading nonsense. No company would pay to do 2 or 3 trials if the compound was garbage. You post so much speculation based on what kind of mood you're in. From the majority of your posts, I'd say you're in a bad mood most of the time. Nobody on here needs it. Either you have some credible information, or you don't. You do not.


  Well we will see if he is right or not. Everything is a speculation so far. I'm just glad there are at least some treatments in the pipeline. 
You know that old Chinese proverb: "You miss 100% shots you don't take!"  :Big Grin:  Just kidding Gretzky said that.

----------


## FearTheLoss

They must have a lot of hope for this drug as they are only recruiting severely bald males. "Males between 18 and 60 years of age, inclusive
Diagnosed with androgenetic (AGA) alopecia with a Norwood-Hamilton Classification score of 4, 5, 6 or 7." 

Most trials would never consider recruiting a nw7.

----------


## charlie76761

> They must have a lot of hope for this drug as they are only recruiting severely bald males. "Males between 18 and 60 years of age, inclusive
> Diagnosed with androgenetic (AGA) alopecia with a Norwood-Hamilton Classification score of 4, 5, 6 or 7." 
> 
> Most trials would never consider recruiting a nw7.


 
Good spot - v interesting. Not sure what to conclude bar think they have something very powerful although impossible to say bar speculation. One hopes..

Very keen to understand the compound being used... can some ping Desmond and ask for this thoughts?

I've believe i've found the patent (or at least several candidates) 

http://www.faqs.org/patents/app/20140005228 

i think this is the compound being used in Samumed's SM trials in San Diegeo - one the lead inventors listed on the patent works for Samumed as per https://www.linkedin.com/pub/sunil-kumar-kc/3/934/149 and the his patents listed seems v relevant, e.g. one states

"..The method of the present invention is useful in the treatment of alopecia in mammals, and as such may be used to promote, increase, or assist in the growth of hair. Subjects may be male or female"

it is also around WNT signalling 


Sunil also has these patents... http://www.faqs.org/patents/inventor...an-diego-us-1/ - i think one of these is SM04554.. just need an expert to understand the difference between them and which is likely to be the compound... can then get out to Kane for synthesis

Thoughts?

----------


## FearTheLoss

I don't think this is something that we should be trying to replicate and experiment with. WNT pathways and signaling can potentially be dangerous. Granted, they already passed safety trials, I wouldn't trust a random chemist to make this for me.

----------


## Justinian

> I don't think this is something that we should be trying to replicate and experiment with. WNT pathways and signaling can potentially be dangerous. Granted, they already passed safety trials, I wouldn't trust a random chemist to make this for me.


 I think phase 2 serves as safety too.

Could this product be why histogen is having problems getting funding? It appears to work via a similar mechanism and is already in the middle of phase 2. If it is similar, that's good news because I remember seeing really good results from a histogen trial.

----------


## burtandernie

between this, bim and CB I have faith atleast one of them will make through to the finish line. I think in the next 5 years will actually turn out to be true this time. I hope all of them make it and work better than expected

----------


## It's2014ComeOnAlready

I think a lot sooner than 5 years, hair loss treatments will change big time. For the better.

----------


## Kudu

> I think a lot sooner than 5 years, hair loss treatments will change big time. For the better.


 This. People really need to quit saying that things aren't going to get better. Things may not be better yet, but they will be.

----------


## FearTheLoss

> This. People really need to quit saying that things aren't going to get better. Things may not be better yet, but they will be.


 I agree, there are so many advancements in the pipeline. 

We have Dr. Wesley bringing a scarless transplant with regeneration, how much? we will see. 

We have this, bim, CB, histogen (maybe), and replicel all in the pipeline. Further, there are many docs experimenting with various forms of PRP therapy that will eventually be a viable treatment. I have seen some great PRP results, and it's a matter of time before the optimal formula is found. 

Next, we still have Dr. Cole experimenting with various ways to improve donor regeneration. I know he's working hard to improve the field and I wouldn't be surprised if we eventually see him offering regeneration with his hair transplants. 

Then we have the cellular advancements being made, sure it could be 30 years before they figure it out, but at the rate they've been increasing their knowledge in the field and making advancements lately, I'd bet it will be before 2020 that they've figured it out, then they go through FDA hell though.

----------


## It's2014ComeOnAlready

> I agree, there are so many advancements in the pipeline. 
> 
> We have Dr. Wesley bringing a scarless transplant with regeneration, how much? we will see. 
> 
> We have this, bim, CB, histogen (maybe), and replicel all in the pipeline. Further, there are many docs experimenting with various forms of PRP therapy that will eventually be a viable treatment. I have seen some great PRP results, and it's a matter of time before the optimal formula is found. 
> 
> Next, we still have Dr. Cole experimenting with various ways to improve donor regeneration. I know he's working hard to improve the field and I wouldn't be surprised if we eventually see him offering regeneration with his hair transplants. 
> 
> Then we have the cellular advancements being made, sure it could be 30 years before they figure it out, but at the rate they've been increasing their knowledge in the field and making advancements lately, I'd bet it will be before 2020 that they've figured it out, then they go through FDA hell though.


 I also have faith in follica, at least for a new treatment. If bim turns out to be successful, it could prove a lot with regards to hair loss and prostaglandins. If a pharmaceutical company hasn't been working with them already on a new treatment, then they will jump at the chance if they see that bimatoprost is successful. We know they are at most, one clinical trial away from releasing a hair loss product, so either way I think we should see something. 

Being quiet doesn't necessarily mean "dead." That's not how their company operates, and while it's frustrating, I've been following follica closely, and based on every bit of evidence, it's quite hard to believe that a pgd2 inhibitor product won't be available soon. They even mention in their patent that it would be used with a pgf2 analog, and the potential for billions is just too great to pass up on. Plus as we can see, there are a number of other companies working on treatments. It's open season since minoxidil and propecia's patents have run out.

----------


## Hicks

> Next, we still have Dr. Cole experimenting with various ways to improve donor regeneration. I know he's working hard to improve the field and I wouldn't be surprised if we eventually see him offering regeneration with his hair transplants.


 He already does if you look at his website.  I have no earthly idea if regeneration is really 50% on average, but why would he advertise that on this forum with all the Interent Rangers set to blast him or anyone that says something.  IMO it gives him or anyone no strategic advantage in business. Dr. Wesley is throwing us a bone and we eat it and him in the process.  There are some impressive photos of PRP treatment yet some blast it and mention Min to others on a seperate thread.  Best of luck everyone!  I hope we get something that makes the big 3 look like M&Ms this year.

----------


## FearTheLoss

> He already does if you look at his website.  I have no earthly idea if regeneration is really 50% on average, but why would he advertise that on this forum with all the Interent Rangers set to blast him or anyone that says something.  IMO it gives him or anyone no strategic advantage in business. Dr. Wesley is throwing us a bone and we eat it and him in the process.  There are some impressive photos of PRP treatment yet some blast it and mention Min to others on a seperate thread.  Best of luck everyone!  I hope we get something that makes the big 3 look like M&Ms this year.


 Yeah, Dr. Wesley hasn't been posting about it lately. It's tragic how poorly he was treated by some members here. We get doctors working to improve our lives, like him and Dr. Gardner, and then some of the crazy people on the forum scare them away so we no longer get the communication they were taking time out of their busy lives to give us.

----------


## hellouser

> Yeah, Dr. Wesley hasn't been posting about it lately. It's tragic how poorly he was treated by some members here. We get doctors working to improve our lives, like him and Dr. Gardner, and then some of the crazy people on the forum scare them away so we no longer get the communication they were taking time out of their busy lives to give us.


 You'd think his absence would be a good thing if he really was working on pilofocus...

----------


## Halo26

> Hello all, new to the board here. 
> 
> Start this trial today (USA). The doctor is extremely encouraged by the potential of this treatment, although the clinical research nurse with whom I spoke said she hasn't witnessed much growth in the patients she has seen thus far.
> 
> We shall see.


 SM04554 patient, how many patients had the nurse seen already? Which site are you at? I'm at the Encinitas site--really hoping this is going to work...

----------


## sdsurfin

Here is the patent for the compounds that Samumed is testing. Somewhere in here is the formula for SM04554.  This contains some more info on how this works, basically it promotes wnt signaling, which I know nothing about, but which seems to be pretty central to hair loss and a whole lot of other things.  I have some hope for this drug especially as a maintenance drug, but really who know what side effects it could have.  At least it prob won't kill your dick.  hormonally based treatments are garbage, this seems more to the point.  It's possible that kane or someone could make this if they study the patents enough, there are diagrams of the molecules, but some guesswork to do for sure. 
--------------------------



One embodiment of a Wnt/β-catenin signaling pathway activator disclosed herein includes a compound having the structure of Formula I:


 Figure US20120046320A1-20120223-C00001
R1 is selected from the group consisting of substituted or unsubstituted heteroaryl and substituted or unsubstituted heterocyclyl, with the proviso that a carbon atom is attached to the carbonyl;

R2 is selected from the group consisting of substituted or unsubstituted aryl, substituted or unsubstituted heteroaryl, substituted or unsubstituted carbocyclyl and substituted or unsubstituted heterocyclyl, with the proviso that a carbon atom is attached to the carbonyl; and

R3, R4, R5 and R6 are independently selected from a group consisting of H, —C1-9alkyl, —C1-9alkylaryl and —C1-9alkylheteroaryl.

Another embodiment of a Wnt/β-catenin signaling pathway activator disclosed herein includes a compound having the structure of Formula II:


 Figure US20120046320A1-20120223-C00002
R1 is selected from the group consisting of substituted or unsubstituted heteroaryl and substituted or unsubstituted heterocyclyl, with the proviso that a carbon atom is attached to the carbonyl;

R2 is selected from the group consisting of substituted or unsubstituted aryl, substituted or unsubstituted heteroaryl, substituted or unsubstituted carbocyclyl and substituted or unsubstituted heterocyclyl, with the proviso that a carbon atom is attached to the carbonyl; and

R3 and R4 are independently selected from a group consisting of H, —C1-9alkyl, —C1-9alkylaryl and —C1-9alkylheteroaryl.

Another embodiment of a Wnt/β-catenin signaling pathway activator disclosed herein includes a compound having the structure of Formula III:


 Figure US20120046320A1-20120223-C00003
R1 is selected from the group consisting of substituted or unsubstituted aryl, substituted or unsubstituted heteroaryl, substituted or unsubstituted carbocyclyl and substituted or unsubstituted heterocyclyl, with the proviso that a carbon atom is attached to the carbonyl;

R2 is selected from the group consisting of substituted or unsubstituted aryl, substituted or unsubstituted heteroaryl, substituted or unsubstituted carbocyclyl and substituted or unsubstituted heterocyclyl, with the proviso that a carbon atom is attached to the carbonyl; and

R3 and R4 are independently selected from a group consisting of H, —C1-9alkyl, —C1-9alkylaryl and —C1-9alkylheteroaryl.

Some embodiments include stereoisomers and pharmaceutically acceptable salts of a compound of Formulas I, II or III.

Some embodiments include pro-drugs of a compound of Formulas I, II and III.

Some embodiments of the present invention include pharmaceutical compositions comprising a compound of Formulas I, II or III and a pharmaceutically acceptable carrier.

Another embodiment disclosed herein includes a pharmaceutical composition comprising a compound according to any of the above formulas and a pharmaceutically acceptable carrier, diluent, or excipient.

Some embodiments of the present invention include methods to prepare compounds of Formulas I, II or III.

It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the invention, as claimed.

DETAILED DESCRIPTION OF THE INVENTION
*It has been discovered that β-diketones, γ-diketones and γ-hydroxyketones are capable of activating the Wnt/β-catenin signaling pathway.* The Wnt/β-catenin signaling pathway has been found to play a crucial role in the differentiation and development of nerve cells for the central nervous system, bone formation, hair follicle development and regeneration, and stimulation of stem cell growth, maintenance and differentiation.

The present invention relates a method for increasing cell or tissue regeneration in a vertebrate subject. The invention relates to methods for increasing the successful activity of embryonic and/or adult stem cells, progenitor cells, mesenchymal progenitor/stem cells, or differentiated cells in vivo in a vertebrate subject. The invention further relates to methods for increasing cell or tissue regeneration in a vertebrate subject by administering a compound according to Formulas I, II or III to the vertebrate subject in need thereof, and increasing in vivo a stem cell, progenitor cell population, or differentiated cell in the vertebrate subject compared to the stem cell or progenitor cell, or differentiated cell population in the vertebrate subject before treatment, to increase cell or tissue regeneration in the vertebrate subject. A method for increasing stem cell or progenitor cell population is provided to repair or replace damaged tissue in a vertebrate subject, wherein the cell or tissue regeneration occurs in bone, chondrocytes/cartilage, muscle, skeletal muscle, cardiac muscle, pancreatic cells, endothelial cells, vascular endothelial cells, adipose cells, liver, skin, connective tissue, hematopoietic stem cells, neonatal cells, umbilical cord blood cells, fetal liver cells, adult cells, bone marrow cells, peripheral blood cells, erythroid cells, granulocyte cells, macrophage cells, granulocyte-macrophage cells, B cells, T cells, multipotent mixed lineage colony types, embryonic stem cells, mesenchymal progenitor/stem cells, mesodermal progenitor/stem cells, neural progenitor/stem cells, or nerve cells.

*Hair Growth

Compositions comprising compounds according to Formulas I, II or III can be used to promote hair growth.

“Promoting hair growth” refers to maintaining, inducing, stimulating, accelerating, or revitalizing the germination of hair.

The method of the present invention is useful in the treatment of alopecia in mammals, and as such may be used to promote, increase, or assist in the growth of hair. Subjects may be male or female. The term alopecia refers to both the complete absence of hair in skin which typically exhibits hair growth, as well as to a loss or diminution in the amount of hair. Multiple types and causes of alopecia are recognized in humans, including male pattern baldness, chemotherapy induced hair loss, congenital alopecia, and alopecia areata. The term treating alopecia refers to both the treatment of skin with a total absence of hair growth as well as the treatment of skin having reduced or patchy hair growth. Successful treatment results in an increased number of hairs.

Subjects to be treated according to the invention include human subjects as well as other mammalian subjects, such as dogs, cats, mice, rats, goats, llamas, minks, seals, beavers, ermines, and sheep. These can be treated for hair loss due or simply for enhancing wool or pelt production.

“Treating alopecia” refers to (i) preventing alopecia in an animal which may be predisposed to alopecia, (ii) inhibiting, retarding or reducing alopecia, (iii) promoting hair growth and/or (iv) prolonging the anagen phase of the hair cycle.

A method for promoting hair growth in accordance with the present invention is characterized by applying an effective amount of a compound according to Formulas I, II or III, or a pharmacologically acceptable salt thereof on the skin of mammals and in particular, on human scalp.*

----------


## sdsurfin

Interestingly, curcumin (main ingredient in turmeric) is a b-dyketone, which is what Sm is too I think.  Curcumin has been touted for hair loss, but i don't think there's been much success. However, I think it would have to be applied topically, and it is yellow. I hope Sm is more useful than curcumin, the Wnt thing seems tricky because you need a very powerful agent, and this pathway is implicated in a lot of things, so messing with it in drastic ways is probably dangerous.  I'm really curious to get more inside info from the people in the trial. or if anyone is in touch with researchers or dermatologists, especially in san diego, you should look into it and see what people say.

----------


## charlie76761

Hi sdsurfin, sounds like you have some knowledge, but why do you think that is the patent? Be good to understand. Thanks

----------


## sdsurfin

Well these are the recent patents filed by samumed. And if you read it it talks about hair loss. If sm is different then it has not been filed for patent. I tried looking up the specific drug name and found nothing.

----------


## charlie76761

Good man although read my post earlier - one of the lead chemist at Samumed in the Wnt area has registered about 10 odd patents on Wnt in the last year or two and most hair loss. We need to know the exact one - as you say wnt is complex and potentially w collateral consequence  

We need a professional biological chemist to help us out here. This compound and company interest me as unlike most others, they're not singing from the rooftops about small sample results - they seem very quietly confident not to mention only testing on nw7 to 4 - could be a powerful

----------


## KO1

Has anybody tried to get into their clinical trial? THey are still recruiting apparently. Typically they require that you do not take fin and minox etc.

----------


## FearTheLoss

I would have tried but you have to be at least a nw4.

----------


## Swooping

Any updates from actual participants in this trial? Would be great!

----------


## rdawg

> Any updates from actual participants in this trial? Would be great!


 problem here is 66% of the people in the trial will receive either placebo or minoxidil i believe, so some people here may not be getting results but that could be due to not actually getting the product!

----------


## Swooping

> problem here is 66% of the people in the trial will receive either placebo or minoxidil i believe, so some people here may not be getting results but that could be due to not actually getting the product!


 Damn good point. So even if they would get growth it could potentially be from the minoxidil... Hope they release the results asap when the trial is done then!

----------


## KO1

Men who do not take finasteride, we need you!!!

----------


## thinning44

Unless I am missing something, I don't see finasteride as part of the trial. In fact, anyone who has used in the 24 weeks prior to the trial is excluded. 

One of the exclusion criteria: 
Use of any products or devices purported to promote scalp hair growth (e.g., finasteride or minoxidil) within the 24 weeks prior to study start
See the trial details below:
https://www.clinicaltrials.gov/ct2/show/NCT02275351

----------


## KO1

Yes, that is what I'm saying, fin users can't join. Otherwise I would. Couldn't do the aderans trial for same reason despite living down the street from their trial location.

----------


## thinning44

Sorry, my response more for rdawg and swooping's point about results possibly being confounded by minoxidil. The way I read the trial I don't see that possibility.

----------


## kantian

I can't find any information on SM and its effectiveness/safety. If somebody can point me to legitimate information, that'd be great. 

I tried to join the clinical trial in Lynchburg, VA, but was shot down because I'm only Norwood 3. They are taking only Norwood 4 - 5 which tells me that SM is potentially very powerful. 

Here is the link to the clinical trial. Maybe some of you can actually attend: https://www.clinicaltrials.gov/ct2/show/NCT02275351

----------


## KO1

^I think they are looking for crown baldness?

----------


## kantian

I do have crown baldness. It's just not enough crown baldness for them.

----------


## KO1

> I do have crown baldness. It's just not enough crown baldness for them.


 damn dude, did they physically see your hair? Have any NW4-5 friends?  :Smile:

----------


## Seuxin

Hello guy's,

If all is ok, when could be SM released.
And what will be the form : topical, oral ?

Thanks  :Smile:

----------


## lifelonglearning

any news on this?

----------


## sdsurfin

still in trials

----------


## Seuxin

I really think SM could be very good ! I hope we could have soon results ! Any idea for a result release ??  6 month to wait ? More ? Less ?

----------


## Sogeking

> I really think SM could be very good ! I hope we could have soon results ! Any idea for a result release ??  6 month to wait ? More ? Less ?


 No idea mate. I know they started in the beginning of this year but everything else is a mystery.
So there current Phase 2 trials could last 6 months a year or more Although someone in this thread mentioned they expected some results after 3 months.
I would really like to see Phase 2 results after 3 and 6 month mark, just so we could know if there is any point in waiting for this.

----------


## It's2014ComeOnAlready

Their phase 2 ends in Sept. There are a few encouraging things about this drug. 1. It increases WNT pathway activation, which has shown to be important for hair growth. 2. They recruited only norwood 4-5, indicating the drug could be powerful for regrowth. 3. They recruited 300 participants for phase 2, which is unusual, and a very large number. It would indicate that they plan on this drug working very well, because the cost is greater for more participants, as well as having the ability to immediately jump into phase 3, because of the number of people already recruited. 

I'm definitely intrigued.

----------


## Swooping

If anything can pull of something greatly I believe it may be this drug. Hopefully they will come forward with the results immediately then in September. The WNT pathway is hugely implicated in hair follicle cycling & even morphogenesis.

----------


## It's2014ComeOnAlready

Very interesting that studies from UPenn back up this kind of work with the WNT pathway in regard to hair loss. I'm very excited for this drug's potential, and where it is in clinical trials. Will be done with phase 2 sooner than Breezula (CB-03-01) and is testing on a much larger group (60 vs. 300 participants)

Here's a press-release from UPenn (where Cotsarelis works!) : http://www.uphs.upenn.edu/news/News_...013/12/millar/

----------


## It's2014ComeOnAlready

Also want to add that I've checked the clinicaltrials.gov archive for changes made to the record, to see if and when they added recruitment changes or added locations for recruitment. Seems they added recruitment locations in both Feb and March, 4 & 5 months after the study had begun, which would indicate they are gearing up for a phase 3. Otherwise, they wouldn't be recruiting in so many locations, after a length of time enough to see results from phase 2 studies. The clinical trial study page was also updated in March 2015, so the info is up to date.

Gonna keep an eye on this one. Looks quite good.

----------


## runrunrun

So, when do you expect SM(&BIM) to release? 
Is it possible to see that products in 2018??

----------


## BiqqieSmalls

It will be an interesting Fall indeed! 

SM04554 will finish Phase II in September 
CB-03-01 will finish Phase II in November

----------


## It's2014ComeOnAlready

> So, when do you expect SM(&BIM) to release? 
> Is it possible to see that products in 2018??


 Probably around that time, maybe sooner. I'm getting a bit more anxious about bim, because there's no mention on clinical trials of a phase 3 right now. 

SM is looking really good though - they are definitely recruiting for a phase 3, which is an excellent sign. In phase 2, the biggest questions are efficacy and safety. To see that they are doing a lot more recruiting 5 months after the start of phase 2 is really encouraging. Also, there's a lot of science and basis to believe their drug will work. Look for scientific journals on the WNT pathway and hair growth, there's excellent science behind it.

----------


## Tenma

> SM is looking really good though - they are definitely recruiting for a phase 3, which is an excellent sign.


 How on earth do you know that??

If so, great news

----------


## It's2014ComeOnAlready

> How on earth do you know that??
> 
> If so, great news


 It doesn't outright say that outright (and it never will), but with enough digging, it can be determined with the records on clinicaltrials.gov. 

1. Their trial started in Nov with 300 participants (about the maximum for a phase 2). 2. According to this record, they added recruitment locations, and began recruiting for more patients in Feb and March (4 & 5 months after phase 2 began, which would be long enough to determine whether or not the medication was working). Here's the record, it tells of updates and such: https://clinicaltrials.gov/archive/NCT02275351. 3. Phase 3's are larger than phase 2 with up to thousands of patients. 4. Their clinical trial page, was last updated at the end of march, so their recruitment status is valid. Why else would they be recruiting at 25 locations at this point in the trial unless they intended to go to phase 3?

I don't give a crap about things like follicept, that's like crack to someone on a hair loss forum, but I doubt it will work. Check out scientific journals related to the WNT pathway and hair growth, it tells A LOT.

----------


## lifelonglearning

The only negative thing i could find was this 

"OncoMed Halts Wnt Pathway Inhibitor Trials due to bone side effects. What does this mean for programs at #Samumed?"

http://www.dddmag.com/news/2014/06/o..._zVRyQ.twitter

----------


## sdsurfin

> It doesn't outright say that outright (and it never will), but with enough digging, it can be determined with the records on clinicaltrials.gov. 
> 
> 1. Their trial started in Nov with 300 participants (about the maximum for a phase 2). 2. According to this record, they added recruitment locations, and began recruiting for more patients in Feb and March (4 & 5 months after phase 2 began, which would be long enough to determine whether or not the medication was working). Here's the record, it tells of updates and such: https://clinicaltrials.gov/archive/NCT02275351. 3. Phase 3's are larger than phase 2 with up to thousands of patients. 4. Their clinical trial page, was last updated at the end of march, so their recruitment status is valid. Why else would they be recruiting at 25 locations at this point in the trial unless they intended to go to phase 3?
> 
> I don't give a crap about things like follicept, that's like crack to someone on a hair loss forum, but I doubt it will work. Check out scientific journals related to the WNT pathway and hair growth, it tells A LOT.


 

This is nonsense.  You might be the most egregious speculator on this forum.  There are many reasons companies do things and many reasons that they could be recruiting more people. also, there is no difference in the amount of researching linking IGF-1 to hair growth as there is research on the ant pathway.  I agree SM could be great, but WE HAVE NO IDEA whether this has been successful so far.  Stop randomly deciding what companies plans are based on your hopes.

----------


## It's2014ComeOnAlready

> This is nonsense.  You might be the most egregious speculator on this forum.  There are many reasons companies do things and many reasons that they could be recruiting more people. also, there is no difference in the amount of researching linking IGF-1 to hair growth as there is research on the ant pathway.  I agree SM could be great, but WE HAVE NO IDEA whether this has been successful so far.  Stop randomly deciding what companies plans are based on your hopes.


 So, currently recruiting more participants, adding recruitment sites 4 and 5 months into a trial is a bad thing? Why would they recruit more participants if things were going poorly? Are phase 3's bigger than phase 2's, hell yeah. What other purpose is there than to recruit more participants nearly 7 months into a phase 2, other than purpose of recruiting them for a phase 3. Give me an answer. 

I'm sure the people over at Samumed have said to themselves: "So things are going poorly for SM after 6 months of trials for safety and efficacy. Time to recruit more participants, and have an ongoing recruitment all the while." Let's say they needed to do a phase 2b like bim did, they wouldn't recruit more participants. If things were going poorly, they wouldn't recruit more participants, and add testing sites. PERIOD.

How is using logic that recruiting in 25 locations, and adding participants and locations more than halfway through a trial, egregious speculation? THEY ARE EXPANDING THEIR AMOUNT OF PARTICIPANTS WHILE PHASE 2 IS MORE THAN 6 MONTHS COMPLETE. THESE ARE FACTS. What do you know? You're not BTT police, and what I'm saying makes a lot of sense. Sorry you can't add 1+1

----------


## It's2014ComeOnAlready

> The only negative thing i could find was this 
> 
> "OncoMed Halts Wnt Pathway Inhibitor Trials due to bone side effects. What does this mean for programs at #Samumed?"
> 
> http://www.dddmag.com/news/2014/06/o..._zVRyQ.twitter


 SM04554 is a WNT pathway activator, not an inhibitor. Also, on the clinical trial page it says this drug at the administered doses are not designated as a safety issue.

----------


## Seuxin

Is there actually a way to activate wnt pathway ? A way...available of course  :Wink:

----------


## sdsurfin

> So, currently recruiting more participants, adding recruitment sites 4 and 5 months into a trial is a bad thing? Why would they recruit more participants if things were going poorly? Are phase 3's bigger than phase 2's, hell yeah. What other purpose is there than to recruit more participants nearly 7 months into a phase 2, other than purpose of recruiting them for a phase 3. Give me an answer. 
> 
> I'm sure the people over at Samumed have said to themselves: "So things are going poorly for SM after 6 months of trials for safety and efficacy. Time to recruit more participants, and have an ongoing recruitment all the while." Let's say they needed to do a phase 2b like bim did, they wouldn't recruit more participants. If things were going poorly, they wouldn't recruit more participants, and add testing sites. PERIOD.
> 
> How is using logic that recruiting in 25 locations, and adding participants and locations more than halfway through a trial, egregious speculation? THEY ARE EXPANDING THEIR AMOUNT OF PARTICIPANTS WHILE PHASE 2 IS MORE THAN 6 MONTHS COMPLETE. THESE ARE FACTS. What do you know? You're not BTT police, and what I'm saying makes a lot of sense. Sorry you can't add 1+1


 Maybe they weren't getting the data they wanted. maybe they needed more participants in order to determine efficacy. maybe there were problems at the other testing sites, funding ran out at some, maybe the people who signed up didn't all follow through. maybe some test centers fell through.  How many times has replicel been delayed due to testing logistics? there are a million things that could result in needing more people or test sites. sure, one of them could be that its going well and they want to expand the test. however, on the same token, if it was going great why would they need to test more people?  Sure, it could be because they are foreseeing a phase 3 trial, but if you look at how companies run these tests they have to comply with the FDA, present results, and then move ahead accordingly.  this is why we always see time delays between trials, the parameters change, things need to be set, its a bureaucracy. its much more likely that they need more participants and test sites due to one of many other possibilities.  

you could also be correct. who the hell knows. the point is that you state your hunches as fact, when they are anything but.  You take one fact and you spin it into a reality of your own making based on your hopes.  you did the same thing with bimatoprost, and right now none of us can guess whether that treatment will even see daylight.  No one knows for sure what these companies are doing or why they are doing it unless you happen to work for them or have inside info, which you don't.  I'm not saying you shouldn't have high hopes or be encouraged by news that sounds good, just stop stating your wild guesses as fact.

----------


## Nerve

> I don't give a crap about things like follicept, that's like crack to someone on a hair loss forum,


 Can you explain this comment?

----------


## diffuseloser

sdsurfin is right. They could be recruiting for any number of reasons. It is, however, an encouraging sign but we don't know anything at this stage and cannot presume anything.

----------


## Swooping

> I don't give a crap about things like follicept, that's like crack to someone on a hair loss forum, but I doubt it will work. Check out scientific journals related to the WNT pathway and hair growth, it tells A LOT.


 lol!




> This is nonsense.  You might be the most egregious speculator on this forum.  There are many reasons companies do things and many reasons that they could be recruiting more people. also, there is no difference in the amount of* researching linking IGF-1 to hair growth as there is research on the ant pathway.*  I agree SM could be great, but WE HAVE NO IDEA whether this has been successful so far.  Stop randomly deciding what companies plans are based on your hopes.


 Shame on you sdsurfin. There is way way way more research regarding the WNT pathway as there is to IGF-1 in regards to hair follicle biology. How can you even compare the two? WNT is one of the first signals which leads to de-novo morphogenesis of hair follicles, together with SHH. Ablation of it leads to total retardation of hair follicles. Furthermore it maintains a highly prevalent role in anagen onset (literally moments before anagen) and holds a really important role in hair follicle cycling itself. Sorry dude, IGF-1 is nothing literally nothing to WNT in the importance of hair follicle biology. It functions on so many more things downstream.

Not only that there is even evidence arising from the pathway up to a genetic level in androgenetic alopecia; 

http://www.ncbi.nlm.nih.gov/pubmed/23358095




> Androgenetic alopecia: identification of four genetic risk loci and evidence for the contribution of WNT signaling to its etiology.


 http://publicatio.bibl.u-szeged.hu/4816/




> A Synonymous Polymorphism of APCDD1 Affects Translation Efficacy and is Associated with Androgenic Alopecia


 Do your homework better sdsurfin, I expect a better response from you next time.

----------


## It's2014ComeOnAlready

> Can you explain this comment?


 Check the view count on the follicept thread - it's like 250,000 and no one even knows if this stuff works. The only reason for that is they claim that it works, and don't have to pass FDA trials. When something seems too good to be true, most the time it is.

----------


## It's2014ComeOnAlready

> *Maybe they weren't getting the data they wanted. maybe they needed more participants in order to determine efficacy. maybe there were problems at the other testing sites, funding ran out at some, maybe the people who signed up didn't all follow through. maybe some test centers fell through.  How many times has replicel been delayed due to testing logistics? there are a million things that could result in needing more people or test sites. sure, one of them could be that its going well and they want to expand the test. however, on the same token, if it was going great why would they need to test more people?*  Sure, it could be because they are foreseeing a phase 3 trial, but if you look at how companies run these tests they have to comply with the FDA, present results, and then move ahead accordingly.  this is why we always see time delays between trials, the parameters change, things need to be set, its a bureaucracy. its much more likely that they need more participants and test sites due to one of many other possibilities.


 "Maybe they weren't getting the data they wanted." - Really, with the maximum allowed phase 2 (300) number of participants they couldn't get the data they wanted? That's a very uninformed joke.

"Maybe they needed more participants to determine efficacy." - You should do your homework on clinical trials, 300 is typically the maximum allowed for phase 2. If there was an issue with efficacy, concentration etc, they already have their participants. They wouldn't expand their recruitment, and include more locations for recruitment.

"Maybe there were problems at the other testing sites, funding ran out at some." - If there were problems with funding etc, then why are the original testing sites still posted, in addition to new ones? No subtraction here, only addition. Doesn't sound like a funding issue.

"Maybe some people who signed up didn't all follow through." - Really dude? You've got people on here rubbing unregulated chemicals on their heads out of desperation, and someone who is part of a trial for hair loss is just as desperate for something. Doubtful they don't keep up with the trial, they WANT something to work.

"If it was going great why would they need to test more people?" - They have the maximum number of participants for a phase 2 (don't believe me, you can look it up). If it was going great nearly 7 months in, and they chose to recruit more people at 25 locations, it's probably because they are gearing up for a phase 3 in which they need 1,000 to 3,000 test subjects. Please think logically for this one - 4,5,6 months in, they could determine some efficacy, at the same time they also have another 6 months to recruit subjects. At this point in time, it is logical to recruit more participants if things are going well and are determined to go into phase 3. It's called preparation. There's also no logical reason to expand recruitment at this point  unless things were going well. 

I'm sorry, you haven't provided anything concrete.

----------


## macbeth81

I would suspect they could not find enough participants at their existing sites and/or would rather open a new site than wait for new recruits.

These guys must have some deep pockets either way.

----------


## Tenma

> I would suspect they could not find enough participants at their existing sites and/or would rather open a new site than wait for new recruits.
> 
> These guys must have some deep pockets either way.


 thats exactly what i think. finding 300 participants isnt easy at all.

 but is good news they are recruiting and like you said shows how well they are financially speaking

----------


## Sogeking

> It doesn't outright say that outright (and it never will), but with enough digging, it can be determined with the records on clinicaltrials.gov. 
> 
> 1. Their trial started in Nov with 300 participants (about the maximum for a phase 2). 2. According to this record, they added recruitment locations, and began recruiting for more patients in Feb and March (4 & 5 months after phase 2 began, which would be long enough to determine whether or not the medication was working). Here's the record, it tells of updates and such: https://clinicaltrials.gov/archive/NCT02275351. 3. Phase 3's are larger than phase 2 with up to thousands of patients. 4. Their clinical trial page, was last updated at the end of march, so their recruitment status is valid. Why else would they be recruiting at 25 locations at this point in the trial unless they intended to go to phase 3?
> 
> I don't give a crap about things like follicept, that's like crack to someone on a hair loss forum, but I doubt it will work. Check out scientific journals related to the WNT pathway and hair growth, it tells A LOT.


 I think you can not make those conclusions just yet. If you check this thread 2 posters said they were starting with the trials in December. But one poster came forward at the end of January saying that he will start with trials soon. Meaning they were still recruiting for Phase 2 in February.

I would really like to see Phase 2 results as soon as possible. I mean I am waiting for Phase 2 results for Sm, CB and Bim. The sooner they get here the sooner we can move on if they don't work or get hyped up if they do.
Of course all that said if you are right then I will be happy and you can spam: "I TOLD YOU SO" as much as you want.

----------


## It's2014ComeOnAlready

> I think you can not make those conclusions just yet. If you check this thread 2 posters said they were starting with the trials in December. But one poster came forward at the end of January saying that he will start with trials soon. Meaning they were still recruiting for Phase 2 in February.
> 
> I would really like to see Phase 2 results as soon as possible. I mean I am waiting for Phase 2 results for Sm, CB and Bim. The sooner they get here the sooner we can move on if they don't work or get hyped up if they do.
> Of course all that said if you are right then I will be happy and you can spam: "I TOLD YOU SO" as much as you want.


 
Well, in regards to trial start dates, I'd rather go by what's on the clinical trials register (November), than what somebody says on the forum. My thoughts that they are recruiting for phase 3 come solely from what has been posted by Samumed. It can't be said for sure, but given how far along they are in their trial and that they are recruiting and added recruitments sites says something. The trial is over in September, and for a hair loss trial, approx 6 months is needed so hair can cycle. It would be quite disorganized, unprofessional, and unprepared of them to be recruiting for the same trial they are conducting while time is running out. I just don't see it. You need enough time for an effect to be seen, and then give yourself enough time to collect that data. According to clinicaltrials.gov, the primary outcome measure, and study completion are both in Sept., meaning everything with phase 2 will be done by then. 

In the meantime, I will taper the conclusions of my posts. I don't want to give anyone false hope, but I just personally like what I see. Believe me, I've read a tremendous amount about how clinical trials work, and the drugs that are being investigated for hair loss. I pay a lot of attention to this one because WNT pathway activity is directly related to hair cycling. When there is high WNT activity, it means the hair is in anagen. 

Lol I have no interest in telling anyone "I TOLD YOU SO," I just want something that has less sides, and more effective than what we have now. I also want people to be optimistic and happy. I think the science and current status of this drug are very encouraging, which is why I post.

----------


## ghostrider

Hello mates,

Who tried 6 bio? I read it's more potent


This article speaks about embryo cells
http://journals.plos.org/plosone/art...l.pone.0031502

It maintain embryo stemcells ? Aren't embryo stemcells similar to hair cells ?

Dr costs speak allot about wnt I guess it's key player in hairlosss

No wnt  amino acids equals hair

----------


## rdawg

> I would suspect they could not find enough participants at their existing sites and/or would rather open a new site than wait for new recruits.
> 
> These guys must have some deep pockets either way.


 They definitely started the trial, just probably wanted to add more people that would finish at a later date. 

I was invited to join the trial back in Feb, but obviously wasn't eligible due to FIN, which I imagine would eliminate alot of people who would have knowledge of it.

----------


## It's2014ComeOnAlready

I find it really hard to believe that they would be recruiting for a phase they're already in. What if you can't find participants in time, get them through months of treatment, enough so that all data can be measured in the end? It's quite risky to be recruiting while time is ticking, and millions of dollars are at stake. It would make a lot more sense to have all of your participants enrolled *before* the trial, so there aren't any issues like this.

----------


## rdawg

> I find it really hard to believe that they would be recruiting for a phase they're already in. What if you can't find participants in time, get them through months of treatment, enough so that all data can be measured in the end? It's quite risky to be recruiting while time is ticking, and millions of dollars are at stake. It would make a lot more sense to have all of your participants enrolled *before* the trial, so there aren't any issues like this.


 It's not that crazy

They may have started the trial completely in January, but with say 200-250 participants, and just added in the remaining the in the next two months, who will get slightly less time.

If I'm a company starting a trial, I'm not going to wait the extra 1-2 months for the remaining 50 or so participants to come in, I'll just go forward with the 200 or so and use the rest as extra data.

The same thing was happening with the CB trial as well, people claimed that had begun participating in that trial while it was still recruiting(i was invited to that one as well, it was the same clinic in minnesota as this one).

----------


## It's2014ComeOnAlready

> It's not that crazy
> 
> They may have started the trial completely in January, but with say 200-250 participants, and just added in the remaining the in the next two months, who will get slightly less time.
> 
> If I'm a company starting a trial, I'm not going to wait the extra 1-2 months for the remaining 50 or so participants to come in, I'll just go forward with the 200 or so and use the rest as extra data.
> 
> The same thing was happening with the CB trial as well, people claimed that had begun participating in that trial while it was still recruiting(i was invited to that one as well, it was the same clinic in minnesota as this one).


 Well, they're still recruiting with 5 months to go...cutting it kind close, no?  I might email a site to find out if they're still recruiting for phase 2.

----------


## Seuxin

> Hello mates,
> 
> Who tried 6 bio? I read it's more potent
> 
> 
> This article speaks about embryo cells
> http://journals.plos.org/plosone/art...l.pone.0031502
> 
> It maintain embryo stemcells ? Aren't embryo stemcells similar to hair cells ?
> ...


 
Not tried bu you can buy it at Kane !

----------


## It's2014ComeOnAlready

SM could really be the real deal. Setipiprant may not even be necessary if this turns out to be successful, or it would be a matter of topical vs oral medication.

Published in 2013, titled: "Tuning WNT Signals for More or Fewer Hairs" - http://www.nature.com/jid/journal/v1...d2012446a.html

"Abnormal hair development and regeneration has been implicated in diseases of the skin (e.g., hirsutism, alopecia) and in open wounds when hair follicles are eliminated completely. To manage these clinical conditions, it is important to understand molecular pathways that regulate the number, size, growth, and regeneration of hair follicles. Wnt signaling has a fundamental role in this process. We need a deeper understanding so that we can reliably adjust Wnt levels in existing follicles. In sum, the studies reviewed here have future translational value for skin regeneration following severe wound injury and in the context of tissue engineering. Tuning the levels of Wnt ligands can modulate the number and growth of hairs directly. On the basis of this new knowledge, we now know that Wnt activity can be modulated by adjusting the secretion of Wnt ligands, altering binding of ligands to receptors, inhibiting β-catenin translocation, or by regulating extrafollicular dermal Wnt and Wnt inhibitors."

----------


## champpy

I was also asked to come in and be evaluated as a candidate for CB trial at a clinic in Austin TX. This was only two months ago. The woman I spoke with mentioned that if I changed my mind and wanted to participate that I could get a hold of them later. I found this odd because I thought trials had "start dates", but apparently the CB trial has been ongoing and will continue to add people as time goes on

----------


## KO1

I assume that for trials, not everybody starts at the same date, so a six month trial may well take q year.

----------


## BiqqieSmalls

> I was also asked to come in and be evaluated as a candidate for CB trial at a clinic in Austin TX. This was only two months ago. The woman I spoke with mentioned that if I changed my mind and wanted to participate that I could get a hold of them later. I found this odd because I thought trials had "start dates", but apparently the CB trial has been ongoing and will continue to add people as time goes on


 This coincides with 2014's thoughts on Bim's recruiting process. 

Why wouldn't you participate in the CB trial?

----------


## It's2014ComeOnAlready

I'm just appreciative that companies with excellent backing are trying to tackle this problem from every known angle: WNT, PGD2, PGF2a, and chemicals with anti-androgenic properties without the side effects. 

One, if not all of these are bound to work.

----------


## burtandernie

Does anyone else find it odd what a coincidence it is that shortly after propecia went off patent that all these other things popped up?
Anyhow though I think the future for MPB in another 5 years will be different than it is now. It will be much easier to prevent and stop with much less risk

----------


## It's2014ComeOnAlready

> Does anyone else find it odd what a coincidence it is that shortly after propecia went off patent that all these other things popped up?


 Definitely not odd or a coincidence. It is the power of the almighty dollar.

----------


## BiqqieSmalls

> Definitely not odd or a coincidence. It is the power of the almighty dollar.


 How would Propecia's expired patent affect the occurrence of other products?

----------


## champpy

> This coincides with 2014's thoughts on Bim's recruiting process. 
> 
> Why wouldn't you participate in the CB trial?


 Well I live in Dallas and the trial is in Austin. Theres always the possibility that I might get the placebo and I don't want to make the 3 hr drive each month for a placebo.

I am also afraid that if I get the actual CB, and it works to retain my hair, what happens after I stop the 6 month treatment? Would my hairloss continue at an accelerated rate? I still have enough hair to cover the thinning areas. I cant afford to have it fall out even faster after discontinuing CB.

----------


## It's2014ComeOnAlready

> How would Propecia's expired patent affect the occurrence of other products?


 Means people could now buy generics, and none of that money goes to Merck. There is also no longer a brand name drug dominating the hair loss market, of which has only skimmed the surface. A new brand name drug that doesn't have sexual side effects and could potentially also used by women, would suck up most, if not all of the market. It would be a true slam-dunk in the pharma industry. Billions of dollars and untold potential.

----------


## KO1

Merck didn't make much money off fin.

----------


## Swooping

> Means people could now buy generics, and none of that money goes to Merck. There is also no longer a brand name drug dominating the hair loss market, of which has only skimmed the surface. A new brand name drug that doesn't have sexual side effects and could potentially also used by women, would suck up most, if not all of the market. It would be a true slam-dunk in the pharma industry. Billions of dollars and untold potential.


 Mwah, I think you heavily overvalue the market for androgenetic alopecia. For comparison the glaucoma market is almost twice as big. I won't even speak how big the market is for other segments but it's way way more than AGA. 

Like KO1 stated finasteride financially wise was a pretty bummer for Merck too.

----------


## Parsia

> Well I live in Dallas and the trial is in Austin. Theres always the possibility that I might get the placebo and I don't want to make the 3 hr drive each month for a placebo.
> 
> I am also afraid that if I get the actual CB, and it works to retain my hair, what happens after I stop the 6 month treatment? Would my hairloss continue at an accelerated rate? I still have enough hair to cover the thinning areas. I cant afford to have it fall out even faster after discontinuing CB.


 Oh Really ? Is that In Austin ? I didn't know that , I live in Dallas too , I really interested to go and try it , if you want I can be your partner to go there every month and get the trail . Hope we don't get placebo . You can come with my car if you like to.

----------


## It's2014ComeOnAlready

> Mwah, I think you heavily overvalue the market for androgenetic alopecia. For comparison the glaucoma market is almost twice as big. I won't even speak how big the market is for other segments but it's way way more than AGA. 
> 
> Like KO1 stated finasteride financially wise was a pretty bummer for Merck too.


 Yea, which is why I said finasteride only skimmed the surface of the hair loss market. If there were  a drug with far less side effects, and can be used universally, it would be bigger than glaucoma. Nobody wants to be bald, or have their hair thin out. You are underestimating the market potential of a better drug than fin.

----------


## It's2014ComeOnAlready

> Merck didn't make much money off fin.


 Oh, KO1. Always there to try and correct me, but can't because he incorrectly reads my posts. If you look a little closer, I said fin skimmed the surface of the hair loss market. Also, Merck has made billions off of fin over the years btw. Maybe not every year, but billions no doubt.

----------


## It's2014ComeOnAlready

Clinical trial page has been updated again, is still recruiting patients in all 25 locations, and some are not yet recruiting. There are 4 months to go in this trial.

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## champpy

Parsia,
I don't know man, im still worried about what happens if we get the drug for 6 months then stop. But the offer is tempting. Ive tried to contact the clinic again to ask about this issue but I haven't heard back from them yet. Ill keep you posted as soon as I hear back from them

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## KO1

> Oh, KO1. Always there to try and correct me, but can't because he incorrectly reads my posts. If you look a little closer, I said fin skimmed the surface of the hair loss market. Also, Merck has made billions off of fin over the years btw. Maybe not every year, but billions no doubt.


 How much have they made?

----------


## It's2014ComeOnAlready

> How much have they made?


 You can look that up and get back to me. 1997-2013/14

----------


## It's2014ComeOnAlready

Good Find: That accidental "breakthrough" study that came out of Spain in December (some of you may recall) helps make the case for SM04554 all the more intriguing. Here it is: http://journals.plos.org/plosbiology...bio.1002002#s3

It's entitled: "Macrophages Contribute to the Cyclic Activation of Adult Hair Follicle Stem Cells"

Some good parts: "Our study delineates that macrophage-derived Wnts activate HF-SCs and HF entry into anagen...Determining whether these molecular signals are orchestrated along with the intrinsic HF-SC regulatory cues will be valuable to define the multiple hierarchies that underlie HF regeneration. Once powerful tools of molecular biology at hand in mice become applicable to human hair research, including novel in situ-imaging tools to assess HF-SC activation in humans, new translationally and therapeutically relevant insights into the macrophage-epithelial SC connection and its role in tissue remodeling, organ repair, and hair diseases may be achievable."

Let's hope they have the right compound/delivery to do what is intended.

----------


## It's2014ComeOnAlready

Just felt like posting something about the trials, in case people missed something. 

They used 3 different formulations for their phase 1 testing: 0.05%, 0.15%, and 0.45%. Participants were required to use the medication for 14 days. Anagen entry takes 7-9 days. 14 days after use (28 days since start), all hair-related measurements etc were taken. 

In the phase 2 study, they recruited 300 participants, the maximum allowed for phase 2. They're also only testing at 0.15% and 0.25%. 0.45% and 0.05% were dropped, presumably because they found the most effective/safest range. The good news is, that they most likely saw an effect, because they decided not only to go through with phase 2 studies, limited the concentration range for effectiveness and safety, but they also recruited the largest group possible, at the highest cost. 

We all (hopefully) now know how crucial the WNT pathway is to hair follicle formulation and cycling, so if this drug enters phase 3, get VERY excited. If anyone has any qualms about this company, keep in mind they are experts in the WNT pathway, and drugs that effect the WNT pathway. They're also trailing drugs for more serious conditions like cancer and osteoarthritis that are also WNT related. Pfizer has various agreements with this company, and have their own people working with them in R&D.

----------


## Keki

The first product which goes to phase 3 is our next treatment, no doubt about that, i have a good feeling about CB and SM, we could replace propecia in a couple of years

----------


## It's2014ComeOnAlready

I wonder, if this drug makes it to phase 3, could they have a quicker trial than usual? The medication is only used for 90 days, and they have 300 previously recruited participants. Why not trial them altogether to quicken the process? 

Hopefully SM makes it there. They just finished getting all their 300 recruits for phase 2, and have pushed the end of the trial another month to October.

----------


## runrunrun

I always read your article cafefully. Thanks 2014  :Smile:  Are they(SM, CB, BIM and Replicel)feasible?? I do not want to believe fake hope any more....

----------


## It's2014ComeOnAlready

> I always read your article cafefully. Thanks 2014  Are they(SM, CB, BIM and Replicel)feasible?? I do not want to believe fake hope any more....


 Hey runrunrun, they are all feasible in their own way, all different approaches, too. SM and CB are in phase 2, and we'll know in the fall if they'll proceed to phase 3. If they do, then they will almost certainly enter the market after. For those two different approaches, it should be about 2 more years till market because they will need to get through phase 3 (approx 1 year), and then FDA approval (approx 10 months).

Bimatoprost definitely works on hair, we just don't know the results of their last trial. Hopefully the results were good enough to have them move forward, but things have been very secretive since there are legal issues with other companies making the same drug. If they've continued trials, then we should see BIM sometime in late fall or winter. They haven't updated their clinical trial page to say if they're going with a phase 3, but like I said, they could be hiding the results and maybe their current testing. Hard to know for sure, but we should find out the results of phase 2b sometime during late summer. Keep your fingers crossed.

As for Replicel, this looks like a really good treatment, and Shiseido has thrown a lot of money and research into it. They have their own shiny, new facility in Japan dedicated to this alone. Because of Japan's fast track process, they expect this will be available in Japan by 2018. So, if you have a good amount of money saved up, you could fly to Japan and have this done. 

There's also Kythera's Setipiprant, which should prove very effective. That's the PGD2 hypothesis driven by Dr. Cotsarelis from UPenn. That particular drug should become available in 3-4 years.

So, there are a lot of upcoming options and new effective treatments in the very near future. All of these have a lot of research behind them. No current hair loss drug was the result of research or science, they occurred by accident. Other angles have been figured out (WNT, PGD2, PGF2a, side effect-free topical anti-androgens, cellular replacement), and are now being trialled. Nothing will come tmr or a few months from now, but there should be a lot to smile about in the next few years.

----------


## brocktherock

> Hey runrunrun, they are all feasible in their own way, all different approaches, too. SM and CB are in phase 2, and we'll know in the fall if they'll proceed to phase 3. If they do, then they will almost certainly enter the market after. For those two different approaches, it should be about 2 more years till market because they will need to get through phase 3 (approx 1 year), and then FDA approval (approx 10 months).
> 
> Bimatoprost definitely works on hair, we just don't know the results of their last trial. Hopefully the results were good enough to have them move forward, but things have been very secretive since there are legal issues with other companies making the same drug. If they've continued trials, then we should see BIM sometime in late fall or winter. They haven't updated their clinical trial page to say if they're going with a phase 3, but like I said, they could be hiding the results and maybe their current testing. Hard to know for sure, but we should find out the results of phase 2b sometime during late summer. Keep your fingers crossed.
> 
> As for Replicel, this looks like a really good treatment, and Shiseido has thrown a lot of money and research into it. They have their own shiny, new facility in Japan dedicated to this alone. Because of Japan's fast track process, they expect this will be available in Japan by 2018. So, if you have a good amount of money saved up, you could fly to Japan and have this done. 
> 
> There's also Kythera's Setipiprant, which should prove very effective. That's the PGD2 hypothesis driven by Dr. Cotsarelis from UPenn. That particular drug should become available in 3-4 years.
> 
> So, there are a lot of upcoming options and new effective treatments in the very near future. All of these have a lot of research behind them. No current hair loss drug was the result of research or science, they occurred by accident. Other angles have been figured out (WNT, PGD2, PGF2a, side effect-free topical anti-androgens, cellular replacement), and are now being trialled. Nothing will come tmr or a few months from now, but there should be a lot to smile about in the next few years.


  Its good to see someone has both does their homework and is on here with the intent to help people.

----------


## runrunrun

Thank you for your kindness!!

----------


## GSD

wrong post...delete pls

----------


## KO1

Cots and Samumed need to put their noodles together.

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## cr1mson

> Its good to see someone has both does their homework and is on here with the intent to help people.


 +1 always appreciate your posts. Good to see veterans keeping it unbiased and helping newbies out.

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## It's2014ComeOnAlready

btw i read in a recent article that Samumed is expanding its own facilities by almost 19,000 sq ft. The company is doing well.

----------


## Sogeking

> +1 always appreciate your posts. Good to see veterans keeping it unbiased and helping newbies out.


 Trust me mate, no one likes to be a veteran here  :Big Grin:   :Big Grin: .
As for Samumed as It's2014 has already noted:



> Samumed, a biopharmaceutical research company, received a $2.1 million tax credit because of its promise to invest $30.5 million in facilities and expansion. It must hire 273 new workers at an average salary of $85,000 by 2019.


 So financially they have money. I just want to see their Phase 2 results. 
There were some Phase 3 drugs that were pulled out from testing by their respective companies in the past. It is usually done because of the lack of effectiveness. If they show good Phase 2 results we can all get hyped.

----------


## It's2014ComeOnAlready

haha that's 100% correct, nobody wants to be a vet on here. I wish BTT wasn't at all necessary, but we're all so desperate for new and better treatments. It's really the fault of doctors, scientists, and companies. Luckily, there are a number of things coming soon, but the waiting really sucks.

----------


## KO1

Where are they going to get the $30M from? Don't say Pfizer, Pfizer has a stake in the firm as they were incubated by them and SM was found in Pfizer's chemical library, but that doesn't mean that Pf will be investing more. They will need to raise via VC presumably.

----------


## It's2014ComeOnAlready

> Where are they going to get the $30M from? Don't say Pfizer, Pfizer has a stake in the firm as they were incubated by them and SM was found in Pfizer's chemical library, but that doesn't mean that Pf will be investing more. They will need to raise via VC presumably.


 I have no idea where they're getting the money from, but they have enough to expand by nearly 19,000 sq feet and 273 new full time employees. They seem to have plenty on their own without pfizer.

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## KO1

No, they have promised to expand and hire that many people....they have not actually done this yet. Let's wait and see.

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## It's2014ComeOnAlready

Well, to be clear, they've already leased the the 19,000 sq ft. space. They also have already received the $2.1 million tax credit from California State Gov't for a promise to hire those workers. If they don't fulfill that promise, they're probably going to be in some legal trouble.

----------


## Hemo

> Well, to be clear, they've already leased the the 19,000 sq ft. space. They also have already received the $2.1 million tax credit from California State Gov't for a promise to hire those workers. If they don't fulfill that promise, they're probably going to be in some legal trouble.


 Eh, possibly.  Many companies have received subsidies or won government bids and not completely fulfilled their end of the bargain, with no legal repercussions.  Not saying that will happen here but it certainly wouldn't be the first time.

----------


## It's2014ComeOnAlready

Hey y'all, pretty random but I came across a comment about SM04554 on hairlosscure2020.com and someone who posted as "anonymous" said: "I am in the current study and am very encouraged!" 

He obviously couldn't say more than that because of the non-disclosure agreement, but hopefully it means he's seen some results. 

btw hairlosscure2020 is a very good site to keep up with things. I recommend it.

----------


## FearTheLoss

Yeah, I hope you're right 2014...but realistically it's probably one of these sick trolls trying to mess with people as usual. How they find pleasure in this, I do not know.

----------


## It's2014ComeOnAlready

> Yeah, I hope you're right 2014...but realistically it's probably one of these sick trolls trying to mess with people as usual. How they find pleasure in this, I do not know.


 Eh, well usually *trolls* might say something more along the lines of "I'm in this trial and it's not working at all. I've used it for a month and seen nothing. Guess nothing will ever work"  

This was pretty vague, but hints at it being good. All with the user name being "anonymous." Also, I think a sick troll might take more pleasure in turning things negative to put people off. It's just sadism. I know that if I was part of the trial, I wouldn't want to get kicked for breaking the NDA, if the meds were working. 

Lots of top US derms are part of trials for this one. Wilma Bergfeld, who is co-chair with Christiano for the hair congress is involved. Perhaps he is very encouraged by what one of the docs told him, or he has been using it and seeing results. Hard to tell, because they just finished their last round of recruitment on May 26th, but I think it's genuine.

----------


## FearTheLoss

> Eh, well usually *trolls* might say something more along the lines of "I'm in this trial and it's not working at all. I've used it for a month and seen nothing. Guess nothing will ever work"  
> 
> This was pretty vague, but hints at it being good. All with the user name being "anonymous." Also, I think a sick troll might take more pleasure in turning things negative to put people off. It's just sadism. I know that if I was part of the trial, I wouldn't want to get kicked for breaking the NDA, if the meds were working. 
> 
> Lots of top US derms are part of trials for this one. Wilma Bergfeld, who is co-chair with Christiano for the hair congress is involved. Perhaps he is very encouraged by what one of the docs told him, or he has been using it and seeing results. Hard to tell, because they just finished their last round of recruitment on May 26th, but I think it's genuine.


 

I hope you're right!

----------


## It's2014ComeOnAlready

> I hope you're right!


 Believe!!! lol

----------


## nameless

> Eh, well usually *trolls* might say something more along the lines of "I'm in this trial and it's not working at all. I've used it for a month and seen nothing. Guess nothing will ever work"  
> 
> This was pretty vague, but hints at it being good. All with the user name being "anonymous." Also, I think a sick troll might take more pleasure in turning things negative to put people off. It's just sadism. I know that if I was part of the trial, I wouldn't want to get kicked for breaking the NDA, if the meds were working. 
> 
> Lots of top US derms are part of trials for this one. Wilma Bergfeld, who is co-chair with Christiano for the hair congress is involved. Perhaps he is very encouraged by what one of the docs told him, or he has been using it and seeing results. Hard to tell, because they just finished their last round of recruitment on May 26th, but I think it's genuine.


 What could he possibly know already? Not much. He probably just heard a lot of good things about if from the staff involved with the study.

----------


## Illusion

TBF someone who goes online and says "I'm in the SM trial and it doesn't do jack sh!t" can still be right as he might have gotten placebo instead of the real deal. So in that case you wouldn't be able to tell if someone's trolling or just being serious.

----------


## Dimoxynil

> TBF someone who goes online and says "I'm in the SM trial and it doesn't do jack sh!t" can still be right as he might have gotten placebo instead of the real deal. So in that case you wouldn't be able to tell if someone's trolling or just being serious.


 Sensible comment

----------


## It's2014ComeOnAlready

> TBF someone who goes online and says "I'm in the SM trial and it doesn't do jack sh!t" can still be right as he might have gotten placebo instead of the real deal. So in that case you wouldn't be able to tell if someone's trolling or just being serious.


 Yeah, but my point is that trolling is done to make people feel bad. How is it trolling to say you're very encouraged by something, especially if it's vague enough to avoid breaking an NDA?

----------


## It's2014ComeOnAlready

> What could he possibly know already? Not much. He probably just heard a lot of good things about if from the staff involved with the study.


 Well, he's possibly in the last round of recruits, who were last rounded up on May 26th. His comment was on May 31st. It's possible that word had gotten around amongst the clinics trialling this drug that they'd seen good results in previous rounds of recruitment, and he was very encouraged by what the docs have told him.

----------


## nameless

> Yeah, but my point is that trolling is done to make people feel bad. How is it trolling to say you're very encouraged by something, especially if it's vague enough to avoid breaking an NDA?


 The poster did not say that he saw regrowth on anyone. He simply said he's encouraged. That could easily mean he feels positive about the treatment based on his view of the science involved or he could feel encouraged because of some pep talk given to him by the clinical trial staff.

----------


## TooMuchHairWontKillYou

How long will it take SM to come to market if everything goes well?

----------


## It's2014ComeOnAlready

> How long will it take SM to come to market if everything goes well?


 2 yrs - 1 more year for phase 3, 10 months for FDA approval.

----------


## TooMuchHairWontKillYou

> 2 yrs - 1 more year for phase 3, 10 months for FDA approval.


 Nice, Thanks! SM is my biggest hope after Replicel  :Smile:

----------


## Illusion

Could be longer though, just prepare for waiting a good amount of time

----------


## It's2014ComeOnAlready

> Could be longer though, just prepare for waiting a good amount of time


 Uhh I think we're set with the 2 years, thanks.

----------


## Illusion

> Yeah, but my point is that trolling is done to make people feel bad. How is it trolling to say you're very encouraged by something, especially if it's vague enough to avoid breaking an NDA?


 Yeah I know, wasn't directly aimed at you. It was more of a throwaway comment because there was some discussion about trolling in general going on.




> Uhh I think we're set with the 2 years, thanks.


 I'll pinpoint it on my calender

----------


## burtandernie

I can understand 2 years for something like this, but CB is an AA. There are lots of AAs so there is already some good evidence for how they work. Does CB need 2 years to prove its safe? Just seems something like that could go faster given the smaller risks with that compared to say this or other new approaches.

----------


## It's2014ComeOnAlready

> The poster did not say that he saw regrowth on anyone. He simply said he's encouraged. *That could easily mean he feels positive about the treatment based on his view of the science involved or he could feel encouraged because of some pep talk given to him by the clinical trial staff*.


 Yeah, which is why I included in the post before that this is the last round of recruits. Each participant takes this medication for 90 days, with a follow up one month later. The trial is 11th months long, they stopped recruiting on May 26th, and the trial is over in October. At this point in the study, they'd have a pretty good idea of whether this drug works or not to some degree. He could have been very encouraged by the clinical trial staff, but based on the knowledge of the effect it had on previous participants.

Where did I say he saw regrowth?

----------


## nameless

> Yeah, which is why I included in the post before that this is the last round of recruits. Each participant takes this medication for 90 days, with a follow up one month later. The trial is 11th months long, they stopped recruiting on May 26th, and the trial is over in October. At this point in the study, they'd have a pretty good idea of whether this drug works or not to some degree. He could have been very encouraged by the clinical trial staff, but based on the knowledge of the effect it had on previous participants.
> 
> Where did I say he saw regrowth?


 Can you show me where I said that you said that he saw regrowth? I never said you said that. I simply pointed out that his encouragement might have nothing to do with seeing hair growth and his encouragement might simply be because of his intuition about the science involved or positive remarks he heard from clinical staff. 

Also, I think that the poster is probably not a troll because his post does not sound like something a troll would say. I think he's probably in the study.

----------


## nameless

> Hello all, new to the board here. 
> 
> Start this trial today (USA). The doctor is extremely encouraged by the potential of this treatment, although the clinical research nurse with whom I spoke said she hasn't witnessed much growth in the patients she has seen thus far.
> 
> We shall see.


 
This does not sound good at all.

----------


## TooMuchHairWontKillYou

is it possible to skip phase 3 somehow? :\

----------


## It's2014ComeOnAlready

> is it possible to skip phase 3 somehow? :\


 Unfortunately, no.

----------


## joachim

> is it possible to skip phase 3 somehow? :\


 only in japan.

----------


## Illusion

> 2 yrs - 1 more year for phase 3, 10 months for FDA approval.


 I just thought about this, you mean 2yrs from when phase 2 has ended right? So we would need to add up a couple of months (4 months? maybe we can round it up to half a year to err on the safe side) to that number because phase 2 isn't finished yet, right? It sucks that transitions between phases always seem to go so slow but then again, this is if all goes well. Maybe 2,5 yrs could be a decent guesstimate.

Btw, why is it that there's so little information about SM online? I can only find facts about trials, the only background article I could find was the one one hairlosscure2020, from Oct. 2014. I'm sure this has been brought up before but I just don't get it, normally there's always _someone_ hyping up new potentional hair loss treatments, be it the daily news (lol) or an actual reputable source. But nothing this time, even though phase 2 is already rolling...

----------


## It's2014ComeOnAlready

> I just thought about this, you mean 2yrs from when phase 2 has ended right? So we would need to add up a couple of months (4 months? maybe we can round it up to half a year to err on the safe side) to that number because phase 2 isn't finished yet, right? It sucks that transitions between phases always seem to go so slow but then again, this is if all goes well. Maybe 2,5 yrs could be a decent guesstimate.
> 
> Btw, why is it that there's so little information about SM online? I can only find facts about trials, the only background article I could find was the one one hairlosscure2020, from Oct. 2014. I'm sure this has been brought up before but I just don't get it, normally there's always _someone_ hyping up new potentional hair loss treatments, be it the daily news (lol) or an actual reputable source. But nothing this time, even though phase 2 is already rolling...


 About the timeline - Samumed has launched each trial in quick succession. Also, they have 24 recruiting locations, and 300 participants already, so if it's successful in phase 2, they could immediately gear up for phase 3. Phase 2 was originally 10 months, but was recently extended to 11 months because of recruiting. As for FDA approval, 10 months is the maximum amount of time, it could be approved sooner. You're quibbling about a few months here and there, you say 2.5, I say 2. I don't care. If this drug is successful, they will want to get it to market ASAP. 

SM is actually a drug that was discovered by Samumed in Pfizer's chemical library, because of it's WNT-activating ability. Pfizer and Samumed have some sort of agreement of the development of drugs, and even have some of their own people working in R&D with Samumed. 

As noted by nameless in a different thread, phase 1 was safety and lasted for 14 days of use. Anagen entry take 7-9 days, and they definitely took scalp biopsies after use. If they saw dormant follicles entering anagen, they'd be popping champagne corks. I'd keep it quiet until there was a chance to further develop the drug, if that's what they saw. It's possible they did, because they immediately launched a massive phase 2, immediately after phase 1. We've gotten a little bit of information about the trial from participants, and they all said that the doctors conduction the trial are very excited, and encouraged about this drug.


If you want an idea about what SM aims to do, have a look at this journal - http://www.nature.com/jid/journal/v1...d2012446a.html

and this press release - http://www.uphs.upenn.edu/news/News_...013/12/millar/

----------


## Illusion

Thanks 2014, very constructive post. Interesting links as well.

Btw, no hard feelings about the discussion regarding how long it will take from now to commercialisation mate

----------


## Marconi SK

can we try it?

http://www.chemicalregister.com/SM04...pid1646971.htm

----------


## It's2014ComeOnAlready

> we can try it?
> 
> http://www.chemicalregister.com/SM04...pid1646971.htm


 Bad idea.

No way to tell if that's even the real drug. Plus, if used improperly or at too high a concentration, there holds the risk of cancer.

----------


## Illusion

Would be interesting to see for how much it is being sold on black (?) market though. It's prob not a good indication for the price of when this comes out, but still.

On the other hand, it doesn't really matter to me if this is going to be expensive or not. Hell, even if this will cost me $100/month, I'll still buy it if the results are good.

----------


## It's2014ComeOnAlready

> Would be interesting to see for how much it is being sold on black (?) market though. It's prob not a good indication for the price of when this comes out, but still.
> 
> On the other hand, it doesn't really matter to me if this is going to be expensive or not. Hell, even if this will cost me $100/month, I'll still buy it if the results are good.


 There's no way to tell what the actual drug is. They call it SM04554, but that's the name Samumed gave it. The compound itself is unknown.

----------


## nameless

> Hello all, new to the board here. 
> 
> Start this trial today (USA). The doctor is extremely encouraged by the potential of this treatment, although the clinical research nurse with whom I spoke said she hasn't witnessed much growth in the patients she has seen thus far.
> 
> We shall see.


 
This patient posted this on 1/29/15. This is very bad news because this phase 2 study was well under way when he posted this and that means that the clinical nurse he referred to would have seen numerous patients by then and if the product was working she would have seen patients with regrowth by then. I think this is indicative that the treatment probably doesn't work or at least it doesn't work very well.

----------


## TooMuchHairWontKillYou

> This patient posted this on 1/29/15. This is very bad news because this phase 2 study was well under way when he posted this and that means that the clinical nurse he referred to would have seen numerous patients by then and if the product was working she would have seen patients with regrowth by then. I think this is indicative that the treatment probably doesn't work or at least it doesn't work very well.


 Then why they recruited 300 participants? I don't understand. if you see no results with 100 why add 200 more?

----------


## bigentries

> Then why they recruited 300 participants? I don't understand. if you see no results with 100 why add 200 more?


 Ask the same to Aderans

They also expanded their trial, injected more money, split the original treatment into several Ji Gami formulas. Still went nowhere

----------


## It's2014ComeOnAlready

> This patient posted this on 1/29/15. This is very bad news because this phase 2 study was well under way when he posted this and that means that the clinical nurse he referred to would have seen numerous patients by then and if the product was working she would have seen patients with regrowth by then. I think this is indicative that the treatment probably doesn't work or at least it doesn't work very well.


 Wow. Confirmation bias much?

This really doesn't tell us anything.

----------


## Hemo

> This patient posted this on 1/29/15. This is very bad news because this phase 2 study was well under way when he posted this and that means that the clinical nurse he referred to would have seen numerous patients by then and if the product was working she would have seen patients with regrowth by then. I think this is indicative that the treatment probably doesn't work or at least it doesn't work very well.


 Yeah, or it's a troll.  I'm sure nurses are just throwing this type of information out there to anyone that asks, even though it could be detrimental to the study.  I realize it would only take one to mess up, but I'm also not going to ignore a potential treatment because a random user says it isn't working.

----------


## It's2014ComeOnAlready

> Ask the same to Aderans
> 
> They also expanded their trial, injected more money, split the original treatment into several Ji Gami formulas. Still went nowhere


 lol yea to you, everything's an Aderans. This has nothing to do with Aderans.

----------


## bigentries

> lol yea to you, everything's an Aderans. This has nothing to do with Aderans.


 Or Intercytex, or Histogen, etc.

You haven't even been a full year here and look at your post count!

You should curb your enthusiasm a little bit, you keep trying to inject naive optimism to every treatment that has been announced in the last year. 

Better read a little bit, there is more than a decade of information available on hair loss forums. You can see how many like you have come and go and we still don't have a treatment available

----------


## It's2014ComeOnAlready

> Or Intercytex, or Histogen, etc.
> 
> You haven't even been a full year here and look at your post count!
> 
> You should curb your enthusiasm a little bit, you keep trying to inject naive optimism to every treatment that has been announced in the last year. 
> 
> Better read a little bit, there is more than a decade of information available on hair loss forums. You can see how many like you have come and go and we still don't have a treatment available


 Ok your posts defy logic on many levels. I'd take the time to pick it apart, but it's clear you're stuck having a big ego on a hair loss forum. 

Don't reply to any of my posts, I don't care what you have to say. Neither should anyone else.

----------


## bigentries

> Ok your posts defy logic on many levels. I'd take the time to pick it apart, but it's clear you're stuck having a big ego on a hair loss forum. 
> 
> Don't reply to any of my posts, I don't care what you have to say. Neither should anyone else.


 I'll continue replying to your posts, it's a discussion forum. If you don't like discussion go open a blog with closed comments

----------


## nameless

http://journals.plos.org/plosone/art...l.pone.0129578

One thing - can someone please tell me what telogenic mice are?

----------


## It's2014ComeOnAlready

> http://journals.plos.org/plosone/art...l.pone.0129578
> 
> One thing - can someone please tell me what telogenic mice are?


 Sounds like mice they've altered so their hair is in a telogen state, as opposed to the normal hair growth cycle, so that they may test their hypothesis with a drug, treatment etc. 

Remember when Cotsarelis induced AGA into mice by overexpressing Cox-2? That was in part how he developed his PGD2 hypothesis.

----------


## Tenma

I think we all have to wait for phase 2 to finish before getting too excited.

If results are disclosed or phase 3 confirmed, then i will be happy as hell

Its a good sign they are planning to expand their facilities though

----------


## Keki

Don't trust any mouse study guys

----------


## nameless

One thing that bothers me about the SM05445 concept is that more and more the dermatological community is saying that growth factors mediate hair growth downstream from the anti-androgen pathway, but if that's true then it seems like SM05445 would have to be continuously applied the same as anti-androgens have to be continuously applied. I mean if they work on the same pathway. 

If anti-androgens have to be continuously applied in order to keep the bald genie in check then any treatment that works downstream on the same path should also have to be applied continuously.

----------


## trunks

Indeed, sadly MPB is chronic condition and requires lifelong treatment. The ultimate solution would be shutting down our Androgen Receptors. Why we are balding in such a pattern - Fron NW1-NW7? Beacuse of the density of ARs on our scalp

LINK




> "The higher levels of androgen receptors in cells from balding scalp hair follicles with similar properties to those from non-balding scalp concur with the expectations from their in vivo responses to androgens."


 So, do we have impaired Androgen Receptors? The answer is yes.

LINK




> In summary, our findings represent the first association between a candidate gene and MPB. We suggest that abnormality of the AR gene is necessary, but not sufficient for the phenotype. We envisage a polygenic inheritance, dependent on a combination of a mutation in or around AR affecting the expression of the androgen receptor and genes controlling androgen levels. Interactions between such genes might account for the tissue-specific and developmental stage-specific expression of AR that is necessary to explain the characteristic anatomic and temporal patterns of MPB.


 As stated in the study above, mutation of AR gene is not enough for MPB to come in full glory. DHT binds to the AR receptor, RU58841 binds too - blocking DHT. Shouldnt it be full cure(with Fin and Dut)? Sadly It is not. 

Lets find out other factors. But hey, what about the fact that women dont go bald even with balding gene? Some of them have got all of our AR mutations and even more ARs on scalp.

LINKl




> Both women and men with androgenetic alopecia have higher levels of androgen receptors and 5-reductase type 1 and 2 in frontal than in occipital hair follicles, whereas higher levels of aromatase were found in their occipital follicles (Sawaya and Price, 1997). Aromatase content in women's frontal hair follicles was six times greater than in frontal hair follicles in men. Frontal hair follicles in women had 3 and 3.5 times less 5-reductase type 1 and 2, respectively, than frontal hair follicles in men (Sawaya and Price, 1997)."


 It strongly suggests that DHT is the only one to blame. The onset of AGA, the castration results - everything is connected with DHT! 

Now back to the SM04554 topic

LINK

Androgens are inhibiting Wnt/B-catenin pathaway - which is crucial for hair loss cycle




> These results suggest that Wnt signaling in DP cells is regulated by androgen and this regulation plays a pivotal role in androgen’s action on hair growth


 Telogen cell arest - sounds familiar?

http://www.nature.com/jid/journal/v1...id201343a.html





> This study identified four AGA risk loci with genome-wide significance on chromosomes 2q35, chr3q25, chr5q33.3, and chr12p12.1, and provides biological evidence that WNT10A is the gene responsible for the effect on chr2q35.


 


> In particular, some authors have suggested that WNT signaling constitutes an important regulatory signal for the transition from telogen to anagen in postnatal hair follicles (Reddy et al., 2001; Li et al., 2011). Interestingly, WNT10A expression has been detected at anagen onset in mouse hair follicles (Reddy et al., 2001), suggesting that WNT10A is implicated in


 We ve go impaired Wnt10A genes. It seems that AGA is poligenic disease. We need DHT blocker for sure but we also need Wnt agonist! Thats why I strongly believe in SM04554 there is a lot of science behind it. Wnt pathaway is crucial for Anagen onset. Without this mechanism Antiandrogens are almost useless. 


So, SM04554 with DHT inhibiotor would be a cure? In theory, yes.

----------


## trunks

Interesting article about Wnt and wounding




> Generating New Hair 
> 
> How stem cells can help hair re-grow after wounding 
> 
> Look at one of your scars. You'll notice some differences between a scar and the skin around it. For one, the scar isn't as stretchy as the skin. And it doesn't have any hair. 
> 
> Wouldn't it be great if scientists knew how to make scars less scar-like? Well, they have taken the first step in mice. 
> 
> What scientists have done is to begin to figure out how to grow hair where a scar forms. And when head scars leave bald spots being able to re-grow hair becomes pretty important. Just ask my sister. 
> ...

----------


## nameless

1. Anti-androgens need to be applied permanently.

2. Let's *assume* anti-androgens grow hair by way of stimulating Wnt. 

3. This would mean that the reason you lose hair when you cease anti-androgen treatment is because you stopped taking the anti-androgen that was stimulating Wnt for you. 

4. Since the anti-androgen has to be used permanently this seems to mean that Wnts also have to be stimulated permanently or else you could quit the anti-androgen without losing your new hair.

I'm basing all of this on the idea that anti-androgens reverse hair loss by stimulating Wnts. 

If anti-androgens regrow lost hair is by stimulating Wnts then it seems to me that this would mean that follicles need permanent Wnt stimulation in order to regrow lost hair or else the follicles wouldn't need permanent anti-androgen therapy in order to regrow lost hair. 

If this is all true then I don't see how SM0554 can work after its' discontinued and they're only applying it a few months in the study.

----------


## burtandernie

Your not going to use SM and just be cured your going to be using it for life instead of propecia most likely. Its funny because Merck tried that type 1 DHT inhitibitor which didnt seem to do that much for hair but of course propecia did. Odd because type 1 is supposedly even more abundant local to hair. Seems dut would stop MPB for almost everyone but it doesnt.
I agree with all your receptor stuff and the WNT pathway having huge potential. My biggest worry is no one knows how far down the rabbit hole goes. There could 20 different factors layered under the WNT pathway or tied into a combination of both. There is no limit to how complicated it could get and that would take our life time to unravel.

----------


## lacazette

They will finish phase ll in october 2015.

Do you think Samumed is interested in a partnership with a japan company like replicel?

With new japan's laws, they could have an approval market there after just their phase 2 results! They could make money and continue their phase 3 for a worldwide approval.

Since a lot of companies ( not only hairloss) are already planning to do this for all the advantages, I wonder why Samumed could not be interested in every points? no?

If this could be true, we could have a daily Wnt topic  before 2016!!

Maybe if a lot of people in all hair loss forums contact Samumed about japan drug approval idea, they will see that they could do benefits really quickly and continue their FDA approval with already money in the Pocket. Aren't you agree guys?

----------


## Arieux

@lacazette: it would be fantastic for us if Setipiprant was in asian market in this way without phase 3! However, I don't know if Samumed would be interested in a partnership with company like Replicel. This technology constitues the biggest competition to any of antiandrogens. Drugs have to be taken all the time and Replicel would be a permanent solution, as they said:  




> you no longer have cells that are affected by androgen running in your hair follicle on top of your head. So that is a permanent solution. It’s not like you’re taking a drug, which basically juices the performance of what cells are left, but it doesn’t actually change the inevitable outcome. We’re changing, we’re going to reverse and change the inevitable outcome, so those hair follicles no longer are compromised by androgen.


  (source: http://www.midasletter.com/2014/10/r...rview-podcast/ ).

So if someone can afford to fly to Japan in 2018 and take this set of injenctions, he won't be more interested in holding his hair. The only thing he may want to do is to ,,repair'' lost hair by HT. Of course, it is true supposing that Replicel will work exactly as they say. It is my biggest dream: to wake up one day and don't have to think about my worsening hair situation...

----------


## FearTheLoss

> They will finish phase ll in october 2015.
> 
> Do you think Samumed is interested in a partnership with a japan company like replicel?
> 
> With new japan's laws, they could have an approval market there after just their phase 2 results! They could make money and continue their phase 3 for a worldwide approval.
> 
> Since a lot of companies ( not only hairloss) are already planning to do this for all the advantages, I wonder why Samumed could not be interested in every points? no?
> 
> If this could be true, we could have a daily Wnt topic  before 2016!!
> ...


 

This couldn't be more false, first of all Replicel is a Canadian company, they partnered with Shiseido, which is a Japanese company. Second of all, the Japanese rules don't apply to drugs. Third of all, having the forum contact Samumed will do nothing, because they legally can't do it. Lastly, these guys know what they are doing and don't need any of us here to help, to think that they don't know regulations of different areas around he globe is misinformed.

----------


## lacazette

"the Japanese rules don't apply to drugs"

I'm not sure of what you claim when I see exemple like this: 

ZURICH—Swiss pharmaceutical company Novartis AG said Friday that it won approval in Japan for a new psoriasis drug, the first country to give the treatment a green light for commercialization.


You can google it, and you'll see that it's not the only drug who got a first approval in japan,  so I'm sure the process is short there, ( not difficult when you compared to fda)

FOr your first point I don't know what you want to mean? Why Samumed could not have a japan's partnered like replicel did? Why you tell that they legally can't do it?

For the last, yes I know they are aware of all world regulations, I didn't mean to contact them just to tell 'hey look there is japan's laws' lol
But maybe we could have informations on why they don't do that, or if they plan to do that, etc

sorry for my english

----------


## FearTheLoss

Only stem cell treatments can skip phase 3, not drugs.

----------


## nameless

> This couldn't be more false, first of all Replicel is a Canadian company, they partnered with Shiseido, which is a Japanese company. Second of all, the Japanese rules don't apply to drugs. Third of all, having the forum contact Samumed will do nothing, because they legally can't do it. Lastly, these guys know what they are doing and don't need any of us here to help, to think that they don't know regulations of different areas around he globe is misinformed.


 * I think his point may have "some" validity. Yes, I know the new law in Japan applies to cell-based therapies but sometimes there are ways to convince regulators that a drug is cell-based on the basis of the effects it has on the cell. I don't have the exact language of the new Japan law in front of me so I don't know the specifics. Still, it is possible that their drug could be included -it depends on the exact language of the new Japan law.

* Also, even if the new Japan law doesn't apply to SM it's still faster to get drugs through the regulatory process in Japan than USA.

* I contacted Histogen a few years ago to tell them that there are other countries in the globe that move things faster than the USA FDA, and that Histogen could move their product through quicker in those countries WHILE AT THE SAME TIME still moving forward in the USA under the FDA rules, and the folks at Histogen were like "duh". They hadn't even thought of it. They're addicted to FDA. Drug companies want to bring drugs to market in USA so they're all focused on FDA and they aren't thinking outside of the box. It is a good idea to send emails to tell drug companies that they can bring drugs to market sooner in Japan (and other countries) while also proceeding with FDA trials. The drug companies are so focused on FDA approval that they don't think about having milti-tracks - one for FDA and one for speedier countries.

----------


## JayM

I'm with FearTheLoss here. Although there might be a different process like the new bill being passed so that it is able to make it to market quicker? But I was fairly sure it was only Stem cell treatments that can skip phase 3

----------


## lacazette

Oh okay so they can't skip phase 3, damn so let's forget the "before 2016" sorry^^

But drugs seems to be approved sooner in japan. Maybe the process is easier than US and we could gain 1 or 2 years if Samumed do a phase3 clinical trial in japan.

well I hope hehe

----------


## JayM

yeh dude but have you read this new bill which is being passed? I think its American right guys? not sure as I am British so didn't really read it (my bad) but could make it way more of an efficient process and maybe drugs currently in trial could be the first to benefit.

----------


## lacazette

I just read a bit right now and you're right : some quotes:

"A bill drafted by the House Energy & Commerce Committee's health panel would eliminate the need for randomized, controlled clinical trials, the gold standard for assessing whether a product is safe and effective.
Instead companies could submit data from observational studies, in which researchers have no control over the experiment, ongoing surveillance studies and other clinical experience.

In addition, the FDA would be allowed to approve new indications based on a review of clinical data summaries, rather than full packages, potentially speeding up the approval time.

The bill would also require the agency to consider using real world experience as opposed to randomized trials to support or satisfy requirements for post-market studies.

But companies are required to conduct additional trials to confirm that the expected benefit actually materializes. The bill would reduce the need for such trials.

It would also make it easier for companies to provide economic analyses to insurance companies and others involved in reimbursement. 

"If included in the final version of the bill, known as 21st Century Cures",
So the question is when? Any american here who can give us more information?
Im french and not aware of all that, it's the senate who gonna vote for that bill or what?

It could really be a great news if it's happening

----------


## lacazette

"20 june - House Energy & Commerce Chair Fred Upton (R-MI) has signaled he won't bring his 21st Century Cures bill to the floor next week as he continues to negotiate offsets,...."

Well it's seems that it is not far away. But I'm afraid that the bill won't be accepted because of industry lobbyists or whatever  :Frown:

----------


## It's2014ComeOnAlready

> "20 june - House Energy & Commerce Chair Fred Upton (R-MI) has signaled he won't bring his 21st Century Cures bill to the floor next week as he continues to negotiate offsets,...."
> 
> Well it's seems that it is not far away. But I'm afraid that the bill won't be accepted because of industry lobbyists or whatever


 From what I understand, everything in the bill is set up to be more beneficial for patients, as well as companies. The whole point of the bill is to develop drugs more quickly, and cheaper. Industry wants this. Patients want this. 

There will of course be some hurdles because of negotiations. I wouldn't worry too much.

----------


## lacazette

So it sounds good for us  :Smile: 

What Im wondering is if the bill pass, will all the HL treatments that are currently in clinical trials would benefit of these news laws, or is it too late for them and the new approval system will only concern the futur ones?

And also if the bill pass, in how many months will it be effective? Does it gonna change FDA's things already this year, or will we have to wait mooore longer.

Well if anyone could mail the authors/collaborators of the bill with simply clearly questions it could be cool.
I want to do it but i have a strange English writting, and I don't know how to formulate clearly the questions

----------


## It's2014ComeOnAlready

> So it sounds good for us 
> 
> What Im wondering is if the bill pass, will all the HL treatments that are currently in clinical trials would benefit of these news laws, or is it too late for them and the new approval system will only concern the futur ones?
> 
> And also if the bill pass, in how many months will it be effective? Does it gonna change FDA's things already this year, or will we have to wait mooore longer.
> 
> Well if anyone could mail the authors/collaborators of the bill with simply clearly questions it could be cool.
> I want to do it but i have a strange English writting, and I don't know how to formulate clearly the questions


 How it works is: once it goes through congress, it goes to the senate, once it goes through the senate, it goes to the President's desk. Once it's signed, it becomes law within 10 days, (or a very short time) I believe. The best part about all of this is that it has a lot of support by both democrats and republicans. It's very likely it will get to the President's desk, and he will probably be likely to sign it because for once in a long time, a bi-partisan bill has been presented by congress. Also, it improves upon changes he helped made through Obamacare. 

The FDA also gets $550 million to make the necessary changes. But once it's signed into law, it's the law. It should benefit drugs going into trials after it is signed. From everything I've read, it seems that this bill should get to the President's desk before the end of the year.

----------


## burtandernie

Lets hope it doesnt jeopardize safety though by trying to speed the whole thing up. Your always trading safety for money/time because those big double blind studies arent cheap and fast to do.

----------


## It's2014ComeOnAlready

> Lets hope it doesnt jeopardize safety though by trying to speed the whole thing up. Your always trading safety for money/time because those big double blind studies arent cheap and fast to do.


 I agree, but when it comes to a drug like Seti, which has been proven safe through thousands of participants, I do not care. Release it tomorrow.

----------


## lacazette

> How it works is: once it goes through congress, it goes to the senate, once it goes through the senate, it goes to the President's desk. Once it's signed, it becomes law within 10 days, (or a very short time) I believe. The best part about all of this is that it has a lot of support by both democrats and republicans. It's very likely it will get to the President's desk, and he will probably be likely to sign it because for once in a long time, a bi-partisan bill has been presented by congress. Also, it improves upon changes he helped made through Obamacare. 
> 
> The FDA also gets $550 million to make the necessary changes. But once it's signed into law, it's the law. It should benefit drugs going into trials after it is signed. From everything I've read, it seems that this bill should get to the President's desk before the end of the year.


 Thanks a lot dude for all these informations, it gives me hope and the smile  :Smile: 

This bill will help us to have new treaments sooner than expected.  And it's a Fu..... great new as I am nw4 at 27!

I also have hope on stem cell treatments and regenerative medecine in japan in 3-4 years. I want to believe it, I need to believe it ^^  I don't want the "in 5 years'' thing come back again and again, please God! lol

----------


## nameless

Does anyone else agree with my point that *if* anti-androgens regrow hair upstream from Wnt stimulation then that means that SM05445 would have to be applied permanently the same as anti-androgens have to be applied (or swallowed) permanently. 

I mean, if anti-androgen efficacy is on the same stream as Wnt efficacy then that means that if one has to be applied permanently then the other would have to be applied permanently also, right? 

And if anti-androgens work via the same pathway as Wnt simulation then that means that SM05445 might be an effective treatment if it's applied permanently but they might not figure that out if they cease treatment after a few months. It might take 4 - 6 months for improvement to be visible and if they only apply it 3 months then they wouldn't even see the improvement that would have happened if they kept applying it another month. Right?

----------


## TooMuchHairWontKillYou

> Does anyone else agree with my point that *if* anti-androgens regrow hair upstream from Wnt stimulation then that means that SM05445 would have to be applied permanently the same as anti-androgens have to be applied (or swallowed) permanently. 
> 
> I mean, if anti-androgen efficacy is on the same stream as Wnt efficacy then that means that if one has to be applied permanently then the other would have to be applied permanently also, right? 
> 
> And if anti-androgens work via the same pathway as Wnt simulation then that means that SM05445 might be an effective treatment if it's applied permanently but they might not figure that out if they cease treatment after a few months. It might take 4 - 6 months for improvement to be visible and if they only apply it 3 months then they wouldn't even see the improvement that would have happened if they kept applying it another month. Right?


 calm down  :Big Grin:  they know their job

----------


## burtandernie

All these questions will be answered as they develop it. Patience. I dont see anything new that is not a constant treatment like propecia that you have to use everyday.

----------


## It's2014ComeOnAlready

Proposed legislation from the 21st Century Cures Act:

"The initiative's proposals could help to revolutionize the current drug approval process. Today, pharmaceutical companies test thousands of compounds in the lab until they identify one that shows promising medical applications. Next, they conduct "phase I" trials on healthy adult males to ensure a drug is safe. Phase II trials provide an initial assessment of a drug's effectiveness in sick patients. Phase III, which involves thousands of volunteer patients, helps confirm the results of phase II trials. 

*The draft legislation will allow FDA regulators to approve a groundbreaking drug if it proves effective after a phase II trial. That will deliver treatments to patients much sooner and eliminate the need for some phase III trials, which take years and account for 90 percent of the total development costs for drugs that eventually gain FDA approval.* 

The 21st Century Cures Initiative will also spur new drug development by helping biotech companies "fail faster." Of all the potential medicines that enter phase I trials, only 8 percent ever receive FDA approval. The proposed legislation would expedite "adaptive clinical trials" which identify the failures -- the other 92 percent -- earlier. That prevents researchers from wasting time and money on drugs that ultimately don't pan out.

Identifying and scrapping those failures earlier in the research and development process will allow drug companies to redirect billions towards more promising treatments. If adaptive clinical trials can catch even 5 percent of eventual failures in phase I instead of phase III, pharmaceutical manufacturers will save at least $15 million per drug.

*The proposed changes mark the beginning of a transition towards a true 21st century innovation system that eliminates traditional phase II and III trials altogether. In such a system, doctors, insurers, and drug makers could use the power of big data to chart a drug's effectiveness and patient outcomes as soon as it proves safe in phase I trials. Using crowd-sourced, real world data will deliver lifesaving treatments to patients years quicker than the current clinical trial process."*

----------


## FearTheLoss

> Proposed legislation from the 21st Century Cures Act:
> 
> "The initiative's proposals could help to revolutionize the current drug approval process. Today, pharmaceutical companies test thousands of compounds in the lab until they identify one that shows promising medical applications. Next, they conduct "phase I" trials on healthy adult males to ensure a drug is safe. Phase II trials provide an initial assessment of a drug's effectiveness in sick patients. Phase III, which involves thousands of volunteer patients, helps confirm the results of phase II trials. 
> 
> *The draft legislation will allow FDA regulators to approve a groundbreaking drug if it proves effective after a phase II trial. That will deliver treatments to patients much sooner and eliminate the need for some phase III trials, which take years and account for 90 percent of the total development costs for drugs that eventually gain FDA approval.* 
> 
> The 21st Century Cures Initiative will also spur new drug development by helping biotech companies "fail faster." Of all the potential medicines that enter phase I trials, only 8 percent ever receive FDA approval. The proposed legislation would expedite "adaptive clinical trials" which identify the failures -- the other 92 percent -- earlier. That prevents researchers from wasting time and money on drugs that ultimately don't pan out.
> 
> Identifying and scrapping those failures earlier in the research and development process will allow drug companies to redirect billions towards more promising treatments. If adaptive clinical trials can catch even 5 percent of eventual failures in phase I instead of phase III, pharmaceutical manufacturers will save at least $15 million per drug.
> ...


 
WOW....this is huge. This means CB could be out by 2018, and seti could be out within a year and a half and bim could be out right away if it applies.

----------


## It's2014ComeOnAlready

> WOW....this is huge. This means CB could be out by 2018, and seti could be out within a year and a half and bim could be out right away if it applies.


 SM, too, if it succeeds in phase 2.

----------


## FearTheLoss

I wonder if this would apply to histogen hsc too?

----------


## FearTheLoss

If this gets passed into law and sm is successful it could be out this time next year

----------


## FearTheLoss

Actually, unfortunately, it seems this would only apply to life threatening illness, or more serious matters than hair loss. It doesn't eliminate a phase 3 for most

----------


## It's2014ComeOnAlready

> If this gets passed into law and sm is successful it could be out this time next year


 I really, really, really think this bill will pass. It has a lot of bi-partisan support AND is expected to get over 350 votes in congress (80%). Once it gets to the senate (which is also mostly republican), it should get the votes as well to get to Obama's desk. He spoke in his last State of the Union about "precision medicine." This bill tackles that to a degree, and helps build upon improvements made in healthcare by Obamacare. Also, it's bi-partisan, and started in congress. Barely anything has come out of congress in a really, long time. 

Also, the bill is expected to be signed into law before the year is out.

----------


## It's2014ComeOnAlready

> Actually, unfortunately, it seems this would only apply to life threatening illness, or more serious matters than hair loss. It doesn't eliminate a phase 3 for most


 Where does it say that? Everything I've read has this law applying to clinical trials in general, not especially for life-threatening illnesses only.

----------


## FearTheLoss

http://www.nejm.org/doi/full/10.1056/NEJMp1506964

----------


## It's2014ComeOnAlready

> http://www.nejm.org/doi/full/10.1056/NEJMp1506964


 Yes, of course serious illnesses are put at the forefront, but the bill talks about clinical trial design in general. Doesn't say, "only in the case of life-threatening illnesses."

----------


## TooMuchHairWontKillYou

Got this from Samumed web page 
http://www.samumed.com/platform/#pipeline

SM will be daily solution and have to be applied permanently (i guess)

 Alopecia:
A daily topical solution for male-pattern baldness or androgenic alopecia. Click here for more information on our Phase 2 study in the US.

----------


## lacazette

I hope the phase 3 will be shorter with that 21st century cure bill!!
But well, let's see before if they have good results to show in october
fingers cross

----------


## TooMuchHairWontKillYou

Hope they will show us the results from phase 2

----------


## nameless

> Got this from Samumed web page 
> http://www.samumed.com/platform/#pipeline
> 
> SM will be daily solution and have to be applied permanently (i guess)
> 
>  Alopecia:
> A daily topical solution for male-pattern baldness or androgenic alopecia. Click here for more information on our Phase 2 study in the US.


 Well then why are they only applying it to the heads of the subjects for 90 days? It seems to me that if the company's intention is for people to use it daily *permanently* then the FDA would demand studies that involve more than just 90 days of actual use.

----------


## It's2014ComeOnAlready

Samumed has a fancy new website, they're also one of the main sponsors for the WCHR 2015. Cool

----------


## macbeth81

Applying a topical solution for 90 days, is a daily topical solution. It is daily for 90 days.

Histogen saw continued improvement over a one year period using Wnt proteins and other growth factors after a single injection. If this treatment behaves similar, it won't need to be used continuously. Assuming hairs re-miniaturize, usage would be cycled otherwise finasteride would be required.

Otherwise these researchers are naively, optimistic and their trial will fail...

----------


## It's2014ComeOnAlready

> Applying a topical solution for 90 days, is a daily topical solution. It is daily for 90 days.
> 
> Histogen saw continued improvement over a one year period using Wnt proteins and other growth factors after a single injection. If this treatment behaves similar, it won't need to be used continuously. Assuming hairs re-miniaturize, usage would be cycled otherwise finasteride would be required.
> 
> Otherwise these researchers are naively, optimistic and their trial will fail...


 These treatments aren't the same. One is topical and activates the WNT pathway, the other is an injection of WNT proteins. Anagen entry takes 7-9 days, so using it continually for 90 days to see if there is an effect with continued use. 

I'm confused by the comparison, or the presumption that the researchers are naively optimistic.

----------


## It's2014ComeOnAlready

> Applying a topical solution for 90 days, is a daily topical solution. It is daily for 90 days.
> 
> Histogen saw continued improvement over a one year period using Wnt proteins and other growth factors after a single injection. If this treatment behaves similar, it won't need to be used continuously. Assuming hairs re-miniaturize, usage would be cycled otherwise finasteride would be required.
> 
> Otherwise these researchers are naively, optimistic and their trial will fail...


 lol wow I'm lazy and didn't fully read your comment. I see what you're saying. Nevermind

----------


## rdawg

Glad to see there are things happening behind the scenes with stuff like this and Bim/Kythera, CB etc.

at least we have news to look forward too, unlike years past where we had to dream of a random announcement. 

this and CB phase II should be finishing up in the next few months, it's fair to assume with the decent science behind these projects that an actual product may be coming to us in the next 2-3 years(give or take).

----------


## It's2014ComeOnAlready

> Glad to see there are things happening behind the scenes with stuff like this and Bim/Kythera, CB etc.
> 
> at least we have news to look forward too, unlike years past where we had to dream of a random announcement. 
> 
> this and CB phase II should be finishing up in the next few months, it's fair to assume with the decent science behind these projects that an actual product may be coming to us in the next 2-3 years(give or take).


 Great thing about it is, if that 21st century cures bill passes, we could see it sooner. Just read the bill has support of the majority of congress.

----------


## nameless

> Samumed has a fancy new website, they're also one of the main sponsors for the WCHR 2015. Cool


 Please provide a link showing that they're one of the main sponsors of the 2015 WCHR.

----------


## It's2014ComeOnAlready

> Please provide a link showing that they're one of the main sponsors of the 2015 WCHR.


 http://www.hair2015.org/

for some reason it won't allow the actual link from the page where it's listed, but you can find it towards the right top of the page if you click "sponsors and exhibits"

By clicking on "Samumed" is how I discovered their new website, and they seem to have a new logo or font for their branding.

----------


## TooMuchHairWontKillYou

is samumed awaking existing follicles? or it creates the new ones?

----------


## nameless

> Samumed has a fancy new website, they're also one of the main sponsors for the WCHR 2015. Cool


 Viviscal is one of the donors and Viviscal is a big joke.

----------


## lacazette

Nameless, there's also shampoo sponsors, etc everything that goes with hair.
You say viviscal it's a joke cause you have mpb and severe hair loss, but it's just another supplement to have more healthy hair in a normal person, with 'normal processus' of hair loss per day. So you're wrong to do conclusion like that.

And if you think samumed is joke, go tell this to the persons who are in cancer final phase, and who are testing their other molecule SM04755 in clinical trial...they have just few months letft to live, and stop other medication/chemotherapy, to try that samused pill twice a day. They will be happy that 'nameless' tell them is a joke company

they work on powerful drugs ( to modulate Wnt pathway ), we will have some results this year of their 0.15% and 0.25% topical phase 2 trial. 
So YES this is a good thing that they're in sponsoring of this congress, no matter what you say Mr.Pessimist ;p

----------


## nameless

> Nameless, there's also shampoo sponsors, etc everything that goes with hair.
> You say viviscal it's a joke cause you have mpb and severe hair loss, but it's just another supplement to have more healthy hair in a normal person, with 'normal processus' of hair loss per day. So you're wrong to do conclusion like that.
> 
> And if you think samumed is joke, go tell this to the persons who are in cancer final phase, and who are testing their other molecule SM04755 in clinical trial...they have just few months letft to live, and stop other medication/chemotherapy, to try that samused pill twice a day. They will be happy that 'nameless' tell them is a joke company
> 
> they work on powerful drugs ( to modulate Wnt pathway ), we will have some results this year of their 0.15% and 0.25% topical phase 2 trial. 
> So YES this is a good thing that they're in sponsoring of this congress, no matter what you say Mr.Pessimist ;p


 Calm down tiger. We're on the same team. I did not say SM04554 is a joke. I said Viviscal is a joke. I want SM05445 to be a big success just as much as you do.  I just think that there's reason for doubts.

----------


## It's2014ComeOnAlready

> Calm down tiger. We're on the same team. I did not say SM04554 is a joke. I said Viviscal is a joke. I want SM05445 to be a big success just as much as you do.  I just think that there's reason for doubts.


 Viviscal's hair fibers actually work quite well, and suit a purpose. Guaranteed their product is used a lot in TV and movies. People's confidence is greatly boosted if they can hide thinning spots.

Also, I think that Samumed's presence at the WCHR is a good sign, because the congress takes place one month after their phase 2 trial is complete. I think it's doubtful they would choose to participate unless their drug had shown promise of moving forward. Otherwise, what are they doing there? If their product is a dud, they end up looking incompetent by having a presence. Bad PR for their company.

----------


## nameless

> Viviscal's hair fibers actually work quite well, and suit a purpose. Guaranteed their product is used a lot in TV and movies. People's confidence is greatly boosted if they can hide thinning spots.
> 
> Also, I think that Samumed's presence at the WCHR is a good sign, because the congress takes place one month after their phase 2 trial is complete. I think it's doubtful they would choose to participate unless their drug had shown promise of moving forward. Otherwise, what are they doing there? If their product is a dud, they end up looking incompetent by having a presence. Bad PR for their company.


 I want to let you know that you're one of the best posters here. You have good answers. Your logic is good and you're intelligent. I express my doubts and you have excellent responses. For example, your point about them anticipating good results because they're participating at the WCHR 1 month after they learn their SM05445 results is a very good point. 

I disagree with your point that they would worry about bad pr if they don't have good news, but I do agree that if they don't have good news it's unlikely that they would be heavily involved in the WCHR. You see, they don't have any other hair loss drugs in their pipeline and they're not a major hair loss research company. So if their product is a dud they wouldn't have much reason to be heavily involved in the WCHR and they would probably just shut down their one drug hair loss program and disappear from hair research radar. But they're not. As a matter of fact, like you said, they are a major sponsor of the coming hair loss congress and I think you're right that this is a good sign. Why would they be getting so heavily involved if their one drug hair loss program is a dud?

----------


## Tomtom21

I really think of all treatments for near term release that SM has the most and best potential in terms of regrowth. So many studies linked to Wnt pathway in terms of hairloss as well as general regenerative medicine. I think they have something that will regenerate follicles, but I wont count my chickens before my eggs hatch. We will know soon enough. However, if you peep their other pipeline diseases for treatment they include liver disease, degenerative disc disease and alzheimers. I would think they have to really be on to something or know a great deal about the whole Wnt pathway to even begin to think that they will be able to effectively treat such degenerative diseases. Those diseases make AGA look like a paper cut, so hopefully they cracked it and we will be seeing hallelujah come the end of the year.

----------


## BDDFreak

So ima little confused guys, is sm04554 in phase 2b right now or phase 2a? I also would like to know if im understanding the 21st centuries cure act right. Am i wrong in assuming it will make certain drugs possible to be released on conditional approval as long as it is deemed safe (possibly during phase 2b) like the new japan laws regarding stem cell treatments?

----------


## nameless

> So ima little confused guys, is sm04554 in phase 2b right now or phase 2a? I also would like to know if im understanding the 21st centuries cure act right. Am i wrong in assuming it will make certain drugs possible to be released on conditional approval as long as it is deemed safe (possibly during phase 2b) like the new japan laws regarding stem cell treatments?


 Why are we even talking about phase 2a or phase 2b? Isn't the ongoing study just phase 2 and isn't the next study phase 3?

----------


## It's2014ComeOnAlready

> Why are we even talking about phase 2a or phase 2b? Isn't the ongoing study just phase 2 and isn't the next study phase 3?


 This is phase 2 dose ranging. Next is phase 3.

----------


## BottleCap

If we find out it works, if they tell us it works after trials  Do you think this will become available on the black market like  RU AND CB?

----------


## lacazette

> If we find out it works, if they tell us it works after trials  Do you think this will become available on the black market like  RU AND CB?


 I don't think so, as they protect their molecule details

But even if it would be possible, it will be like playing with death!  the molecule manipulate the Wnt/β-catenin Signaling Pathway . And this Wnt pathway is directly responsible of cancer when is activity is too high ( that's why their other molecule in trial is a one that inhibit this  Wnt/β-catenin Signaling Pathway)

It is saying in different studies, that researchers have the tools for a safely delivery for skin regeneration, without cancer risks, but I wouldn't play with that kind of stuff on black market (if it becomes possible), really risky

----------


## nameless

> I don't think so, as they protect their molecule details
> 
> But even if it would be possible, it will be like playing with death!  the molecule manipulate the Wnt/β-catenin Signaling Pathway . And this Wnt pathway is directly responsible of cancer when is activity is too high ( that's why their other molecule in trial is a one that inhibit this  Wnt/β-catenin Signaling Pathway)
> 
> It is saying in different studies, that researchers have the tools for a safely delivery for skin regeneration, without cancer risks, but I wouldn't play with that kind of stuff on black market (if it becomes possible), really risky


 
It seems to me that the patent would include the details of the delivery system. Has anyone found the patent?

Also, is there any chance that this could become available sooner somewhere in Asia or anywhere?

----------


## burtandernie

Yeah its silly to play with the WNT pathway. You have to wait for them figure it all out so a few years wait.

----------


## nameless

> If we find out it works, if they tell us it works after trials  Do you think this will become available on the black market like  RU AND CB?


 
I'm with you. I think we should try to figure out a way to make that happen. I think we need to find the patent. I think the patent would include the delivery vehicle.

----------


## nameless

> Yeah its silly to play with the WNT pathway. You have to wait for them figure it all out so a few years wait.


 No it's not insane to play with the Wnt pathway. In fact, they are doing so right now and the USA Federal Government (FDA) is allowing them to do so. We should get the patent and figure out exactly how they are doing this and follow their instructions.

----------


## BDDFreak

So this article is clearly speaking on the negatives of the 21st century cures act, but the only real thing i got from it was the bill removes phase 3 as a requirement from the approval process! If it passes and sm04554 is successful we very well may see it on shelves by late 2016.

https://www.collective-evolution.com...eard-about-it/

----------


## lacazette

Modulating hair follicle size with Wnt10b-DKK1 pair during hair regeneration
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4383245/

"Here, we show that in response to prolonged ectopic Wnt10b-mediated β-catenin activation, regenerating anagen hair follicles grow larger in size. In particular, the hair bulb, dermal papilla and hair shaft become enlarged"

"these data suggest that WNT10b may have a proliferative effect on hair matrix and DP cells and that interactive signaling between extra epithelial and mesenchymal cells may later lead to the enlarged hair follicle phenotype. Furthermore, since the hair fiber and IRS are derived from hair keratinocyte precursors (34), differentiation of the increased matrix cell progenitor pool or their progeny may lead to a thickened hair shaft."

 "In the present study, we found aberrant localization of hyperproliferative hair stem cells during WNT10b induction. Therefore, WNT10b might stimulate hair stem cells to proliferate and migrate from the bulge region to replenish hair matrix cells."

"Notably, in our study, DP size correlated with hair follicle size. It was reported that epidermal activation of β-catenin results in ectopic hair formation associated with increased fibroblast proliferation"

"Therefore, it is possible that the WNT10b-induced canonical Wnt/β-catenin pathway could also directly promote proliferation and enlargement of the DP"


This is how SM04554 should work for us. Damn , that would mean even our  miniaturized hair could grow better and come back to normal terminal hair (like we saw in few cases of minox/fin, but with that modulation of Wnt pathway, they directly doing what follicles don't do well for hair formation because of the DHT and other factors. 
Instead of androgen drug that just reduce a factor that lead to this affected formation process.

The more I read on wnt/b catenin, the more im convince it is the more promising thing. Even big Norwood could have an ht, cause SM will work on all follicles, so then ameliore the ones of us with poor donor area zone, and we know how it is the most important aspect for a good HT

----------


## JayM

Lacazette you find some really good stuff. Quick question as I'm not so pro with all this, where are you finding all these articles? Is it the same people doing the research?

----------


## lacazette

> Lacazette you find some really good stuff. Quick question as I'm not so pro with all this, where are you finding all these articles? Is it the same people doing the research?


 Hey jay no no it is published studies from researchers all other the world
To find them I type key words in Google, like for an exemple "Wnt/β-catenin Signaling Pathway, hair follicle", and you choose "results from the last year". Like that, when you write 'scientific' key words, the majority of the links will lead to published studies from researchers

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## JayM

Aha must just be my inability to do things efficiently then. It sounds like a lot of different researchers are all going down this route. I guess it's because manipulating the wnt pathway has been proven to work on humans in other areas so it's a link from bloody rats to humans haha.

----------


## nameless

We need to get this SM stuff.

I think it's pretty odd that the guy who said the nurse told him it doesn't work hasn't come back. I think that, that is a sign that SM is working and he's falling into line with the company's nondisclosure rules because he does not want to risk being cut off.

----------


## hellouser

> We need to get this SM stuff.
> 
> I think it's pretty odd that the guy who said the nurse told him it doesn't work hasn't come back. I think that, that is a sign that SM is working and he's falling into line with the company's nondisclosure rules because he does not want to risk being cut off.


 That's one hell of an assumption.

----------


## nameless

> That's one hell of an assumption.


 LOL! You're right. 

I meant to say that it *"could be" a sign that SM is working and he's falling into line with the company's nondisclosure rules because he does not want to risk being cut off."*

I don't know why I typed it IS a sign of that when I meant to say it MIGHT BE a sign of that. 

But I do have a point that it MIGHT BE a sign of what I indicated. The poster was obvious willing to blast out info for awhile and then all of a sudden he clammed up. I do think that, that is most likely a good sign. If SM didn't work he most likely would be willing to keep violating the nondisclosure agreement because he wouldn't care much if they dumped him.

----------


## Hemo

> We need to get this SM stuff.
> 
> I think it's pretty odd that the guy who said the nurse told him it doesn't work hasn't come back. I think that, that is a sign that SM is working and he's falling into line with the company's nondisclosure rules because he does not want to risk being cut off.


 LOL or he was full of shit?

----------


## nameless

> LOL or he was full of shit?


 
If he was just some full-of-sh!t troll then he would still be doing it. I reject the possibility that he was just some full-of-shit troll.

----------


## Kiwi

> That's one hell of an assumption.


 lol that's what I thought :P

----------


## nameless

> lol that's what I thought :P


 Like I later said, I meant to say that he MAY HAVE gone quiet because the treatment is working and he doesn't want to risk being dumped. I know I said that it IS a sign that the treatment is working and he doesn't want to be dumped, but that is not what I meant to say. Still, I do believe that the fact that he has clammed up is a good sign. I think it means that he doesn't want to be cut loose.

----------


## lacazette

> If he was just some full-of-sh!t troll then he would still be doing it. I reject the possibility that he was just some full-of-shit troll.


 "he would still be doing it", you don't take in consideration that he could be died, in psychatric hospital, founded a woman, founded an active life, being in prison, etc,etc.. haha x)

Do you know how many months he was on the trial when he claimed those things?

----------


## nameless

> "he would still be doing it", you don't take in consideration that he could be died, in psychatric hospital, founded a woman, founded an active life, being in prison, etc,etc.. haha x)
> 
> Do you know how many months he was on the trial when he claimed those things?


 
None of the things you stated would prevent him from continuing to post and none of them are likely to have happened in such a short period of time. Also, it doesn't matter how long he was on the trial because he could have learnt that the drug was working from other ways besides the drug actually working on him. For example, the same nurse who told him that she didn't see any improvement on any patients may have started seeing some improvement on patients and she may have told him or he may have talked to test-patients who were having success with the drug. 

The point is that he's stopped sharing info for some reason and in my view that seems like it's probably a good sign. I'm not saying that I'm sure it's a good sign; I'm just saying that it seems like it's PROBABLY a good sign. It shows that for some reason he's decided to become compliant.

----------


## lacazette

Yes I agree, it could be a good sign more than a bad. fingers crossed! I really believe in this all Wnt pathway world, we will know more at the hair congress

----------


## BottleCap

What are some good estimates of the release of this treatment?

also when do people think CB, Pilofocus, Sepi, replicel and others are likely to be available. Really getting anxious were going to miss out, and be the last generation to be bald ugly bastards.

----------


## nameless

I want this patent.

----------


## BottleCap

> I want this patent.


 I do too.

Does anyone know if the molecular structure details of this chemical will be released after these trials finish?
Is it really that dangerous manipulating WMT pathways if the drug is sound?
I really neeeed this topical!

----------


## It's2014ComeOnAlready

> I want this patent.


 http://www.google.com/patents/US20140080902

----------


## deuce

IDK about the other but I heard CB will be out in 2021.  Ouch that sucks.  I was hoping 2017-2018.




> What are some good estimates of the release of this treatment?
> 
> also when do people think CB, Pilofocus, Sepi, replicel and others are likely to be available. Really getting anxious were going to miss out, and be the last generation to be bald ugly bastards.

----------


## JayM

> I do too.
> 
> Does anyone know if the molecular structure details of this chemical will be released after these trials finish?
> Is it really that dangerous manipulating WMT pathways if the drug is sound?
> I really neeeed this topical!


 I think by just misspelling the pathway just kinda proves it. Yes. Yes it is that dangerous. I wouldn't mess around with this.

----------


## nameless

> I think by just misspelling the pathway just kinda proves it. Yes. Yes it is that dangerous. I wouldn't mess around with this.


 
Listen, if you make black-market RU58841 incorrectly it's bad for you but if you make it right it's not bad for you. Lots of people have been using black-market RU58841 that is made correctly for years and nobody is getting hurt. It all depends on getting it made correctly. I would be very comfortable using black-market SM if its made correctly.

----------


## hellouser

> Listen, if you make black-market RU58841 incorrectly it's bad for you but if you make it right it's not bad for you. Lots of people have been using black-market RU58841 that is made correctly for years and nobody is getting hurt. It all depends on getting it made correctly. I would be very comfortable using black-market SM if its made correctly.


 I agree.

But we need to know the makeup of SM first.

----------


## nameless

If SM05445 works it's probably 3 years away. After completion of phase 2 it will probably take 6 - 8 months before phase 3 even starts and then phase 3 will be a year and then after phase 3 completes it will take 6 - 8 months for the company to assess the data and turn it over to the FDA and then it will take a year for the FDA to give approval. We are looking at 3 years easy.

----------


## JayM

What I mean is you would be an idiot to use it before you know the safety profile, the amount used and importantly how often it is applied. 

I think we must be on the same page there as no one would be stupid enough otherwise.

----------


## Hemo

> Listen, if you make black-market RU58841 incorrectly it's bad for you but if you make it right it's not bad for you. Lots of people have been using black-market RU58841 that is made correctly for years and nobody is getting hurt. It all depends on getting it made correctly. I would be very comfortable using black-market SM if its made correctly.


 Yeah?  How are you going to determine if it's made correctly?

----------


## nameless

> Yeah?  How are you going to determine if it's made correctly?


 
By giving a good company the patent/recipe. 


There are companies out there making good RU and other drugs. These companies have chemists are the payroll who can follow the instructions to the letter if we get them the instructions. The problem isn't how to get it made correctly; the problem is to get the patent/recipe.

----------


## nameless

> What I mean is you would be an idiot to use it before you know the safety profile, the amount used and importantly how often it is applied. 
> 
> I think we must be on the same page there as no one would be stupid enough otherwise.


 
Of course I would wait until after phase 2 results are in before using it but those results are just a few months away. Now is the time when we need to be finding the patent/recipe so we can be ready to act if the results are safe and effective.

----------


## nameless

> http://www.google.com/patents/US20140080902


 Are you saying that this is the patent to SM04554? Does this link tell us exactly how to make it? Is it a 100% certainty that this is the correct patent? 

As soon as we get the patent we need to start going through it but people keep posting links to multiple patents and it's not clear to me if these are the actual patents to the exact drug SM04554.

----------


## SolarPowered Man

I've skimped through it and it seem to be the recipe for it. We just need someone from a microbiology background to confirm.

----------


## nameless

How can we get someone with an understanding of microbiology/chemistry to help us figure out if this is the correct patent or not? 

http://www.google.com/patents/US20140080902

----------


## It's2014ComeOnAlready

> How can we get someone with an understanding of microbiology/chemistry to help us figure out if this is the correct patent or not? 
> 
> http://www.google.com/patents/US20140080902


 Nameless, I'm certain this is the correct patent.

----------


## nameless

> Nameless, I'm certain this is the correct patent.


 How can you be sure? How come nobody else is sure but you are?

If this is really the patent then we need to get this information to the movers and shakers.

----------


## nameless

> Nameless, I'm certain this is the correct patent.


 I would like to talk with you.

----------


## It's2014ComeOnAlready

> Nameless, I'm certain this is the correct patent.


 In the patent: "Numerous approaches have been suggested for treating hair loss. Two of the most commonly used and accepted compounds for preventing hair loss are minoxidil, the active ingredient in Rogaine® and the 5α-reductase inhibitor, finasteride, the active ingredient in Propecia®. However, cosmetic treatment of age-related hair loss in patients with topical solution of minoxidil or finasteride has resulted in only moderate regrowth of hair in less than 40% of such patients. Indeed, less than ten percent of the men who use Rogaine® achieve satisfactory results. Thus, there is a need in the art for more effective methods of, and compositions for treating hair loss. Preferably, new methods and compositions will require fewer applications of active ingredients; provide hair regrowth sooner, in more abundance, and thicker, than presently observed with minoxidil or finasteride treatment.

It has been found that hair follicle development and regeneration are regulated by the canonical Wnt/β-catenin signaling pathway [Investigative Dermatology (2008), 128(5), 1081-1087]. In the epidermis, hair follicle development is initiated when mesenchymal cells populate the skin. During this process, signals emanating from the dermis induce epithelium thickening, elongation of the epithelial cells, and the formation of placodes containing Wnt-responsive cells. In response, placodes signal dermal cells to condense, thereby forming the dermal papilla component of the hair follicle, which is also responsive to Wnt signaling. Wnt3α is secreted from hair epithelium and acts in an autocrine and paracrine fashion, and it has been demonstrated that Wnt-3α maintains anagen gene expression in dermal papilla cells and mediates hair-inductive activity in an organ culture. This Wnt-3α-mediated hair growth might depend on the canonical Wnt/β-catenin signaling pathway because deletion of β-catenin or the Lef1 gene resulted in hair loss in mice. Therefore, activation of β-catenin by Wnt contributes to the inhibition of keratinocytes differentiation, induction of hair follicle formation, and maintenance of proliferation of neuronal progenitors."

BTW, there are A LOT of peer reviewed journals that show WNT-3a maintains anagen expression, activates b-catenin, thus maintaining hair inducing properties.

----------


## nameless

> In the patent: "Numerous approaches have been suggested for treating hair loss. Two of the most commonly used and accepted compounds for preventing hair loss are minoxidil, the active ingredient in Rogaine® and the 5α-reductase inhibitor, finasteride, the active ingredient in Propecia®. However, cosmetic treatment of age-related hair loss in patients with topical solution of minoxidil or finasteride has resulted in only moderate regrowth of hair in less than 40% of such patients. Indeed, less than ten percent of the men who use Rogaine® achieve satisfactory results. Thus, there is a need in the art for more effective methods of, and compositions for treating hair loss. Preferably, new methods and compositions will require fewer applications of active ingredients; provide hair regrowth sooner, in more abundance, and thicker, than presently observed with minoxidil or finasteride treatment.
> 
> It has been found that hair follicle development and regeneration are regulated by the canonical Wnt/β-catenin signaling pathway [Investigative Dermatology (2008), 128(5), 1081-1087]. In the epidermis, hair follicle development is initiated when mesenchymal cells populate the skin. During this process, signals emanating from the dermis induce epithelium thickening, elongation of the epithelial cells, and the formation of placodes containing Wnt-responsive cells. In response, placodes signal dermal cells to condense, thereby forming the dermal papilla component of the hair follicle, which is also responsive to Wnt signaling. Wnt3α is secreted from hair epithelium and acts in an autocrine and paracrine fashion, and it has been demonstrated that Wnt-3α maintains anagen gene expression in dermal papilla cells and mediates hair-inductive activity in an organ culture. This Wnt-3α-mediated hair growth might depend on the canonical Wnt/β-catenin signaling pathway because deletion of β-catenin or the Lef1 gene resulted in hair loss in mice. Therefore, activation of β-catenin by Wnt contributes to the inhibition of keratinocytes differentiation, induction of hair follicle formation, and maintenance of proliferation of neuronal progenitors."
> 
> BTW, there are A LOT of peer reviewed journals that show WNT-3a maintains anagen expression, activates b-catenin, thus maintaining hair inducing properties.


 
Does this only work on the Wnt - Wnt3? I hoped it worked on all Wnts. Everyone knows Wnt7 is instrumental to hair growth.

Also, I appreciate your excerpt and it was great reading but I did not see where it said that this patent is for SM04554. Can you please tell me how you know for sure that this patent is for SM04554?

----------


## It's2014ComeOnAlready

> Does this only work on the Wnt - Wnt3? I hoped it worked on all Wnts. Everyone knows Wnt7 is instrumental to hair growth.
> 
> Also, I appreciate your excerpt and it was great reading but I did not see where it said that this patent is for SM04554. Can you please tell me how you know for sure that this patent is for SM04554?


 I'm fairly certain this is the patent. It's the only Samumed patent that includes anything related to hair or WNT activation and hair. Also, it was filed a few months before their phase 1 trial. 

I sincerely hope you're not trying to get someone to make this stuff. If made improperly, this stuff could maybe cause cancer.

----------


## hellouser

> I'm fairly certain this is the patent. It's the only Samumed patent that includes anything related to hair or WNT activation and hair. Also, it was filed a few months before their phase 1 trial. 
> 
> I sincerely hope you're not trying to get someone to make this stuff. If made improperly, this stuff could maybe cause cancer.


 Get hair or die trying.

----------


## Dimoxynil

> Get hair or die trying.


 Idiot

----------


## nameless

> I'm fairly certain this is the patent. It's the only Samumed patent that includes anything related to hair or WNT activation and hair. Also, it was filed a few months before their phase 1 trial. 
> 
> I sincerely hope you're not trying to get someone to make this stuff. If made improperly, this stuff could maybe cause cancer.


 I'll say it again...every blackmarket drug we use could be dangerous if it isn't made correctly, but we use them anyway. As a matter of fact, some of the legal drugs that we use could be harmful even if we make them properly but we use them anyway. 

The blackmarket drug-makers, such as Kane, have chemists on board who go through patents with a fine tooth comb and fully understand these patents. They know what they're doing.

----------


## nameless

> Idiot


 
Relax dude.

----------


## BottleCap

> I'm fairly certain this is the patent. It's the only Samumed patent that includes anything related to hair or WNT activation and hair. Also, it was filed a few months before their phase 1 trial. 
> 
> I sincerely hope you're not trying to get someone to make this stuff. If made improperly, this stuff could maybe cause cancer.


 We'll get it made properly then. Is this really much more different than the likes of CB,RU,Seti,OC that people have made in labs?

----------


## hellouser

> Idiot


 Excuse me?

----------


## nameless

> We'll get it made properly then. Is this really much more different than the likes of CB,RU,Seti,OC that people have made in labs?


 + a HUGE 1.

----------


## nameless

> http://www.google.com/patents/US20140080902


 Someone at another site said this patent has more than one compound in it. So we have to figure out a way to determine which compound is SM04554. 


Some of us at the bald truth are talking about funding Hellouser's trip to the upcoming Hair Loss Congress the same way we funded Desmond's trip last year. Perhaps if we funded Hellouser's trip he could go in as a press-person the same as Desmond did last year, and if he went in as a press person he could maybe interview the staff involved with SM04554, and maybe during the interview he could find out from the company which of the 3 compounds is SM04554.

----------


## xyz123

It appears that Samumed has launched a second Phase 2 trial for SM04554 that includes scalp biopsies to try and clarify its mechanism of action.  The study size is smaller relative to the initial Phase 2 study (50 vs 300).  

https://clinicaltrials.gov/ct2/show/...sm04554&rank=1

Although purely speculative, this may be a good sign - if there was no signal of efficacy in the original study, then I think it's unlikely that they'd do a follow-up mechanistic study.  Hopefully it's an indication that that the results are promising (to note, the original study is still not finished - timeline set for October, 2015).  So who knows - maybe they are pleased with the results and want to try and clarify the mechanism of action before launching a Phase 3 study.

If the results are impressive - this could end up being a great topical.  The follow-up time in these studies is 90 days - so if it works, it works pretty quickly.  And the primary endpoint in the scalp biopsy study is a change in the number of hair bulbs - which may imply that the investigators are anticipating that the drug was successful at triggering follicular neogenesis.  The inclusion criteria for the study was NW 4-6, so they were clearly focused on regrowth.

Lastly - others had suggested that the US Army was running a hair loss trial using a topical out of Wake Forest in Winstom-Salem.  However, Winston-Salem is a site for the initial SM04554 Phase 2 study - so I suspect SM04554 is the topical being investigated - and not a US Army initiative.

----------


## xyz123

It appears that Samumed

----------


## JayM

I assume the biopsies will be 50 from the original 300? I'm intrigued a lot about this but they could have been going to do this anyway.

----------


## JayM

Oh I just realised they are actually recruiting. Does anyone live near them?! Man I wish I lives in America.

----------


## xyz123

Fair point.  The scalp biopsies have to be done before and after treatment.  There was no indication in the original study that they were doing scalp biopsies - and if they weren't done pre-treatment, then they can't use the same people.  The new study is listed as "currently recruiting participants" which implies that they are looking for new people.  Given that this is something that really needs to be done prospectively - I think it's a bona fide new trial - but of course, can't be certain.

----------


## JayM

I'm still on the fence though whether this is good news or bad. I guess they wouldn't bother doing this if they didn't see results. But then again maybe they didn't and want to see if anything did happen to the follicles? hmm but then I also assume they saw at least something in the phase 1 to carry onto phase 2? aha oh man anyone on here like an expert on trials and might know whats happening?

----------


## xyz123

I don't think it's possible to know for certain.  However if they saw no results, I really can't see them launching another study to try to explain negative results.  They're a relatively small biotech company - if the results were negative, I think they'd cut their losses and move on.  As someone else highlighted, it's interesting that they are a Silver sponsor of the WCH - that's a big investment for a relatively small biotech company.  Their initial Phase 2 trial is scheduled to finish in October - so the timing would be good for them to announce their (hopefully impressive) results at WCH in November.

Who knows - with the anticipated passing of the 21st century cures act, maybe this modified Phase 2 trial is being designed to provide additional surrogate outcome data to avoid having to complete a full Phase 3 trial before coming to market.  That said - although the 90 day primary outcome is impressive with regards to the potential quick impact of the treatment - it's odd that they don't have longer follow-up included as well - ? 1 year - for both efficacy and safety purposes.

----------


## nameless

> It appears that Samumed has launched a second Phase 2 trial for SM04554 that includes scalp biopsies to try and clarify its mechanism of action.  The study size is smaller relative to the initial Phase 2 study (50 vs 300).  
> 
> https://clinicaltrials.gov/ct2/show/...sm04554&rank=1
> 
> Although purely speculative, this may be a good sign - if there was no signal of efficacy in the original study, then I think it's unlikely that they'd do a follow-up mechanistic study.  Hopefully it's an indication that that the results are promising (to note, the original study is still not finished - timeline set for October, 2015).  So who knows - maybe they are pleased with the results and want to try and clarify the mechanism of action before launching a Phase 3 study.
> 
> If the results are impressive - this could end up being a great topical.  The follow-up time in these studies is 90 days - so if it works, it works pretty quickly.  And the primary endpoint in the scalp biopsy study is a change in the number of hair bulbs - which may imply that the investigators are anticipating that the drug was successful at triggering follicular neogenesis.  The inclusion criteria for the study was NW 4-6, so they were clearly focused on regrowth.
> 
> Lastly - others had suggested that the US Army was running a hair loss trial using a topical out of Wake Forest in Winstom-Salem.  However, Winston-Salem is a site for the initial SM04554 Phase 2 study - so I suspect SM04554 is the topical being investigated - and not a US Army initiative.


 
Man, this is good news and your analysis is spot on. I'm not 100% sure that the drug works yet but things are looking pretty positive. You are absolutely right that it's highly unlikely that they would even bother with this special phase 2 unless they were seeing good results and the fact that they are using only NW 4-6 also is highly indicative that they are seeing regrowth. It's not 100% certain but it's looking very VERY good. 

We need to send Hellouser to the 2015 hair loss congress and he needs to interview the lead temporary contract researcher (Wilma Bergfeld) AND whoever Samumed sends from it's permanent staff to act as their spokesman. If he goes in prepared he could probably get it from them which is the correct compound in the patent and then we could possibly get it made. Otherwise we wait 3 years.

----------


## breakbot

I'm a negative-non optimistic poster but i believe this drug is something huge.
It's obvious if they didn't see results that they wouldn't bother to add another trial, which means more money.
I think better days are coming....

----------


## JayM

Is there a specific time frame a phase 3 trial has to go through? I mean of they are going to do this after a 90 day period then that bodes well if there is no limit. 

Also would they do this if it wasn't for the 21st century cure act? Like that's a genuine question I'm no expert.

----------


## It's2014ComeOnAlready

> It appears that Samumed has launched a second Phase 2 trial for SM04554 that includes scalp biopsies to try and clarify its mechanism of action.  The study size is smaller relative to the initial Phase 2 study (50 vs 300).  
> 
> https://clinicaltrials.gov/ct2/show/...sm04554&rank=1
> 
> Although purely speculative, this may be a good sign - if there was no signal of efficacy in the original study, then I think it's unlikely that they'd do a follow-up mechanistic study.  Hopefully it's an indication that that the results are promising (to note, the original study is still not finished - timeline set for October, 2015).  So who knows - maybe they are pleased with the results and want to try and clarify the mechanism of action before launching a Phase 3 study.
> 
> If the results are impressive - this could end up being a great topical.  The follow-up time in these studies is 90 days - so if it works, it works pretty quickly.  And the primary endpoint in the scalp biopsy study is a change in the number of hair bulbs - which may imply that the investigators are anticipating that the drug was successful at triggering follicular neogenesis.  The inclusion criteria for the study was NW 4-6, so they were clearly focused on regrowth.
> 
> Lastly - others had suggested that the US Army was running a hair loss trial using a topical out of Wake Forest in Winstom-Salem.  However, Winston-Salem is a site for the initial SM04554 Phase 2 study - so I suspect SM04554 is the topical being investigated - and not a US Army initiative.


 Awesome find. Please post more.

----------


## xyz123

Yeah - I think the new Phase 2 trial is a good sign - but I guess we can't be totally certain.  Given the short 90 day follow-up period - to play devil's advocate - I guess it's conceivable that they saw minimal results - however before cashing out after years of work and millions of dollars of investment, they're doing scalp biopsies to see if there are any sub-clinical positive changes occurring - which would indicate that they should invest in a longer follow-up period to try and detect cosmetically meaningful regrowth.

But I think this scenario is less likely - the objective of the study is supposed to be to determine the mechanism of action of SM04554 - so if it was not producing meaningful results, there would be no point in elucidating a mechanism of action and wasting money that could be spent on other drugs in their pipeline.

In addition to getting a better sense of the efficacy of the drug, the scalp biopsies may also be important for establishing safety.  Given that the drug modulates the Wnt/beta-catenin pathway, it has the potential to be oncogenic (a history of skin cancer is an exclusion criterion for the study) - so the biopsy may also be looking for any potential signal of harm.

Lastly - although the drug is applied daily for the 3 month study period, I doubt that the vision is for the drug to be applied daily for an indefinite period given the concern that chronic upregulation of the Wnt/beta-catenin pathway could significantly increase your risk of cancer.  Although speculating again - I suspect the idea is that the drug stimulates stem cells to activate/restore dormant and miniaturized follicles.  Once you get adequate regrowth (and hence all of the necessary follicles working), you would stop the drug.  But of course, although the follicles may be working again - they are still vulnerable to DHT - so you'd have to be on maintenance therapy to preserve your results (and hopefully seti can serve that role instead of fin in a few years... ).  This concept is somewhat similar to the vision of the Follicept group - though I am much more optimistic about SM05445 than I am about IGF-1 alone (especially given that Histogen had relatively modest results with a product that included IGF-1, coupled with the relatively dismal results of Follicept thus far...).  Consistent with this line of thinking, in the Phase 1 trial for SM04554, they only applied the drug for 14 days, but monitored for hair growth out to 28 days.

Hopefully hellouser can shed light on all of these issues when he goes to Miami.  I'm really hoping Samumed reports their results at the congress - it would suck to have to wait, seemingly indefinitely, for the study results - which seems to be happening right now for bimatoprost.  Although who knows what the future holds - I think that the only two new drugs we have a chance of seeing in the next 2-3 years in North America are SM04554 and bimatoprost - hopefully they come sooner than later...

----------


## nameless

> I'm still on the fence though whether this is good news or bad. I guess they wouldn't bother doing this if they didn't see results. But then again maybe they didn't and want to see if anything did happen to the follicles? hmm but then I also assume they saw at least something in the phase 1 to carry onto phase 2? aha oh man anyone on here like an expert on trials and might know whats happening?


 The phase 1 didn't involve a great deal of medication. They didn't apply very much. I doubt if they learnt much about hair growth from the phase 1.  But I don't think they would be doing a special phase 2 to find out what is going on under the skin (biopsies) unless the FDA wanted to know exactly and specifically what effects the medicine is having under the skin so I think that the FDA probably demanded this special phase 2 study. And I don't think that Samumed would fund this extra study unless they saw something in the original phase 2 study that looked promising. I think that if the FDA ordered Samumed to do an additional phase 2, but the original phase 2 produced nothing positive, then Samumed would just kill the project. Why spend the money on the special phase 2 if the original phase 2 produced nothing positive?????


Then again, I think it's also possible that Samumed may have decided to do this study on their own (without the FDA mandating it) because Samumed saw no positive results above the skin so Samumed wants to find out if SM04554 is having any positive effects below the skin.

----------


## nameless

> It appears that Samumed has launched a second Phase 2 trial for SM04554 that includes scalp biopsies to try and clarify its mechanism of action.  The study size is smaller relative to the initial Phase 2 study (50 vs 300).  
> 
> https://clinicaltrials.gov/ct2/show/...sm04554&rank=1
> 
> Although purely speculative, this may be a good sign - if there was no signal of efficacy in the original study, then I think it's unlikely that they'd do a follow-up mechanistic study.  Hopefully it's an indication that that the results are promising (to note, the original study is still not finished - timeline set for October, 2015).  So who knows - maybe they are pleased with the results and want to try and clarify the mechanism of action before launching a Phase 3 study.
> 
> If the results are impressive - this could end up being a great topical.  The follow-up time in these studies is 90 days - so if it works, it works pretty quickly.  And the primary endpoint in the scalp biopsy study is a change in the number of hair bulbs - which may imply that the investigators are anticipating that the drug was successful at triggering follicular neogenesis.  The inclusion criteria for the study was NW 4-6, so they were clearly focused on regrowth.
> 
> Lastly - others had suggested that the US Army was running a hair loss trial using a topical out of Wake Forest in Winstom-Salem.  However, Winston-Salem is a site for the initial SM04554 Phase 2 study - so I suspect SM04554 is the topical being investigated - and not a US Army initiative.


 
One negative thing is that (if this drug works) this additional phase 2 will lengthen the timeline before it comes to market and so now if it works we will have to wait 4 years for it. All the more reason we should fund Hellouser's trip to the Congress under the condition that he will pursue interviews with the lead investigator (Wilma Bergfeld) and whatever Samumed staff-person that Samumed sends to the Congress so that he might secure information about which compound in the SM04554 is the correct drug.

----------


## It's2014ComeOnAlready

I'm honestly confused. I think it's positive, because they're spending more money to get more data. But, why weren't they measuring these things in the first place? Why the need for additional studies?

----------


## JayM

Wasn't there another company who have come back to do scalp biopsies during phase 2? This could just be the natural progression of what they normally do. I mean we have never really seen a new experimental drug reach phase 3 so who knows?

----------


## nameless

> I'm honestly confused. I think it's positive, because they're spending more money to get more data. But, why weren't they measuring these things in the first place? Why the need for additional studies?


 I'm confused too but for different reasons. One thing that confuses me is why they need to do a study to count hair BULBS? Either their phase 2 showed new hair growth or it didn't. And why would they spend money on a special phase 2 if they didn't see new hairs in phase 2? I do not get it. 

At any rate, the new study is 6 months long. I guess it will have to be completed before a phase 3 can be started. This special phase 2 completes in January 2016. Then the company and FDA will go through that information and this process could take 1 month or it could take numerous months. I figure that if it progresses to phase 3 the phase 3 will start somewhere between March 2016 and August 2016. It would complete in August 2017 and then it would take about 1 year (or longer) for FDA approval. It would hit the market about August 2018. If this stuff works were looking at a 3 year wait. Some people say we have located the patent while other people aren't as sure. Even the people who say we have isolated the patent say that there are 3 different compounds in the patent. If we can figure out for certain which drug it is then we could possibly get it made and avoid the 3 year wait.

----------


## lacazette

I hope it's a good sign  :Smile: 

When I read again things like this, I really think SM will help us, even for miniaturized follicles

http://www.ncbi.nlm.nih.gov/pubmed/24750467

Modulating hair follicle size with Wnt10b/DKK1 during hair regeneration

"Here, we showed that in response to prolonged ectopic Wnt10b-mediated β-catenin activation, regenerating anagen hair follicles grew larger in size. In particular, the hair bulb, dermal papilla and hair shaft became enlarged

We observed dramatically enhanced proliferation within the matrix, DP and hair shaft of the enlarged AdWnt10b-treated hair follicles compared with those of normal hair follicles at P98. Furthermore, expression of CD34, a specific hair stem cell marker, was increased in its number to the bulge region after AdWnt10b treatment. Many CD34-positive hair stem cells were actively proliferating in AdWnt10b-induced hair follicles

Together, these findings strongly suggest that Wnt10b/DKK1 can modulate hair follicle size during hair regeneration

----------


## It's2014ComeOnAlready

> *One negative thing is that (if this drug works) this additional phase 2 will lengthen the timeline before it comes to market and so now if it works we will have to wait 4 years for it*. All the more reason we should fund Hellouser's trip to the Congress under the condition that he will pursue interviews with the lead investigator (Wilma Bergfeld) and whatever Samumed staff-person that Samumed sends to the Congress so that he might secure information about which compound in the SM04554 is the correct drug.


 Please don't stamp your own timelines on things, no one knows how long it's gonna take. This trial is only from July to January. The original trial goes until October, so that's an additional two months. 

Also take into consideration the very likely passing of the 21st Century Cures Act, which has been planned to be passed before the year is out, and they haven't budged on that goal. If the law passes at the same time all the phase 2 trials are complete, with this additional data, it could speed things up.

----------


## nameless

> I hope it's a good sign 
> 
> When I read again things like this, I really think SM will help us, even for miniaturized follicles
> 
> http://www.ncbi.nlm.nih.gov/pubmed/24750467
> 
> Modulating hair follicle size with Wnt10b/DKK1 during hair regeneration
> 
> "Here, we showed that in response to prolonged ectopic Wnt10b-mediated β-catenin activation, regenerating anagen hair follicles grew larger in size. In particular, the hair bulb, dermal papilla and hair shaft became enlarged
> ...


 
Does SM04554 affect Wnt10b/DKK1?

I think someone posted that SM04554 affects Wnt3, but did not mention anything about Wnt10b/DKK1 or Wnt7a.

----------


## nameless

> Please don't stamp your own timelines on things, no one knows how long it's gonna take. This trial is only from July to January. The original trial goes until October, so that's an additional two months. 
> 
> Also take into consideration the very likely passing of the 21st Century Cures Act, which has been planned to be passed before the year is out, and they haven't budged on that goal. If the law passes at the same time all the phase 2 trials are complete, with this additional data, it could speed things up.


 
At the time I posted that it will take 4 years I did not know that the new phase 2 is only 6 months. Also, from October to end of January is about 3 - 4 months, not 2 months. Keep in mind that they will have to spend time assessing the data from the two phase 2 trials and then get the green light from the FDA to move to phase 3 before they can go to phase 3. When Samumed went from phase 1 to phase 2 there was an 8-month gap between the two studies. 

Also, I do not think that the 21st Century Cures Act will have much of an affect on SM04554 for a number of reasons. Firstly, after an act is passed it takes a little while before it becomes law. Andby the time it becomes law SM04554 will have already completed all phase 2 trials anyway. Secondly, the law may allow the FDA to continue conducting things as the FDA in the past to allow the FDA time to adjust to the new law. Lastly, I have not heard anywhere that the 21st Century Cures Act would eliminate a need for a phase 3 trial for topically applied drugs. Are you saying that the 21st Century Cures Act could eliminate the need for a phase 3 study before a topically applied drug is approved? Please enlighten me. 

I'm under the impression that the 21st Century Cures Act will have no effect on SM04554. If I'm wrong please enlighten me. I would love some good news.

----------


## lacazette

> Does SM04554 affect Wnt10b/DKK1?
> 
> I think someone posted that SM04554 affects Wnt3, but did not mention anything about Wnt10b/DKK1 or Wnt7a.


 I think it's linked as they are talking about modulating the Wnt pathway in general

in the study it's say "Therefore, it is possible that the WNT10b-induced canonical Wnt/β-catenin pathway could also directly promote proliferation and enlargement of the DP"

and in the SM patent they talk a lot about activation of Wnt/β-catenin pathway. Maybe the activation by Wnt3 or Wnt10b have nearly the same consequences when regarding the Wnt/β-catenin pathway
They also talk about DKK1 in the patent

----------


## lacazette

In the SM patent : 

"With respect to hair loss, the canonical Wnt/β-catenin signaling pathway is known to regulate hair follicle development and regeneration
Wnt3α is secreted from hair epithelium and acts in an autocrine and paracrine fashion, and it has been demonstrated that Wnt-3α maintains anagen gene expression in dermal papilla cells and mediates hair-inductive activity in an organ culture. This Wnt-3α-mediated hair growth might depend on the canonical Wnt/β-catenin signaling pathway "

So it sounds like Wnt3a help to maintain anagen phase, and Wnt10 help to enlarge the hair follicle.

----------


## nameless

> In the SM patent : 
> 
> "With respect to hair loss, the canonical Wnt/β-catenin signaling pathway is known to regulate hair follicle development and regeneration
> Wnt3α is secreted from hair epithelium and acts in an autocrine and paracrine fashion, and it has been demonstrated that Wnt-3α maintains anagen gene expression in dermal papilla cells and mediates hair-inductive activity in an organ culture. This Wnt-3α-mediated hair growth might depend on the canonical Wnt/β-catenin signaling pathway "
> 
> So it sounds like Wnt3a help to maintain anagen phase, and Wnt10 help to enlarge the hair follicle.


 
So then you might need both. 

I do recall reading about a product that purportedly put Wnt10 into the scalp and the product is available.

----------


## nameless

> Please don't stamp your own timelines on things, no one knows how long it's gonna take. This trial is only from July to January. The original trial goes until October, so that's an additional two months. 
> 
> Also take into consideration the very likely passing of the 21st Century Cures Act, which has been planned to be passed before the year is out, and they haven't budged on that goal. If the law passes at the same time all the phase 2 trials are complete, with this additional data, it could speed things up.


 I just read that the 21st century Cures Act would allow for drugs to come to market after a phase 2 study in cases of "groundbreaking" medicines. I wonder if this only applies to life-saving drugs??? I wonder if this could apply to a cosmetic drug????

----------


## hellouser

> In the SM patent : 
> 
> "With respect to hair loss, the canonical Wnt/β-catenin signaling pathway is known to regulate hair follicle development and regeneration
> Wnt3α is secreted from hair epithelium and acts in an autocrine and paracrine fashion, and it has been demonstrated that Wnt-3α maintains anagen gene expression in dermal papilla cells and mediates hair-inductive activity in an organ culture. This Wnt-3α-mediated hair growth might depend on the canonical Wnt/β-catenin signaling pathway "
> 
> So it sounds like Wnt3a help to maintain anagen phase, *and Wnt10 help to enlarge the hair follicle.*


 AFAIK, size of follicle is relative to thickness of hair. That's exactly what we need.

----------


## It's2014ComeOnAlready

> At the time I posted that it will take 4 years I did not know that the new phase 2 is only 6 months. Also, from October to end of January is about 3 - 4 months, not 2 months. Keep in mind that they will have to spend time assessing the data from the two phase 2 trials and then get the green light from the FDA to move to phase 3 before they can go to phase 3. When Samumed went from phase 1 to phase 2 there was an 8-month gap between the two studies. 
> 
> Also, I do not think that the 21st Century Cures Act will have much of an affect on SM04554 for a number of reasons. Firstly, after an act is passed it takes a little while before it becomes law. Andby the time it becomes law SM04554 will have already completed all phase 2 trials anyway. Secondly, the law may allow the FDA to continue conducting things as the FDA in the past to allow the FDA time to adjust to the new law. Lastly, I have not heard anywhere that the 21st Century Cures Act would eliminate a need for a phase 3 trial for topically applied drugs. Are you saying that the 21st Century Cures Act could eliminate the need for a phase 3 study before a topically applied drug is approved? Please enlighten me. 
> 
> I'm under the impression that the 21st Century Cures Act will have no effect on SM04554. If I'm wrong please enlighten me. I would love some good news.


 We're gonna have to get you a "jump to conclusions" mat.

Anyway, how many months are between October and January? Two. They are November and December. Also, it doesn't show anywhere that it's the "end of January." 

The 21st Century Cures Act speeds up the development process of drugs in many ways. Nobody can say for sure what effect it will have on any trials. But if by law, the drug process is streamlined, and they are allowed to use biomarkers and surrogate endpoints for primary outcome measures, then it is likely that it will help.

----------


## nameless

> We're gonna have to get you a "jump to conclusions" mat.
> 
> Anyway, how many months are between October and January? Two. They are November and December. Also, it doesn't show anywhere that it's the "end of January." 
> 
> The 21st Century Cures Act speeds up the development process of drugs in many ways. Nobody can say for sure what effect it will have on any trials. But if by law, the drug process is streamlined, and they are allowed to use biomarkers and surrogate endpoints for primary outcome measures, then it is likely that it will help.


 
LOL! For all you know the present phase 2 ends in early October and the special phase 2 ends in late January. You don't know. You're guessing. You're assuming the most favorable scenario because that's what you want to happen, but right now you don't know. And you should always plan for the worse. You should hope for the best but plan for the worse. The bottom line that the new study is somewhere between 2 and 4 months from the present study.

----------


## lacazette

Damn, I can't wait til november héhé I really want to know what kind of results this drug could give.
It's the first one who play with the wnt pathway modulating, and this way seems far more powerful in the studies than simply anti androgens shit,etc. 
So who knows, it could be quite a cure in combination with a big HT, even for big Norwoods

----------


## nameless

> I think it's linked as they are talking about modulating the Wnt pathway in general
> 
> in the study it's say "Therefore, it is possible that the WNT10b-induced canonical Wnt/β-catenin pathway could also directly promote proliferation and enlargement of the DP"
> 
> and in the SM patent they talk a lot about activation of Wnt/β-catenin pathway. Maybe the activation by Wnt3 or Wnt10b have nearly the same consequences when regarding the Wnt/β-catenin pathway
> They also talk about DKK1 in the patent


 
Why would they even mention the Wnt10 pathway if the drug (SM04554) has no effect on the Wnt10 pathway?

----------


## XoTiC

> Damn, I can't wait til november héhé I really want to know what kind of results this drug could give.
> It's the first one who play with the wnt pathway modulating, and this way seems far more powerful in the studies than simply anti androgens shit,etc. 
> So who knows, it could be quite a cure in combination with a big HT, even for big Norwoods


 May not even need a HT for that matter, probably being too hopeful but from what I've read on it the pathway is able to promote hair growth in dormant follicles therefore awakening them and thickening. We'll have to wait and see the results, but it does sound promising.

----------


## nameless

I think that the fact that the company is doing this 2nd study is a VERY positive development. 

a) The company likely knows by now whether or not the test subjects in the phase 2 study grow hair or not. 
b) The company likely would have done the biopsies in the original phase 2 study if they intended to do biopsies all along so it's likely that the idea of doing this biopsy study is something they only recently decided to do.
c) It's very doubtful that they would have decided to do this special phase 2 study if they did not see positive results from the original phase 2 study. 

So they likely know if their drug grows hair or not and they decided to invest more money into another trial

*ALSO*

d) I've been reading on the internet where experts are saying that the new FDA law will allow companies to move their treatments into the marketplace after phase 2 studies if the treatment is "groundbreaking" and the FDA is agreeable. 
e) By Samumed doing this additional study they are securing more information that they can turn over to the FDA. 
f) Samumed is surely aware of the new FDA law that might become law.


It looks to me like there is a possibility that Samumed may have decided that by doing the additional phase 2 study (involving biopsies) they could get more info to turn over to the FDA and then maybe the FDA would let their drug into the marketplace after phase 2. And the timing fits this scenario because the new phase 2 will be done by the end of January and of course the new FDA law will become law (or rejected) just about that same time. The timing makes it look to me like Samumed may have had the new law in mind when they decided to do this additional phase 2. 

Also, they may have figured out that if they instead set-up for a phase 3 study then that phase 3 study will cost them a lot more money and a phase 3 study will make it take longer to get their drug to market so they'll have to wait longer to start earning profits from the drug, and it's a bad thing to take longer to get to market because other breakthrough treatment(s), such as Shisheido's advertised iPS cells, will come to market soon and grab a big chunk of market-share.

----------


## lacazette

Prague Jan 2014

Signaling Involved in Hair Follicle Morphogenesis
and Development

https://www.mdpi.com/1422-0067/15/1/1647/pdf

HF morphogenesis starts at an early embryonic stage. Its proper development and
regular cycles involves a strong interplay between Wnt, Hedgehog, Notch and bone morphogenetic
protein (BMP) signaling pathways.

"The Wnt pathway is considered to be the master regulator during
hair follicle morphogenesis

Currently,
only a few attempts to modify these pathways have been performed in the treatment of abnormalities
such as alopecia. Although some promising drugs have emerged with the ability to target pathway
effectors, providing some success in the treatment of hair follicle abnormalities"

----------


## TooMuchHairWontKillYou

They should try to make wnt inhibitor for hair removal :d

But of course first hair regrowth !!!  :Roll Eyes (Sarcastic):

----------


## lacazette

So any one in US is interested to participate SM phase 2 complement? still 90 days of topical application 

There's still 3 locations that recruiting

Research Site Recruiting 
College Station, Texas, United States  
Contact: Jeremy Scott       jscott@js-studies.com 
Principal Investigator: Terry Jones, M.D.           

Research Site Recruiting 
Houston, Texas, United States  
Contact: Amanda Herod       aherod@sba-skincare.com 
Principal Investigator: Suzanne Bruce, M.D.           
United States, Virginia 

Research Site Recruiting 
Lynchburg, Virginia, United States  
Contact: Sue Foster       sfoster@educationandresearch.com 
Principal Investigator: Janet Hickman, M.D.           


The new outcome measures are really interesting, with the scalp biopsy analyze
https://clinicaltrials.gov/ct2/show/...atenin&rank=19

----------


## Parsia

> So any one in US is interested to participate SM phase 2 complement? still 90 days of topical application 
> 
> There's still 3 locations that recruiting
> 
> Research Site Recruiting 
> College Station, Texas, United States  
> Contact: Jeremy Scott       jscott@js-studies.com 
> Principal Investigator: Terry Jones, M.D.           
> 
> ...


 I live in dallas so its near to college station , I like to attend that, thanks for your info. my only concern is I have some regrowth with my current treatment , how about if it doesn't work for me? lol

----------


## lacazette

> I live in dallas so its near to college station , I like to attend that, thanks for your info. my only concern is I have some regrowth with my current treatment , how about if it doesn't work for me? lol


 Hey dude I read more the exclusion criterias and sorry but :
Use of any products or devices clinically proven to promote scalp hair growth (e.g., finasteride or minoxidil) within 24 weeks prior to study start

So 24 weeks it's when they will finish this little trial

But you are Lucky if you have some regrowth ^^ what is your regimen?

----------


## inbrugge

I would actually be interested as I'm also in Dallas and I frequently visit College Station. I'm not on Fin, Min, etc, so I'm good on that aspect.

However, I don't think I meet Norwood criteria. Also, I'm not sure if I feel experimenting with possible cancer-causing pathways. 

Although, after reading this thread, I am quite interested in this product and will be anxiously waiting for the results.

A quick question:

Are we aware of any connection between the Wnt pathways and COX/PGD/PGE pathways, which also seems to be a strong theory based on a lot of scientific research?

----------


## champpy

So how do they know if anyone is actually on fin, minox or any other hair product. Do they test for traces of these drugs in your system?
Basically im asking, if we lie and say we are not using other treatments how do they know if thats true or not?

----------


## It's2014ComeOnAlready

> So how do they know if anyone is actually on fin, minox or any other hair product. Do they test for traces of these drugs in your system?
> Basically im asking, if we lie and say we are not using other treatments how do they know if thats true or not?


 lol you're not going to get it by them. They've spent millions on these trials, trust me, you won't be able to fool them.

It would be like trying to buy alcohol with a fake ID at a sports arena with a multi-million dollar liquor license.

----------


## Hemo

> So how do they know if anyone is actually on fin, minox or any other hair product. Do they test for traces of these drugs in your system?
> Basically im asking, if we lie and say we are not using other treatments how do they know if thats true or not?


 Well considering they're doing scalp biopsies during the expanded phase 2, I imagine your current treatments would show up in some sense, at least minox...but sure, go for it, you might get lucky.

----------


## lacazette

GUYS I really think this drug will be huge when I read this !! (this come from Fujiwara Lab, (lab from RIKEN center where there is Tsuji lab aswell)

The Wnt/β-catenin signaling pathway has been found to play a crucial role for hair follicle development and regeneration, and stimulation of stem cell growth, maintenance and differentiation. 

Our another recent study has revealed that activation of canonical Wnt/beta-catenin signalling in the epidermal stem cell population, induces differentiation of dermal adipocyte progenitors 

We showed that periodical activation of epidermal Wnt/beta-catenin signalling during hair growth cycle induces morphogenesis and regeneration of the hypodermis by triggering the secretion of epidermal adipogenic factors, synchronizing the hair follicle growth with underlying dermal adipocyte differentiation. 

Thus, our recent findings indicate that hair follicle epidermal stem cells not only contribute to hair follicle maintenance and regeneration, but also provide niches for dermal cell populations"

Now when we look more precisely their study  :Smile:  : 

Wnt/β-catenin signaling in keratinocytes is activated by topical application of 4-hydroxytamoxifen (4OHT) to mouse dorsal skin. A single application to telogen skin is sufficient to stimulate anagen, whereas six treatments not only stimulate anagen of existing follicles but also induce ECTOPIC HF formation as a result of expansion of the epidermal stem cell compartment and reprogramming cells in the sebaceous gland and interfollicular epidermis to differentiate along the hair follicle lineages (9). 
http://www.pnas.org/content/111/15/E1501.long

When the Wnt pathway is activated at high levels in adult mouse epidermis, ectopic follicles form from existing follicles, interfollicular epidermis (IFE) and sebaceous glands, revealing a remarkable ability of the tissue to be reprogrammed
http://www.sciencedirect.com/science...12160610002356


So it seems like SM could , not only help existing and dormant follicles, but also create NEW FOLLICLES from existing ones!!!

----------


## xyz123

Agreed - getting proper modulation of the Wnt pathway could change everything.  As Cotsarelis has highlighted, the stem cells are still there - they just need to be turned back on.  Let's hope this drug can pull this off...

----------


## lacazette

Cotsarelis 2007

When a wound is formed on the skin, stem cells can decide to become skin cells or hair follicle cells.
In the majority of the cases, they become skin cells so as to quickly heal the wound. In mice, the team found that if Wnt is restricted, no hair follicles are formed, so the mice become bald; if more Wnt is present, hair growth is increased.

Cotsarelis, Millar 2013

 if delivered in a limited, safe and controlled way, agents that activate Wnt signaling might be used to promote hair growth in dormant hair follicles in conditions such as male pattern baldness,” said senior author Sarah Millar, PhD,

Researchers aim to better understand the key components and functions of the Wnt/β-catenin pathway. Important areas of focus for future work will include developing effective means of safely targeting therapeutics to the skin for clinical and cosmetic applications. 

safely targeting therapeutic is what SM is ( for the moment)

Now what's happen if you put SM on the scalp just after the cotsarelis wounding clinical procedure?? 

After a wound, SM could be the key to decide stem cells to become HF cells instead of skin cells.

Now that I now that activation of Wnt/B catenin pathway could create NEW follicles from existing ones, it really makes me want to believe that SM could be the 'safely targeting therapeutic for skin' that follica need to apply after wounding. I'm maybe too optimistic but that b-catenin pathway world looks so good  :Stick Out Tongue:

----------


## Renee

Any idea on what's going on with cotsraelis &  follicabio?

----------


## nameless

What are the possible reasons for why Samumed is doing the supplemental phase 2 for SM04554? 

I see 2 possibilities:

1. The drug did not grow hair in the original phase 2 so they want to dig into the skin with biopsies to find out why?


2. The drug did grow hair so Samumed wants to collect as much data as possible to give to the FDA to increase the likelihood of the drug being approved. And Samumed may even be hoping that the FDA will allow the drug to come to market after completing phase 2 if the new 20th Century Cures Act passes and if Samumed can give the FDA enough info to satisfy the FDA by doing a detailed supplemental phase 2 with biopsies.

----------


## lacazette

Any info , just a new website design in 2015. I think I see that he will be at the hair congress.

----------


## lacazette

Wnt/β-catenin signaling in dermal condensates is required for hair follicle formation.

http://www.ncbi.nlm.nih.gov/pubmed/24309208

"In summary, these data reveal a functional role of Wnt signaling in DP precursors for embryonic hair follicle formation"


@Nameless, I think one of these two is more designed to assess dosing, and the other one is more designed to determine efficacy (like other clinical trials "phase 2a, 2b")

----------


## nameless

> Wnt/β-catenin signaling in dermal condensates is required for hair follicle formation.
> 
> http://www.ncbi.nlm.nih.gov/pubmed/24309208
> 
> "In summary, these data reveal a functional role of Wnt signaling in DP precursors for embryonic hair follicle formation"
> 
> 
> @Nameless, I think one of these two is more designed to assess dosing, and the other one is more designed to determine efficacy (like other clinical trials "phase 2a, 2b")


 
The more I think about it the more it looks to me like Samumed believes that the 21st Century Cures Act will pass and they're planning to ask for FDA approval after phase 2.

One of the big changes in the act is that the FDA will be allowed to use
biomarkers in the decision-making process whether or not to approve a drug.
Biopsies produce biomarkers and Samumed is doing scalp biopsies. So this extra phase
2 study that Samumed is doing is the exact kind of study they would have to do in order to secure early approval after phase 2.

----------


## Parsia

Hello Bro , Thanks for your clarification .

I used lipogaine minoxidil and also lipogaine shampo , I can say I've got cover almost all my crown and on top of my head. in frontal I've got 

not that much regrowth but thickness for sure. 

My result and pics on hairloss talk forum but you need to have account there to see them , if you like I can post it to you. 

I'm adding few more options for get more regrowth recently

----------


## nameless

I think that Samumed is probably trying to eliminate the phase 3 trial and go straight from phase 2 to the market-place. 

One of the specifics of the 21st Century Cures Act is that the phase 3 study can be eliminated and replaced by doing biomarkers instead. Samumed initiated an extra phase 2 out of the clear blue and this extra phase 2 involves biopsies. I think 
that biopsies produce biomarkers. I think that they may intend to use the biomarkers from the extra phase 2 study as a replacement for a phase 3 trial. 

Here's an article that shows that biomarkers can replace the phase 3 study if the 
21st Century Cures Act becomes law:

http://moderndayms.com/2015/07/u-s-h...ury-cures-act/

----------


## dus

> The more I think about it the more it looks to me like Samumed believes that the 21st Century Cures Act will pass and they're planning to ask for FDA approval after phase 2.
> 
> One of the big changes in the act is that the FDA will be allowed to use
> biomarkers in the decision-making process whether or not to approve a drug.
> Biopsies produce biomarkers and Samumed is doing scalp biopsies. So this extra phase
> 2 study that Samumed is doing is the exact kind of study they would have to do in order to secure early approval after phase 2.


 Wow, this could be really good... must. not. get. my. hopes. up. Anyway we would need an airbridge to us European baldies if it becomes available in the US.

----------


## lacazette

2014 β-Catenin activation regulates tissue growth non-cell autonomously in the hair stem cell niche

http://www.ncbi.nlm.nih.gov/pubmed/24653033

"Wnt/β-catenin signaling is critical for tissue regeneration."

"β-Catenin activation is sufficient to induce hair growth independently of mesenchymal dermal papilla niche signals normally required for hair regeneration"

The more I search, the more I strongly believe in SM
I've seen almost 30 studies that explained in details and determined exactly how B catenin activation plays a major crucial role for hair, and 90% of these studies are from the period 2013-2015
SAMUMED are the pionner in this area and hopefully a winner

I repost this quote that makes me dream (comes from a 2014 study of a japanese lab that work on tissue regeneration (in the same center where there is the Tsuji lab)

"Wnt/β-catenin signaling in keratinocytes is activated by topical application of 4-hydroxytamoxifen (4OHT) to mouse dorsal skin. A single application to telogen skin is sufficient to stimulate anagen, whereas six treatments not only stimulate anagen of existing follicles but also induce ECTOPIC HF formation as a result of expansion of the epidermal stem cell compartment and reprogramming cells in the sebaceous gland and interfollicular epidermis to differentiate along the hair follicle lineages (9). "

If B catenin activation can (not only induce anagen phase, make the existing HFs stronger and bigger, wake up the dormant ones), but can also grow NEW HF from existing ones, then I think we are almost saved! (maybe in combination with an ht for Norwoods 5/7) (and still with an anti DHT treatment to help these new follicles to achieve full growth without something that try to kill them hehe)

Now my biggest fear is that someone in the trial develop cancer, it would mean many other years of trial or even cancellation . So let's pray everything goes well, cause this drug is damn promising

A last one "Wnt/β-catenin signaling controls multiple aspects of skin epithelial regeneration, with its excessive activity promoting the hyperactivation of hair follicle stem/progenitor cells

----------


## lacazette

Nov 2014

http://jcb.rupress.org/content/207/4/549.full

Here, we show that miR-214 regulates skin morphogenesis and hair follicle (HF) cycling by targeting β-catenin, a key component of the Wnt signaling pathway. miR-214 exhibits differential expression patterns in the skin epithelium, and its inducible overexpression in keratinocytes inhibited proliferation, which resulted in formation of fewer HFs with decreased hair bulb size and thinner hair production. The inhibitory effects of miR-214 on HF development and cycling were associated with altered activities of multiple signaling pathways, including decreased expression of key Wnt signaling mediators β-catenin and Lef-1, and were rescued by treatment with pharmacological Wnt activators."

----------


## nameless

lacazette, I think that biopsies produce bio-markers. Doesn't it seem striking that Samumed is doing a biopsy/bio-marker phase 2 study at a time when a legislative act, favored to become law, allows drug companies to use bio-markers in lieu of Phase 3 studies? Check out this link and scroll down to "part 2." 

http://moderndayms.com/2015/07/u-s-h...ury-cures-act/

----------


## lacazette

Damn! you are right my friend, it's a clear possibility 

I wasn't aware of that! I was believing that elimination of phase 3 would be ONLY for rare and serious diseases but I was wrong! thank you dude you made my day  :Smile: 

its also said here : 
http://www.collective-evolution.com/...eard-about-it/

"The 21st Century Cures Act allows drugs to be rushed to the market, removes phase 3 testing as a requirement for drug approval, bases drug approval on biomarkers rather than actual health outcomes"

And here:
http://www.raps.org/Regulatory-Focus...ury-Cures-Act/

Subtitle B of Title II is slightly modified from the original draft of the legislation. It remains focused on the "qualification and use of drug development Tools
"The development of biomarkers and other drug development tools can benefit the availability of new medical therapies by helping translate scientific discoveries into clinical applications," the bill explains

Section 2022 of the draft legislation would amend federal law to facilitate accelerated approvals—approvals based on surrogate (e.g. intermediate) endpoints intended to serve as evidence that a drug would be effective in a population. FDA has long relied on surrogate endpoints to support accelerated approvals, but only for drugs intended to treat patients with life-threatening illnesses and unmet needs.The legislation would require FDA and a sponsor to enter into an "accelerated approval development plan" (AADP) similar in concept to a special protocol assessment (SPA). The AADP would establish the minimum data parameters which, if met, would support the approval of a drug using surrogate endpoints.


And from your link:

"This part of the bill allows drugs to get to the consumer quicker. This is because Phase 3 testing has been eliminated 
The new method replacing Phase 3 testing bases drug approvals on biomarkers, the way living cells react to specific things introduced to those cells


The real world effects of this Act are still unknown but the central point of contention is singularly rooted in the increased freedom and lack of oversight of pharmaceutical companies."


Sounds too good to be true x) 
Im not aware of us, when do this bill will defenitly be adopted? Is there obstacles to come or can we say that it's just a matter of time?

----------


## It's2014ComeOnAlready

It definitely seems like it's only a matter of time. There is too much support, politically, from the majority of health organizations, universities etc. 

beta-catenin expression is a biomarker, KI-67 expression is a biomarker, also having data on how those correlate to the outcomes of increased hair growth will be important. 

There is a lot to be positive about here. Hopefully the 21st Century Cures Act makes a difference in the speed of future trials.

Each of these drugs - SM, Seti, Bim (if it's not launched soon) are primed to be approved much sooner than later under these new laws.

----------


## Illusion

SM really is the only thing I'm looking forward to, the science behind it is just so solid... Dus makes a fair point though, would that 21st century  law mean that it could only be approved much earlier in the USA? Or would it be approved at the same time in Europe as well? Forgive my ignorance but I have no idea how all this regulation stuff works.

----------


## nameless

The 21st Century Cures Act has passed the house and now it's in the US Senate. I just sent messages to both of my US Senators asking them to support the 21st Century Cures Act - especially the part that allows the use of bio-markers instead of the phase 3 trial.

----------


## champpy

I haven't actually gone over any of the studies so forgive my ignorance...While a lot of these quotes from the studies sound great, please tell me that this has been tested on more than mice and rats?

----------


## champpy

and is it likely that when their phase 2 is actually over, we're going to have another eight+ month waiting period like we are currently having with Bim before we find out any results

----------


## xyz123

> I haven't actually gone over any of the studies so forgive my ignorance...While a lot of these quotes from the studies sound great, please tell me that this has been tested on more than mice and rats?


 Actually - I'm not even aware of any animal data for this drug (the animal work was with other Wnt modulators)...

And rumor has it that the Phase 1 results were negative: "Samumed’s Phase 1 trial in Australia was completed and failed to show any hair growth, according to sources at the company. Subjects felt better, but hair counts were no different in the treated vs. placebo groups. To be fair, the study was only one month in duration, so quite short for a hair growth/re-growth trial. This trial will tell if activation of Wnt signaling in the scalp is a potential treatment for baldness." (http://www.hairlosscure2020.com/samu...4554/#comments).  Though like Replicel, Phase 1 was for safety and involved just 2 weeks of applying the topical.

Hopefully they deliver on Phase 2 - but we really have no idea - it's all just hype for now.  If the results are good, you've got to believe they'll present them at WCH in Miami in November...

----------


## It's2014ComeOnAlready

> Actually - I'm not even aware of any animal data for this drug (the animal work was with other Wnt modulators)...
> 
> And rumor has it that the Phase 1 results were negative: "Samumed’s Phase 1 trial in Australia was completed and failed to show any hair growth, according to sources at the company. Subjects felt better, but hair counts were no different in the treated vs. placebo groups. To be fair, the study was only one month in duration, so quite short for a hair growth/re-growth trial. This trial will tell if activation of Wnt signaling in the scalp is a potential treatment for baldness." (http://www.hairlosscure2020.com/samu...4554/#comments).  Though like Replicel, Phase 1 was for safety and involved just 2 weeks of applying the topical.
> 
> Hopefully they deliver on Phase 2 - but we really have no idea - it's all just hype for now.  If the results are good, you've got to believe they'll present them at WCH in Miami in November...


 what's the source for that phase 1 rumor?

----------


## xyz123

> what's the source for that phase 1 rumor?


 It's in the comments section following a post on sm04554 on the hairlosscure2020 website (link above) - the comment is written by someone named John H. - whatever that's worth...

But I've seen similar comments around the web - i.e. on Paul Knoepfler's website following an entry regarding stem cells for hair loss: 

"Paul Frohna, MD, PhD on October 9, 2014 at 11:18 pm said:

The topical drug by Samumed of San Diego, a wnt pathway activator designed to activate the stem cells within the hair folicule, has been tested in a Phase 1 dose ranging study in men with male pattern baldness in Australia. https://www.anzctr.org.au/Trial/Regi...aspx?id=364645 The trial has been completed but no results have been announced, although I heard that the trial didn’t meet its objective efficacy endpt of hair regrowth, but that pts reported a subjective improvement that the company was touting. So, although a small molecule modulator of endogenous stem cells in the hair follicle seems like a great and safe Idea, but it hasn’t worked yet and may never since the biology is very complex." 

Paul Frohna seems like a legit guy: https://www.linkedin.com/in/paulfrohna

Anyway - the bottom line is we have no idea if sm04554 is going to work.  Even if Phase 1 was completely negative for hair growth - the company must have had some compelling evidence to move forward with two Phase 2 trials.  And lacazette highlighted that longer duration of therapy with a Wnt activator can improve results: "_A single application to telogen skin is sufficient to stimulate anagen, whereas six treatments not only stimulate anagen of existing follicles but also induce ECTOPIC HF formation_".  

I'm still really optimistic and believe it could be amazing for regrowth - but it could still be a total bust...  We can review the literature regarding Wnts and hair growth as much as we'd like - it's not gonna change anything - we just have to wait...

----------


## lacazette

In this 2014 human clinical trial they used topical valproic acid  (activate B catenin pathway through gs3kb inhibition)

http://www.ncbi.nlm.nih.gov/pubmed/24533507

"Topical VPA increased the total hair counts of our patients; therefore, it is a potential treatment option for AGA."

So b catenin activation seems to work aswell in humans. It makes those recent mouse studies claims more interesting

In HLh forum, a guy who read the entire study, says that the VP acid have just little effect on B catenin activation. 

The major  question is does the Samumed targeting drug upregulated the wnt activation sufficiently to make the same stunning effects than in those mouse studies?

It's clear that wnt activation will give results on hair, but how stronger they can activate it without taking cancer risks that's the problem?

----------


## Sogeking

> Actually - I'm not even aware of any animal data for this drug (the animal work was with other Wnt modulators)...
> 
> And rumor has it that the Phase 1 results were negative: "Samumeds Phase 1 trial in Australia was completed and failed to show any hair growth, according to sources at the company. Subjects felt better, but hair counts were no different in the treated vs. placebo groups. To be fair, the study was only one month in duration, so quite short for a hair growth/re-growth trial. This trial will tell if activation of Wnt signaling in the scalp is a potential treatment for baldness." (http://www.hairlosscure2020.com/samu...4554/#comments).  Though like Replicel, Phase 1 was for safety and involved just 2 weeks of applying the topical.
> 
> Hopefully they deliver on Phase 2 - but we really have no idea - it's all just hype for now.  If the results are good, you've got to believe they'll present them at WCH in Miami in November...


 Sm sounds good in theory however there are too much conflicting information and people jumping to conclusions with wishful thinking.
I'm not sure if they are gonna show us anything in hair loss congress. I guess we'll have to wait and see.
That said I hope Sm is the real deal. I really do.

----------


## nameless

> Sm sounds good in theory however there are too much conflicting information and people jumping to conclusions with wishful thinking.
> I'm not sure if they are gonna show us anything in hair loss congress. I guess we'll have to wait and see.
> That said I hope Sm is the real deal. I really do.


 
What exactly do you think we are here at this website for? Do you think that we are here to cure hair loss? Do you think that we are here to cry about hair loss to each other? What do you think the point is to having this website?

I think it's here so we can discuss things related to hair loss, including to share our perspective on what drugs are coming and when. Doing this involves some speculation and I'm sure you would call that "wishful thinking." 

To hear you tell it people shouldn't post at all, including yourself. Nobody should even come here. People should just wait quietly until a cure comes to market and have no discussion in the meanwhile. But then why do you come here? Why do you come here when you know that people will be discussing their views about hair loss, cures for hair loss, and timelines for when those cures might come to market? 

There is no point for you to come here unless of course you're a phony complaining about other people speculating things about hair loss even as you're doing the exact same thing.

Go away!

----------


## lacazette

Androgenetic alopecia (AGA), is the most common type of alopecia in men, which is an androgen mediated event. Circulating androgens, including, dihydrotestosterone (DHT), enter the follicle via the DP's capillaries, bind to the androgen receptor within the DP cells and then activate or repress molecular signaling pathways responsible for premature transition from anagen to catagen and follicular miniaturization. This include suppression of stimulatory pathways of Wnt, Stat 3 and Shh and up-regulation of suppressive pathways (e.g., Dickkopf-related protein 1 and BMP 4). Dkk-1, which is secreted from DP cells in response to DHT pathway, is a potent inhibitor of Wnt pathway.[1] BMP 4 protein also acts through the activation of DKK pathway, thereby inhibiting hair follicular growth"

As they explained in the other studies, Wnt pathway activation act like a major signaling cascade regarding the other pathways. And so activate the good ones for hair, and repress the bad ones
Let's just hope that the Wnt upregulation lead by SM04554 will be safely high enough to correct the DHT consequences on these pathways

----------


## xyz123

> Androgenetic alopecia (AGA), is the most common type of alopecia in men, which is an androgen mediated event. Circulating androgens, including, dihydrotestosterone (DHT), enter the follicle via the DP's capillaries, bind to the androgen receptor within the DP cells and then activate or repress molecular signaling pathways responsible for premature transition from anagen to catagen and follicular miniaturization. This include suppression of stimulatory pathways of Wnt, Stat 3 and Shh and up-regulation of suppressive pathways (e.g., Dickkopf-related protein 1 and BMP 4). Dkk-1, which is secreted from DP cells in response to DHT pathway, is a potent inhibitor of Wnt pathway.[1] BMP 4 protein also acts through the activation of DKK pathway, thereby inhibiting hair follicular growth"
> 
> As they explained in the other studies, Wnt pathway activation act like a major signaling cascade regarding the other pathways. And so activate the good ones for hair, and repress the bad ones
> Let's just hope that the Wnt upregulation lead by SM04554 will be safely high enough to correct the DHT consequences on these pathways


 It's amazing how complex hair loss is - so many different biological pathways.  It's almost as if someone wanted to make it excessively complicated so that it would be near impossible to treat...

And it's also humbling - despite all of the potential new therapies coming along - how little we definitively know about AGA pathophysiology.

In Cotsarelis' 2011 JCI paper, the introduction stated:

"In AGA, the new lower hair follicle that forms at anagen onset is smaller than its predecessor. Testosterone is necessary for miniaturization, and 5-α-reductase type II inhibitors, which block conversion of testosterone to its more active form, dihydrotestosterone, delay progression of AGA (6). Little else is understood about the cause of AGA"

Now we know that PGD2 is also important.  But beyond that, AGA is still largely a black box.  Although I'm optimistic, we're really going to have to get lucky for one of these new treatments to have great efficacy.  It will happen at some point, but when...

----------


## Sogeking

> It's amazing how complex hair loss is - so many different biological pathways.  It's almost as if someone wanted to make it excessively complicated so that it would be near impossible to treat...
> 
> And it's also humbling - despite all of the potential new therapies coming along - how little we definitively know about AGA pathophysiology.
> 
> In Cotsarelis' 2011 JCI paper, the introduction stated:
> 
> "In AGA, the new lower hair follicle that forms at anagen onset is smaller than its predecessor. Testosterone is necessary for miniaturization, and 5-α-reductase type II inhibitors, which block conversion of testosterone to its more active form, dihydrotestosterone, delay progression of AGA (6). Little else is understood about the cause of AGA"
> 
> Now we know that PGD2 is also important.  But beyond that, AGA is still largely a black box.  Although I'm optimistic, we're really going to have to get lucky for one of these new treatments to have great efficacy.  It will happen at some point, but when...


  I'm telling you that we will create new hair follicles sooner than finding out the root cause of AGA, its mechanism and stopping it.

----------


## nameless

> It's amazing how complex hair loss is - so many different biological pathways.  It's almost as if someone wanted to make it excessively complicated so that it would be near impossible to treat...
> 
> And it's also humbling - despite all of the potential new therapies coming along - how little we definitively know about AGA pathophysiology.
> 
> In Cotsarelis' 2011 JCI paper, the introduction stated:
> 
> "In AGA, the new lower hair follicle that forms at anagen onset is smaller than its predecessor. Testosterone is necessary for miniaturization, and 5-α-reductase type II inhibitors, which block conversion of testosterone to its more active form, dihydrotestosterone, delay progression of AGA (6). Little else is understood about the cause of AGA"
> 
> Now we know that PGD2 is also important.  But beyond that, AGA is still largely a black box.  Although I'm optimistic, we're really going to have to get lucky for one of these new treatments to have great efficacy.  It will happen at some point, but when...


 We do not need to know all of the detals involved in aga in order to cure aga. I think that we already know enough of the details involved to cure it or we soon will.

----------


## xyz123

> I'm telling you that we will create new hair follicles sooner than finding out the root cause of AGA, its mechanism and stopping it.


 Agreed - though I don't think the battle is over after new hair follicles are created - the new follicles are unlikely to be 100% consistent with regular follicles - and there will be years of working on making them cosmetically acceptable, ensuring they regenerate after they fall out, and then there's the issue that they might be androgen sensitive and maintenance drugs will still be required...

That said - and to keep this thread on topic - after some more thought, I am 99% positive that the SM trial was positive - and believe it or not, this isn't just mental mast.rbation  :Smile: 

I'm involved in clinical trials in another area of medicine (that actually gets NIH funding...) and just realized - you canNOT conduct a clinical trial in humans when you know that the result is going to be negative - i.e. the notion of FUTILITY.

When you do a study in humans with an experimental drug and the result is negative - you can't go back to the FDA and say - "yeah, the drug doesn't work - but we'd like to gather some more information to find out why.  So would you mind if we ran another trial - it will just be another 50 people and this time we'll take scalp biopsies".  

It doesn't work like that - with animals, there's no problem with giving an ineffective drug to another 50 mice to gather more data to try and understand why.  But you can't do that with humans - to conduct another trial, you would have to change something about the protocol and provide justification why you think it will work this time (which usually means going back to the lab and generating additional data).  And that's not the case here - the protocol for both of the SM Phase 2 trials are COMPLETELY IDENTICAL.

And from a common sense perspective - this also makes sense.  Can you imagine getting informed consent for a patient when you know the drug doesn't work?  "Yeah - we're running a study for hair loss.  We just ran the same study and we know that the drug doesn't work.  But we want to try and understand why, so this time we're going to take a piece of your scalp at the start and end of the study - that will hurt, but not that much.  Oh - and by the way, although we know that the drug doesn't work, there's a small chance it could cause cancer.  So... wanna sign up?".  No way this happens.

The fact that they got permission from the FDA to run a second study means that the Data Safety Monitoring Board (DSMB) did an interim analysis of the study and found that the results were positive.  They communicated this to the FDA (they're required to) and based on these results - either the FDA or the company or both - decided that they wanted to better understand the mechanism through which this drug worked, which triggered the second study.

The first trial has to be positive.  SM works - believe it.  The question now is to what extent...

----------


## It's2014ComeOnAlready

Excellent post xyz123, you are an asset to this board. 

Hopefully they'll let us know how good the drug is at the hair congress.

----------


## Illusion

> Agreed - though I don't think the battle is over after new hair follicles are created - the new follicles are unlikely to be 100% consistent with regular follicles - and there will be years of working on making them cosmetically acceptable, ensuring they regenerate after they fall out, and then there's the issue that they might be androgen sensitive and maintenance drugs will still be required...
> 
> That said - and to keep this thread on topic - after some more thought, I am 99% positive that the SM trial was positive - and believe it or not, this isn't just mental mast.rbation 
> 
> I'm involved in clinical trials in another area of medicine (that actually gets NIH funding...) and just realized - you canNOT conduct a clinical trial in humans when you know that the result is going to be negative - i.e. the notion of FUTILITY.
> 
> When you do a study in humans with an experimental drug and the result is negative - you can't go back to the FDA and say - "yeah, the drug doesn't work - but we'd like to gather some more information to find out why.  So would you mind if we ran another trial - it will just be another 50 people and this time we'll take scalp biopsies".  
> 
> It doesn't work like that - with animals, there's no problem with giving an ineffective drug to another 50 mice to gather more data to try and understand why.  But you can't do that with humans - to conduct another trial, you would have to change something about the protocol and provide justification why you think it will work this time (which usually means going back to the lab and generating additional data).  And that's not the case here - the protocol for both of the SM Phase 2 trials are COMPLETELY IDENTICAL.
> ...


 Don't ever stop posting here please

----------


## Seuxin

Hello guys,

And do you except a real trial resul when ?

In two month ? More ?

----------


## lacazette

Agreed Xyz, it makes sense.

And the fact that Samumed is a small company, nor a hair company, but still is the third biggest sponsor of the hair congress makes me optimistic.

the VPA human trial confirmed that Bcatenin pathway activation give results

the question is how far they can go with that bcatenin pathway upregulation without playing with cancer risks

little activation will help to slow the AGA processus
medium activation could rstrongly slow the process for years, (or even stop further hairloss) and rescued the follicles that are in the beginning process of miniaturization
high activation lead to ectopic HF formation from existing ones (and then even a nw7 could come back on the Norwood scale after years of application ^^)

fingers crossed

----------


## xyz123

> the question is how far they can go with that bcatenin pathway upregulation without playing with cancer risks
> 
> little activation will help to slow the AGA processus
> medium activation could rstrongly slow the process for years, (or even stop further hairloss) and rescued the follicles that are in the beginning process of miniaturization
> high activation lead to ectopic HF formation from existing ones (and then even a nw7 could come back on the Norwood scale after years of application ^^)
> 
> fingers crossed


 Lacazette - I think it's got to be the last one.  Their inclusion criteria were NW 4-6 - so maintenance is not a reasonable goal (no one is going to pay for and apply a topical cream daily to remain a NW6).  And the endpoints in their trials (particularly the new one) is change in hair counts - this is not geared towards maintenance - especially with a 3 month follow-up - you wouldn't see anything.  And I really think the scalp biopsies are being done to look for follicular neogenesis - you can't prove that with visual inspection, but you can with pre-/post-scalp biopsies.

And their new trial only has a target enrollment of 50 people.  When you have a weak treatment for regrowth, you need to enroll a large number in order to show statistical significance (i.e. 1000 patients for the Propecia trials) - and for maintenance, you need to follow for years.  When you have a dramatic treatment that works quickly (i.e. lots of regrowth), you only need a handful of people for a short period of time to show benefit.

This second phase 2 trial - driven by the results of the first Phase 2 trial - is definitely going to be positive (they know exactly what's going to happen based on the identical protocol that they ran in the first trial).  So with 50 people split into 3 treatment arms, they are going to show an increase in terminal hairs in just 3 months.

This really may be the answer for many of us.  If the results are great, I have to believe they'll be presented in Miami.  And if they are, Samumed deserves to turn into a multi-billion dollar company.  Here's to California Biotech - you stay classy San Diego  :Smile:

----------


## maver1ck

Hey all. First time caller long time listener. Been following this thread very closely and I appreciate all the insight being given here. I also have high hopes for SM04554 but what I really want to know is how quickly this would be taken to market given the supposed efficacy and the emergence of the 21st century cares act. Are we looking at 1-2 years max? Or something more along the lines of 4-5?

----------


## xyz123

> Hey all. First time caller long time listener. Been following this thread very closely and I appreciate all the insight being given here. I also have high hopes for SM04554 but what I really want to know is how quickly this would be taken to market given the supposed efficacy and the emergence of the 21st century cares act. Are we looking at 1-2 years max? Or something more along the lines of 4-5?


 Pure speculation - but I would guess 1-3 year range.

If the 21st century cures act passes and applies to this drug, I think it could come to market in late 2016.

If the FDA still requires a Phase 3 trial, I think it will be 2018.  The Phase 3 trial will start in mid to late 2016 (there won't be delays - assuming the drug works, everyone and their grandmother will want to invest in this company), will last ~ 1 year, and then the FDA review will take 3-9 months.

That's my guess.  No way it takes 5 years if the drug truly works like we hope/think it will.

----------


## Dimoxynil

> Pure speculation - but I would guess 1-3 year range.
> 
> If the 21st century cures act passes and applies to this drug, I think it could come to market in late 2016.
> 
> If the FDA still requires a Phase 3 trial, I think it will be 2018.  The Phase 3 trial will start in mid to late 2016 (there won't be delays - assuming the drug works, everyone and their grandmother will want to invest in this company), will last ~ 1 year, and then the FDA review will take 3-9 months.
> 
> That's my guess.  No way it takes 5 years if the drug truly works like we hope/think it will.


 Just one question , 

Is the only reason were getting excited because they're testing on higher end NW scale men? 

If I was a cynic I would suspect that they would use higher NWs as false proof of maintainance. For example, most people loose hair more rapidly between NW 2-3 than say between 4-5. So would it not aid your results to use subjects whose hair loss is already progressed but no longer aggressive ? This would give you better looking results.

----------


## xyz123

> Just one question , 
> 
> Is the only reason were getting excited because they're testing on higher end NW scale men? 
> 
> If I was a cynic I would suspect that they would use higher NWs as false proof of maintainance. For example, most people loose hair more rapidly between NW 2-3 than say between 4-5. So would it not aid your results to use subjects whose hair loss is already progressed but no longer aggressive ? This would give you better looking results.


 No.  Both Phase 2 trials are randomized, double-blind, placebo controlled trials.  The efficacy of both doses of SM are compared to placebo (ie. the vehicle alone).  In the event that all study participants had completely stopped losing their hair, the drug would appear no better than vehicle alone - and hence the studies would be negative. 

If the studies are positive, it means that the study participants receiving the real SM grew more hair than participants receiving placebo (vehicle alone) in just 3 months.

----------


## Dimoxynil

^
Cheers mate, excellent response

----------


## nameless

> Agreed - though I don't think the battle is over after new hair follicles are created - the new follicles are unlikely to be 100% consistent with regular follicles - and there will be years of working on making them cosmetically acceptable, ensuring they regenerate after they fall out, and then there's the issue that they might be androgen sensitive and maintenance drugs will still be required...
> 
> That said - and to keep this thread on topic - after some more thought, I am 99% positive that the SM trial was positive - and believe it or not, this isn't just mental mast.rbation 
> 
> I'm involved in clinical trials in another area of medicine (that actually gets NIH funding...) and just realized - you canNOT conduct a clinical trial in humans when you know that the result is going to be negative - i.e. the notion of FUTILITY.
> 
> When you do a study in humans with an experimental drug and the result is negative - you can't go back to the FDA and say - "yeah, the drug doesn't work - but we'd like to gather some more information to find out why.  So would you mind if we ran another trial - it will just be another 50 people and this time we'll take scalp biopsies".  
> 
> It doesn't work like that - with animals, there's no problem with giving an ineffective drug to another 50 mice to gather more data to try and understand why.  But you can't do that with humans - to conduct another trial, you would have to change something about the protocol and provide justification why you think it will work this time (which usually means going back to the lab and generating additional data).  And that's not the case here - the protocol for both of the SM Phase 2 trials are COMPLETELY IDENTICAL.
> ...


 I also do not believe that the FDA would allow a company to go on a fishing expedition on human beings to find out why a drug did not work. I could be wrong but I don't think so.  And I do believe that the FDA would  have been involved in setting up the additional phase 2 study and I think that the additional phase 2 study is probably set-up to get the company the necessary bio-markers to avoid a phase 3 trial.

----------


## nameless

> Pure speculation - but I would guess 1-3 year range.
> 
> If the 21st century cures act passes and applies to this drug, I think it could come to market in late 2016.
> 
> If the FDA still requires a Phase 3 trial, I think it will be 2018.  The Phase 3 trial will start in mid to late 2016 (there won't be delays - assuming the drug works, everyone and their grandmother will want to invest in this company), will last ~ 1 year, and then the FDA review will take 3-9 months.
> 
> That's my guess.  No way it takes 5 years if the drug truly works like we hope/think it will.


 
How can we invest in this company?

I think there will be a minimum amount that you have to invest. For example, a person might have to invest at least $25,000 or $50,000 or something like that. I don't happen to have that kind of money sitting around. 

Perhaps we could form a group of us to each put in a certain amount of money so that we can collectively reach the minimum amount needed to invest.

----------


## nameless

> Just one question , 
> 
> Is the only reason were getting excited because they're testing on higher end NW scale men? 
> 
> If I was a cynic I would suspect that they would use higher NWs as false proof of maintainance. For example, most people loose hair more rapidly between NW 2-3 than say between 4-5. So would it not aid your results to use subjects whose hair loss is already progressed but no longer aggressive ? This would give you better looking results.


 I really don't think so.

----------


## joel203

would SM work for maintenance as well as regrowth?

----------


## nameless

> would SM work for maintenance as well as regrowth?


 How are we supposed to know the answer to this question with certainty? We are not company spokespersons.

----------


## JayM

If it works, yes.

----------


## nameless

> Damn! you are right my friend, it's a clear possibility 
> 
> I wasn't aware of that! I was believing that elimination of phase 3 would be ONLY for rare and serious diseases but I was wrong! thank you dude you made my day 
> 
> its also said here : 
> http://www.collective-evolution.com/...eard-about-it/
> 
> "The 21st Century Cures Act allows drugs to be rushed to the market, removes phase 3 testing as a requirement for drug approval, bases drug approval on biomarkers rather than actual health outcomes"
> 
> ...


 
On second thought I doubt if the FDA would allow a human study (putting
humans at risk) that would satisfy the requirements of a pending legal bill 
that is not yet law.

----------


## xyz123

> On second thought I doubt if the FDA would allow a human study (putting
> humans at risk) that would satisfy the requirements of a pending legal bill 
> that is not yet law.


 I'm sure neither side explicitly stated that was the reason for the second trial - but Samumed undoubtedly knows it's likely to be passed (industry/biotech is one of the major drivers for this act).  So, in the event that it does get passed, why not run a relatively small and quick trial to acquire the necessary biomarker data that would lead to earlier approval.  They're not really losing any time and the additional cost could be well worth it.

Given that the drug appears safe - and presumably effective - the FDA won't say no to this.  More data in terms of patient outcomes and the drug's mechanism of action is never a bad thing.  I'm sure the FDA would happily approve the trial on that basis (while at the same time, knowing in the back of their minds that the major reason Samumed probably wants the trial - although not explicitly stating it - is to potentially avoid a Phase 3 trial and pursue earlier approval in the event that the act is approved).

----------


## nameless

> I'm sure neither side explicitly stated that was the reason for the second trial - but Samumed undoubtedly knows it's likely to be passed (industry/biotech is one of the major drivers for this act).  So, in the event that it does get passed, why not run a relatively small and quick trial to acquire the necessary biomarker data that would lead to earlier approval.  They're not really losing any time and the additional cost could be well worth it.
> 
> Given that the drug appears safe - and presumably effective - the FDA won't say no to this.  More data in terms of patient outcomes and the drug's mechanism of action is never a bad thing.  I'm sure the FDA would happily approve the trial on that basis (while at the same time, knowing in the back of their minds that the major reason Samumed probably wants the trial - although not explicitly stating it - is to potentially avoid a Phase 3 trial and pursue earlier approval in the event that the act is approved).


 You know, I was thinking the exact same thing you posted but I thought that other posters would say that it sounds far-fetched. I swear it. I was thinking that Samumed may have pushed for the study because they believe that the 21st Century Cures Act might pass and they want to get biomarkers so they can eliminate the need for a phase 3 study, but they probably told the FDA that they wanted to gather more biomarker data since wnt mediation is kind of new, and deep down inside the FDA knows that Samumed is really thinking ahead to the possibility that the 21st Century Cures Act could be passed. 

I swear I was thinking this when I typed my earlier post the FDA would not allow a study based on a pending ACT that isn't law yet. Since I was thinking the same thing you stated that means I agree with your idea. I think that is what happened between the FDA and Samumed.

----------


## hellouser

> On second thought I doubt if the FDA would allow a human study (putting
> humans at risk) that would satisfy the requirements of a pending legal bill 
> that is not yet law.


 Then you'll NEVER know if it works. The whole point of finding if drugs work is to test on humans.

----------


## nameless

We need to contact our US senators and tell them to approve the 21st Century Cures Act in its' entirety, especially the part of the Act that allows drug companies to use biomarkers in lieu of phase 3 studies. We all need to jam their phone lines and send them emails.

----------


## TravisB

This might be a dumb question but why should we be excited about this?

Are there any signs that it might work? Any preliminary results?

Also, how it's supposed to work? Will it be able to regrow full head of hair? Or maintain only?

I wasn't following Sm04554 topic

----------


## JayM

> This might be a dumb question but why should we be excited about this?
> 
> Are there any signs that it might work? Any preliminary results?
> 
> Also, how it's supposed to work? Will it be able to regrow full head of hair? Or maintain only?
> 
> I wasn't following Sm04554 topic


 Then please read the topic. I know its a lot of pages but they answer your questions. Well apart from what it will be able to do. Who even knows.

----------


## nameless

> Then you'll NEVER know if it works. The whole point of finding if drugs work is to test on humans.


 
Hellouser I don't think you understood my statement. 

In any case, they already know if it works. They learnt whether or not it works from the initial phase 2 study. It's pretty obvious that it works because they're investing more money into it - moving it to an extra phase 2 means they're spending more money. It didn't die after the initial phase 2 and that should tell you something.

----------


## nameless

> This might be a dumb question but why should we be excited about this?
> 
> Are there any signs that it might work? Any preliminary results?
> 
> Also, how it's supposed to work? Will it be able to regrow full head of hair? Or maintain only?
> 
> I wasn't following Sm04554 topic


 
Read the posts like Jay said.

----------


## macbeth81

> We need to contact our US senators and tell them to approve the 21st Century Cures Act in its' entirety, especially the part of the Act that allows drug companies to use biomarkers in lieu of phase 3 studies. We all need to jam their phone lines and send them emails.


 This article makes it sound like the Senate is making their own bill based off of the 21st Century Cures Act and will not vote on the House passed bill. It states they won't be ready until next year, but the older article states by Thanksgiving. Not sure which is accurate but sounds typical of our Senate.

http://morningconsult.com/2015/07/th...ing-next-year/

http://www.nationaljournal.com/healt...-bill-20150710

----------


## It's2014ComeOnAlready

> This article makes it sound like the Senate is making their own bill based off of the 21st Century Cures Act and will not vote on the House passed bill. It states they won't be ready until next year, but the older article states by Thanksgiving. Not sure which is accurate but sounds typical of our Senate.
> 
> http://morningconsult.com/2015/07/th...ing-next-year/
> 
> http://www.nationaljournal.com/healt...-bill-20150710


 It should essentially be the same, and I know that the creator of the bill (Fred Upton) is working on it with the senate. Also, it's very likely the bill should be passed or at least voted on before the end of the year, because of 2016 being an election year.

Anyone seeking re-election will want their name on that bill. It is extremely popular among constituents.

----------


## nameless

> This article makes it sound like the Senate is making their own bill based off of the 21st Century Cures Act and will not vote on the House passed bill. It states they won't be ready until next year, but the older article states by Thanksgiving. Not sure which is accurate but sounds typical of our Senate.
> 
> http://morningconsult.com/2015/07/th...ing-next-year/
> 
> http://www.nationaljournal.com/healt...-bill-20150710


 
They're dragging their feet. We need them to vote on this thing quick.

----------


## It's2014ComeOnAlready

The more I think about it, the more the use of biomarkers for phase 3 trials makes terrific sense. Most drugs never even reach phase 3. If they've shown definite safety and effectiveness in phases 1 & 2, and if there are biomarker(s) that can determine whether or not a drug is actually having an effect on its target, then that is much more common sense than what the current rules are. 

Phase 3 trials are the most expensive to run due to their size, duration etc. If a company cannot continue to fund a drug that is safe, effective, and could otherwise prove that it is a targeted therapy, then all the FDA is doing in this case is stifling innovation. 

For these reasons, I also believe a drug like setipiprant, which has already had a phase 3, will also be sped up. They would only need to determine whether or not the drug is reducing PGD2 levels in the scalp, along with scalp biopsies to determine the change in the number of hairs in an anagen state. 

I don't believe in God, but God bless the politicians, medical professionals, and venture capitalists who are responsible for this bill lol

----------


## JayM

Is there a date it has to be passed into law/not passed by?

----------


## lacazette

Look at this:

Angela Christiano, Ph.D.

Hair-Loss Treatment with Hair-Loss Gene Promotes New Hair Growth, Regulates Male-Pattern Baldness 

The discovery of the APCDD1 gene, which causes hair loss, has potential for future male-pattern baldness treatments, and for regulating male and female hair growth, density of hair, and hair graying. 

the APCDD1 gene inhibits the Wnt signaling pathway 

Laboratory researchers have targeted this Wnt pathway to turn on or off hair growth in mice, but until now, the pathway did not appear to be involved in human hair loss. Their findings provide evidence that hair-growth patterns in humans and in mice are similar, and they suggest for the first time that manipulating the Wnt pathway may have an effect on human hair-follicle growth.

Unlike commonly available hair loss treatments that involve blocking hormonal pathways, treatments involving modulation of the APCDD1 gene and the Wnt pathway would be non-hormonal, which may enable many more people suffering from hair loss to receive such therapies

Advantages:
•Surgical treatment options for hair loss require multiple costly procedures. This technology represents a way to modulate hair growth without the need of surgery as APCDD1 represents a potential drug target.
•Targeting APCDD1 will not only prevent further hair loss but has the potential to grow new hair, in contrast to current medical alternatives.
"

http://innovation.columbia.edu/techn...d-graying-hair

So it's seems there's two ways: inhibit APCDD1 
                              or upregulate the pathway that is inhibited by this gene ( samumed  :Smile:  )

Samumed patented their Wnt pathway activators in 2011 http://www.google.com.na/patents/EP2605652A1?cl=un

----------


## seanway

So how to fight APCDD1 ? sm04554 ?

----------


## lacazette

It's been 4 years, so I think she didn't found for the moment a topically safely way to inhibit this gene with a molecule

Whereas samumed have the safely molecule to activate the wnt pathway

So yes I think SM04554 will make our Wnt signaling pathway come back to his normal activity. The gene inhibit the pathway but we will upregulate this pathway daily. So I really think that SM will stop (or slow for years) the hair loss, and even more activation will give regrowth. But abberant activation give skin cancer, so they have to be careful. 
But our Wnt signaling pathway is inhibited right now, so we just need an upregulation that lead to his normal activity, so it's far from cancer aberrant activity i think

----------


## seanway

But if we use something topically with low half life it should be a matter of concern isnt ? I hope SM04554 will have nice result.

----------


## lacazette

Well they used it once daily in the trials, so let's hope their level activation is strong enough. Maybe severe hair loss sufferers will be able to use it twice daily ^^

In mouse just one topical Wnt activation induced anagen phase of the HFs, whereas 6 applications not only induce anagen phase, but also lead to ectopic HF formation from existing ones. 


another study mentioning Wnt, 2014

The Wnt/β-catenin pathway plays an important role in the initiation, development, and growth of hair follicles.
The transient activation of β-catenin results in hair regrowth in mice, while ablation of β-catenin results in dramatic hair shortening and abnormal regeneration of hair in the dermal papilla of mouse hair follicles [19, 33]. The levels of β-catenin in the dermal papilla are high in the anagen phase but low in the catagen and the telogen phases [18, 34]. Furthermore, the interaction between β-catenin, androgen receptors, and keratinocyte growth inhibition through modification of Wnt signaling contributes to androgenic alopecia, a common form of hair loss

----------


## champpy

I read earlier in this thread that Samumed is the 3rd largest sponsor of the Hair Conference.  Can anyone tell me if this is their first time as a sponsor?  Also, who are the other two sponsors that are ahead of Samumed? 

If this is their first time, and they have a large presence, this tells me that they may actually have something they want to announce.

----------


## xyz123

> I read earlier in this thread that Samumed is the 3rd largest sponsor of the Hair Conference.  Can anyone tell me if this is their first time as a sponsor?  Also, who are the other two sponsors that are ahead of Samumed? 
> 
> If this is their first time, and they have a large presence, this tells me that they may actually have something they want to announce.


 First time they've been a sponsor.  And Women's Rogaine and Procter & Gamble are the top 2.

http://www.hair2015.org/

----------


## nameless

We should be contacting our US senators and asking them to rush approve the 21st Century Cures Act. Anyone who does not do this is not helping to overcome baldness. Anyone who does not do this is a slacker who does what he can to contribute to the cause of defeating baldness.

----------


## nameless

> First time they've been a sponsor.  And Women's Rogaine and Procter & Gamble are the top 2.
> 
> http://www.hair2015.org/


 
Proctor and Gamble does not even have a respected treatment for hair loss. 

What a bunch of jerks.

----------


## failly

I have found two interesting articles coming from 2013. Don't know if these links are already posted.

http://www.uphs.upenn.edu/news/News_...013/12/millar/

http://www.nature.com/jid/journal/v1...d2012446a.html

----------


## champpy

While they may not have a respected treatment, P&G a huge company. Rogaine (while absolute poo in my mind) is a household name. 

I really cannot think of any other reason why Samumed would be such a large sponsor if they didn't have something they are trying to promote. Am I wrong on this? If I am, can someone please tell me why else they would be part of the conference ?

----------


## champpy

While they may not have a respected treatment, P&G a huge company. Rogaine (while absolute poo in my mind) is a household name. 

I really cannot think of any other reason why Samumed would be such a large sponsor if they didn't have something they are trying to promote. Am I wrong on this? If I am, can someone please tell me why else they would be part of the conference ?

----------


## nameless

> While they may not have a respected treatment, P&G a huge company. Rogaine (while absolute poo in my mind) is a household name. 
> 
> I really cannot think of any other reason why Samumed would be such a large sponsor if they didn't have something they are trying to promote. Am I wrong on this? If I am, can someone please tell me why else they would be part of the conference ?


 
I agree with you. I don't think Samumed would waste time and other resources on the Hair Loss Congress if their product isn't a significant improvement over the existing treatments (propecia, dutasteride, and Rogaine).

----------


## maver1ck

> While they may not have a respected treatment, P&G a huge company. Rogaine (while absolute poo in my mind) is a household name. 
> 
> I really cannot think of any other reason why Samumed would be such a large sponsor if they didn't have something they are trying to promote. Am I wrong on this? If I am, can someone please tell me why else they would be part of the conference ?


 Common sense would say yes, they have something to promote so they obviously spend what money they can to get the 3rd sponsorship spot. We KNOW they have something, but we just dont know how effectively it works. With that being said why promote yourselves when you know your product doesn't even work? If we can believe those people on this thread with knowledge of clinical trials (and I dont really see why any laymen shouldnt) then there really is something to the second round of testing and maybe they will make a full scale announcement.

----------


## lacazette

> Proctor and Gamble does not even have a respected treatment for hair loss. 
> 
> What a bunch of jerks.


 You're right dude, but they are supporting several labs research like this one for example in Southampton university, so not surprising to see they are a sponsor of the event:

http://www.ngcm.soton.ac.uk/projects...mechanics.html

Microstructural modelling of skin mechanics

"The project aims to gain a mechanistic insight into the biomechanics of the skin, particularly around hair follicles via the development of advanced multiscale constitutive equations and micromechanical models integrated into a multiphysics finite element environment.

The project is supported by Procter&Gamble
the results of the PhD project have the potential to impact the life of hundreds of millions of male and female consumers across the globe."

----------


## Renee

Didn't aderans do a phase 2b to take punch biopsies like sm is doing now? Look at what happened to them.

----------


## macbeth81

If I am not mistaken Aderans had multiple, smaller Phase 2 trials to test different protocols. They were doing trial/error approach to see what worked (nothing). For SM04554 the two Phase 2 trials use the same protocol, but the second one is taking biopsies (pre/post application). They didn't take biopsies at the beginning of the initial trial, thus they need to start the trial over to get the initial, pre-treatment biopsies.

----------


## champpy

> We KNOW they have something, but we just dont know how effectively it works. With that being said why promote yourselves when you know your product doesn't even work?


 Thats a question id love to ask the makers of rogaine

----------


## bigentries

> Common sense would say yes, they have something to promote so they obviously spend what money they can to get the 3rd sponsorship spot. We KNOW they have something, but we just dont know how effectively it works. With that being said why promote yourselves when you know your product doesn't even work? If we can believe those people on this thread with knowledge of clinical trials (and I dont really see why any laymen shouldnt) then there really is something to the second round of testing and maybe they will make a full scale announcement.


 Just so people get it into context. Aderans had the same sponsorship in the last congress

http://www.hair2014.org/Contents.asp...13&openpage=13

----------


## Renee

I don't understand why intercytex & aderans shut down after spending all that money. They still have access to a lot of capital and could of continued doing research. Closing shop and moving on seems to me they had no hope of finding the cure.

----------


## It's2014ComeOnAlready

This is a thread about SM. If you want to talk about intercyx and aderans, then go start a new thread and take that crap over there.

----------


## Renee

Control your attitude and relax. Instead of writing that dumb response answer the question.

----------


## It's2014ComeOnAlready

> Control your attitude and relax. Instead of writing that dumb response answer the question.


 I'm perfectly relaxed. Didn't know you could read emotions and minds through the internet. It's not a dumb response, because in fact, these programs have nothing to do with one another. 

That guy "bigentries" always compares everything to intercyx and aderans just to derail real discussion of facts, and to bring the conversation down because he is miserable. You cannot tell him anything. So, instead of having the convo dragged down (because misery loves company) over irrelevant comparisons, go start a new thread.

----------


## Renee

Instead of putting the time to write these two irrelevant responses to this topic you could have commented on what I wrote and possibly contributed something productive and positive.

----------


## lacazette

> I don't understand why intercytex & aderans shut down after spending all that money. They still have access to a lot of capital and could of continued doing research. Closing shop and moving on seems to me they had no hope of finding the cure.


 Intercytex abandoned its work in 2010 due to financial difficulties

For aderans, look their presentation's videos, you will clearly see how it was basic science with poor knowledge/technologies, compared of what we're talking about now (3D, bioenginereed,stem cells,..)
http://www.hairlosscure2020.com/less...tion-failures/

Their idea sounded good, but unfortunately the reality is far more complicated.


To come back on Samumed, I saw articles who explains how bad the 21st cure bill will be, blablabla
Is there an anti-bill mouvement in US? 
The senators are old in US too right?  :Smile:  if so many of them are concerned with diseases so i'm optimistic lol

----------


## lacazette

> Just so people get it into context. Aderans had the same sponsorship in the last congress
> 
> http://www.hair2014.org/Contents.asp...13&openpage=13


 It was already a wig company at that time lol

----------


## nameless

I'm so looking forward to the coming hair loss congress. There are at least 2 projects (SM04554 & iPS cells) for a major breakthrough. I think that 2015 will go down in history as the year that a cure for hair loss is announced at a hair loss Congress. The battle is won and now it's just a matter of getting the treatment(s) to market. And I think we will start seeing those cures hit the market as soon as late 2016 or early 2017, if the 21st Century Cures Act is approved by the senate in the same form as the US House of Congress approved this past July. 

I also think that all of the things they're learning about cells will lead them to reversing the entire aging process within just a few years. They are getting closer and closer to total rejuvenation of the entire human body.

----------


## joachim

> I'm so looking forward to the coming hair loss congress. There are at least 2 projects (SM04554 & iPS cells) for a major breakthrough. I think that 2015 will go down in history as the year that a cure for hair loss is announced at a hair loss Congress. The battle is won and now it's just a matter of getting the treatment(s) to market. And I think we will start seeing those cures hit the market as soon as late 2016 or early 2017, if the 21st Century Cures Act is approved by the senate in the same form as the US House of Congress approved this past July. 
> 
> I also think that all of the things they're learning about cells will lead them to reversing the entire aging process within just a few years. They are getting closer and closer to total rejuvenation of the entire human body.


 hmm... i think the cure could indeed be already somewhere out there, but they won't announce anything cure-like at the congress. they are all just dancing around there, holding back important information and discussing irrelevant hair transplant topics.

let's see, but i'm prepared to be dissapointed again.

----------


## Sogeking

> hmm... i think the cure could indeed be already somewhere out there, but they won't announce anything cure-like at the congress. they are all just dancing around there, holding back important information and discussing irrelevant hair transplant topics.
> 
> let's see, but i'm prepared to be dissapointed again.


 Yup. Its basically bunch of scientists validating each others work and confirming previously known stuff through new research which is a small incremental improvement on the aforementioned previous work. Basically a circlejerk.

We'll find out nothing.

----------


## lacazette

Just saw that Samumed was one of the two sponsors ( with Procter & gamble) of the North American Hair Research Society
Scientific Meeting  8 may 2015

http://nahrs.org/Portals/0/meetings_...ID_2015_v2.pdf  (bottom page)

----------


## Renee

Shisheido recently declared they have the cure by 2018 via ips cells. If you look at the video by replicel from a few weeks back part 2 it shows dr ohyama doing research with ips cells. According to my online research dr ohyama now works with/for shisheido. So it's safe to say shisheido is doing research with ips cells and they probably have it figured out, hence the cure claim in 2018. I wonder about the safety but I'm no ipsc expert, shisheido may have figured that out also. 

The real interesting research is drs Linder/lauster/atac & drs christiano/jahoda/Higgins. These researchers are very close and their method is safe for humans. If you look at the tissuse website it says 2013 "TissUse has also, at the same time, received an exclusive license for a promising cell therapy to combat hair loss, which was developed by the same department of the TU Berlin. “We are carrying out first clinical testing of this therapy with hair transplant centres worldwide,” said Marx."

----------


## failly

When will the senate choose to pass or deny the 21st Century Cures Act?
I am not from America so I have little information about the proces.

----------


## burtandernie

I still think its a pretty dangerous game to play by throwing around a word like cure. Just seems a bit premature and overly optimistic to me until we see some more concrete proof its actually working and pretty much a done deal. It still sounds like a work in progress and pretty much a complete guessing game when or if it will happen.

----------


## hellouser

> I still think its a pretty dangerous game to play by throwing around a word like cure. Just seems a bit premature and overly optimistic to me until we see some more concrete proof its actually working and pretty much a done deal. It still sounds like a work in progress and pretty much a complete guessing game when or if it will happen.


 Tell that to the clickbait journalists.

----------


## It's2014ComeOnAlready

Senate's thoughts re 21st Century Cures Act reforms

http://www.help.senate.gov/imo/media..._Americans.pdf

good to see they are on the same page as congress. This was from awhile ago, but it goes very much into detail what congress has outlined.

----------


## GSD

New trial? https://clinicaltrials.gov/ct2/show/...sm04554&rank=1

----------


## JayM

> New trial? https://clinicaltrials.gov/ct2/show/...sm04554&rank=1


 Just scroll back a few pages.

----------


## burtandernie

> Tell that to the clickbait journalists.


 Yeah like the PGD 2 news. There were stories saying MPB will be cured in 2 years. Granted Seti might come out someday and we will see something from that, but its been more than 2 years already. I mean 2 years was a completely made up arbitrary number.

----------


## lacazette

So what's the news regarding 21st cure bill? when does the senate will vote, still an unknown date? 

This act has to pass, like that even if Samumed have to do a phase 3, it will be a little one with multiple biomarkers instead or a large long one. 

we need to activate our wnt pathway!!!

----------


## nameless

> So what's the news regarding 21st cure bill? when does the senate will vote, still an unknown date? 
> 
> This act has to pass, like that even if Samumed have to do a phase 3, it will be a little one with multiple biomarkers instead or a large long one. 
> 
> we need to activate our wnt pathway!!!


 Posters need to contact their US senators and insist that the senators pass the bill in the same form that the house passed it.

----------


## It's2014ComeOnAlready

> So what's the news regarding 21st cure bill? when does the senate will vote, still an unknown date? 
> 
> This act has to pass, like that even if Samumed have to do a phase 3, it will be a little one with multiple biomarkers instead or a large long one. 
> 
> we need to activate our wnt pathway!!!


 http://morningconsult.com/2015/07/th...ing-next-year/

Last post! lol check the pdf I posted a page or so back, this is the same senator who is working on the bill, he definitely gets the idea.

----------


## lacazette

Oh thnaks dude, my bad :Wink: 

So it sounds good:

"“I think it’s fair to say that I think this is a train that will actually get to the station,” 

The chamber will pass its own version in 2016 (in the beginning I hope)

"We’re working on a similar bill on a parallel track — not the same bill, a similar bill.”  
please don't scare me, they won't change the phase3/biomarkers thing right?

----------


## It's2014ComeOnAlready

> Oh thnaks dude, my bad
> 
> So it sounds good:
> 
> "“I think it’s fair to say that I think this is a train that will actually get to the station,” 
> 
> The chamber will pass its own version in 2016 (in the beginning I hope)
> 
> "We’re working on a similar bill on a parallel track — not the same bill, a similar bill.”  
> please don't scare me, they won't change the phase3/biomarkers thing right?


 No, I doubt that is taken out. If you note from the article, it explicitly states that they're interested in getting meds in to the medicine cabinet more quickly, and at lower cost. You cannot avoid altering phase 3 studies if you want to do that, because that's the longest trial that costs the most money. 

Also, it states that they are not interested in lowering safety standards, but rather adding and using more information. Biomarkers for phase 3's are use of more information imo. 

LAST POST! lol enjoy the rest your summer, guys.

----------


## lacazette

yeah sorry man :P i read it too speedly your right, we will be able to say goodbye of the old long phase 3 soon

"Alexander said his goal for the legislation “is to try to align federal policies in such a way that we’re able to move discoveries through the entire process of innovation, regulation and investment into the medicine cabinet more rapidly and at lower cost.”

But maybe samumed will do a normal phase 3, cause if the senate pass his own version in middle/ late 2016, then add the time for the laws to take place effectively, , it will take some time
samumed could already begin in late 2015 a big phase 3 for another year and then the 21st cure bill will at least accelerate the phase 4 fda approval

----------


## champpy

I was looking over the page on clinical trials concerning SM and saw that one of their secondary objectives is to have the patients fill out a document on how hair loss affects their life.
Is this normal for when they do hair loss trials? 

Idk, but if its not normal, to me it sounds as if they are gathering more data that could be used to help promote the product. Which, isnt that something they might do if its nearing release?

"X amount of men say hair loss negatively affects their quality of life.....buy our product"

----------


## dus

> I was looking over the page on clinical trials concerning SM and saw that one of their secondary objectives is to have the patients fill out a document on how hair loss affects their life.
> Is this normal for when they do hair loss trials? 
> 
> Idk, but if its not normal, to me it sounds as if they are gathering more data that could be used to help promote the product. Which, isnt that something they might do if its nearing release?
> 
> "X amount of men say hair loss negatively affects their quality of life.....buy our product"


 Could be to assist with FDA approval. The mental health issues surrounding hair loss are hardly known or understood by those who do not suffer hair loss.

----------


## Justinian

> Could be to assist with FDA approval. The mental health issues surrounding hair loss are hardly known or understood by those who do not suffer hair loss.


 This is true. It is known that the 21st Century Cures act is supposed to add patient experience data as a valid metric for considering approval. 

What I want to know is why they are doing it for SM04554. This tells me one of two things: The numerical data may be insufficient and they want to supplement it with patient data to ensure approval. Or that they may be able to get some sort of accelerated approval for SM04554 before or during Phase 3. Their Phase 2 had an unusually large number of patients. The 21st century cures act hints at accelerated approval without a phase 3, but mostly for treatments of life threatening diseases.

----------


## nameless

> This is true. It is known that the 21st Century Cures act is supposed to add patient experience data as a valid metric for considering approval. 
> 
> What I want to know is why they are doing it for SM04554. This tells me one of two things: The numerical data may be insufficient and they want to supplement it with patient data to ensure approval. Or that they may be able to get some sort of accelerated approval for SM04554 before or during Phase 3. Their Phase 2 had an unusually large number of patients. The 21st century cures act hints at accelerated approval without a phase 3, but mostly for treatments of life threatening diseases.


 
WTF?!?

The 21st Century Cures Act does not say "There should be an accelerated approval process but mostly for life-threatening treatments." What a joke! An act would never say something so vague is unspecific. 

The 21st Century Cures Act allows for the elimination of phase 3 studies for almost all treatments.

----------


## JayM

To be fair though it was a good spot with that they include patient experience data. It just adds to the fact this might be what they are after.

----------


## xyz123

> This is true. It is known that the 21st Century Cures act is supposed to add patient experience data as a valid metric for considering approval. 
> 
> What I want to know is why they are doing it for SM04554. This tells me one of two things: The numerical data may be insufficient and they want to supplement it with patient data to ensure approval. Or that they may be able to get some sort of accelerated approval for SM04554 before or during Phase 3. Their Phase 2 had an unusually large number of patients. The 21st century cures act hints at accelerated approval without a phase 3, but mostly for treatments of life threatening diseases.


 I really don't think they are missing their numbers.  This second study with scalp biopsies has more ambitious endpoints than the first trial (and correct me if I'm wrong - but the hair growth questionnaire was filled out in the first trial - not the second? ).

These more ambitious endpoints are with just 50 patients - so ~ 17 in each group.  They know how the drug is going to perform in this second Phase 2 based on the first Phase 2 - and I'm sure they based their sample size in the second study based on the results of the first.  A smaller study indicates that they anticipate hitting these endpoints without needing as many participants - ie. the drug has a large effect size so fewer participants required to show statistical significance.  If the drug didn't work, they would be setting themselves up for failure in the second Phase 2 study - and no company does that - they would either go back to the drawing board or move on.

Everything points to SM04554 being a success.

----------


## nameless

> I really don't think they are missing their numbers.  This second study with scalp biopsies has more ambitious endpoints than the first trial (and correct me if I'm wrong - but the hair growth questionnaire was filled out in the first trial - not the second? ).
> 
> These more ambitious endpoints are with just 50 patients - so ~ 17 in each group.  They know how the drug is going to perform in this second Phase 2 based on the first Phase 2 - and I'm sure they based their sample size in the second study based on the results of the first.  A smaller study indicates that they anticipate hitting these endpoints without needing as many participants - ie. the drug has a large effect size so fewer participants required to show statistical significance.  If the drug didn't work, they would be setting themselves up for failure in the second Phase 2 study - and no company does that - they would either go back to the drawing board or move on.
> 
> Everything points to SM04554 being a success.


 You could be wrong but if you are then so am I because I concur with you. I also think that the fact that they have only 50 people in their additional phase 2 indicates that they expect a high rate of success or else they would have involved more subjects.

----------


## lacazette

What about the asian market? Maybe Samumed is planning something there also, if they have to do a phase 3

And in japan the approval process is also quicker for new drugs

"Japan’s Pharmaceuticals and Medical Devices Agency was quicker to approve more new drugs in 2014 than its U.S. and EU counterparts, according to a new study released by the Centre for Innovation in Regulatory Science."

Maybe this second phase2 with biomarkers could be sufficient to ask fir approval procedure in japan, or maybe just the need of a little phase 3 with more biomarkers.
I think there's a possibility that samumed will hit the asian market sooner than in US/Europe

----------


## failly

> What about the asian market? Maybe Samumed is planning something there also, if they have to do a phase 3
> 
> And in japan the approval process is also quicker for new drugs
> 
> "Japans Pharmaceuticals and Medical Devices Agency was quicker to approve more new drugs in 2014 than its U.S. and EU counterparts, according to a new study released by the Centre for Innovation in Regulatory Science."
> 
> Maybe this second phase2 with biomarkers could be sufficient to ask fir approval procedure in japan, or maybe just the need of a little phase 3 with more biomarkers.
> I think there's a possibility that samumed will hit the asian market sooner than in US/Europe


 Why would a company want a faster approval by going to Japan? Even though it may be approved, the FDA will still do their own work, which takes some years.

Even if a treatment(speaking of all, not only hairloss) gets approved by the FDA, people in Europe will still be waiting some years till they get it. I think every big country or continent does it's own testing, even though it is approved in other countries.

----------


## SriHanuman

> Why would a company want a faster approval by going to Japan? Even though it may be approved, the FDA will still do their own work, which takes some years.
> 
> Even if a treatment(speaking of all, not only hairloss) gets approved by the FDA, people in Europe will still be waiting some years till they get it. I think every big country or continent does it's own testing, even though it is approved in other countries.


 That is not true, they take around 6 months to approve drugs already approved by other regulatory bodies. There is a drug lag, but not in years. Read this:

The Speeding Access to Already Approved Pharmaceutical Actwould accelerate the review process by requiring FDA to review any drug approved for use in the EU in just 90 days—far more quickly than FDA's current fastest assessment, which takes six months (priority review designation). - See more at: http://www.raps.org/Regulatory-Focus....yTErdaPY.dpuf

----------


## failly

> That is not true, they take around 6 months to approve drugs already approved by other regulatory bodies. There is a drug lag, but not in years. Read this:
> 
> The Speeding Access to Already Approved Pharmaceutical Actwould accelerate the review process by requiring FDA to review any drug approved for use in the EU in just 90 daysfar more quickly than FDA's current fastest assessment, which takes six months (priority review designation). - See more at: http://www.raps.org/Regulatory-Focus....yTErdaPY.dpuf


 Good to hear it's faster the other way. However, it states "for use in the EU". I was talking about a drug that has been approved in the US coming to the EU will take years. I don't know if it's true though, I heard it on the news some days ago about another drug.

----------


## SriHanuman

Yes, it is true you were talking about US -> EU but I thought that it is the same timeline, or at least I hoped so. Then I found this: http://www.ncbi.nlm.nih.gov/pubmed/26013294

----------


## dus

If needed us Europeans will arrange a ****ing submarine and stuff it with Sm04554. Or I'll just do a couple of plane trips  :Stick Out Tongue: .

----------


## lacazette

> Why would a company want a faster approval by going to Japan? Even though it may be approved, the FDA will still do their own work, which takes some years.
> 
> Even if a treatment(speaking of all, not only hairloss) gets approved by the FDA, people in Europe will still be waiting some years till they get it. I think every big country or continent does it's own testing, even though it is approved in other countries.


 What I meant is that they could maybe have enough data to have approval in japan and hit the asian market. But of course they would still continue the FDA process normally for US approval. But like that we could buy by internet some SM from asia before US/Europe approval. They just need a partnership with a japan pharma company, and commercialisation would not take that long there

If they can have japan's approval sooner, I don't see why they would wait the fda approval to hit the asian market

----------


## failly

> What I meant is that they could maybe have enough data to have approval in japan and hit the asian market. But of course they would still continue the FDA process normally for US approval. But like that we could buy by internet some SM from asia before US/Europe approval. They just need a partnership with a japan pharma company, and commercialisation would not take that long there
> 
> If they can have japan's approval sooner, I don't see why they would wait the fda approval to hit the asian market


 Didn't thought about that. That is indeed true. But the price will skyrocket, since the demand is so high from both the US and the EU. Atleast it's something!

----------


## rdawg

This is getting close to completion isn't it? I thought it was done by around November?

will be very interesting to see the results.

----------


## Tomtom21

I really feel that samumed has got a product that at the very least will be an additional to add to our arsenal. I was looking at their additional round of phase 2 study with the punch biopsy. I was curious to see what exactly they were looking to evaluate from the tissue biopsy in terms of biomarkers. straight from the clinical trials page they are aiming to evaluate the following:

Change in nuclear expression of beta-catenin
Change in nuclear expression of Ki-67 in epidermis and hair follicles.
Change in Ki-67 index in epidermis and hair follicles

First off beta catenin, I believe we all understand at this point if we follow the thread that it has direct affect on wnt pathway and therefore blah blah blah. Basically it can be very important in reactivating our dead beat hair follicle cells that don't want to do their job anymore. 
However, I was curious to look into the Ki-67 biomarker they were interested in. I looked at what exactly Ki-67 protein is for and straight from wikipedia:

"The Ki-67 protein (also known as MKI67) is a cellular marker for proliferation.[5] It is strictly associated with cell proliferation. During interphase, the Ki-67 antigen can be exclusively detected within the cell nucleus, whereas in mitosis most of the protein is relocated to the surface of the chromosomes. Ki-67 protein is present during all active phases of the cell cycle (G1, S, G2, and mitosis), but is absent from resting cells (G0)"

(G0) is = senescent phase where nothing is happening. Whereas previous studies have shown that our hair follicle cells experience longer and longer phases of G0 and shorter phases of interphase and mitosis, until ultimately permanently senescent and unfortunately slick bald. 

All this coupled with the fact they recruited high norwoods, had a huge first phase 2 study, decided to run another smaller phase 2 study with biomarker biospy evaluation simultaneously with their first phase 2 study, and are evaluating these biomarkers which are directly linked to cell proliferation seem to all point to a positive opposed to a negative. Of course this is all speculative and we will have to wait a few more months to see just exactly the results are.

----------


## JayM

> I really feel that samumed has got a product that at the very least will be an additional to add to our arsenal. I was looking at their additional round of phase 2 study with the punch biopsy. I was curious to see what exactly they were looking to evaluate from the tissue biopsy in terms of biomarkers. straight from the clinical trials page they are aiming to evaluate the following:
> 
> Change in nuclear expression of beta-catenin
> Change in nuclear expression of Ki-67 in epidermis and hair follicles.
> Change in Ki-67 index in epidermis and hair follicles
> 
> First off beta catenin, I believe we all understand at this point if we follow the thread that it has direct affect on wnt pathway and therefore blah blah blah. Basically it can be very important in reactivating our dead beat hair follicle cells that don't want to do their job anymore. 
> However, I was curious to look into the Ki-67 biomarker they were interested in. I looked at what exactly Ki-67 protein is for and straight from wikipedia:
> 
> ...


 I'm excited by it as well. I guess the thing is though they could just be doing this because they saw sweet F all. Like see if the drug is actually doing anything haha. 

I dunno. I'm not so strong on scientific methods but maybe with such a huge group for phase 2 it was easier to do a separate phase 2 for biopsies if it actually did work. To be fair maybe you can't even go to phase 3 without this information even If you see hair growth. 

They better say something in November!

----------


## champpy

that's one thing that makes me really nervous, them not saying anything in November and we have to wait again just like we are waiting for bimatoprost

----------


## Swooping

> I really feel that samumed has got a product that at the very least will be an additional to add to our arsenal. I was looking at their additional round of phase 2 study with the punch biopsy. I was curious to see what exactly they were looking to evaluate from the tissue biopsy in terms of biomarkers. straight from the clinical trials page they are aiming to evaluate the following:
> 
> Change in nuclear expression of beta-catenin
> Change in nuclear expression of Ki-67 in epidermis and hair follicles.
> Change in Ki-67 index in epidermis and hair follicles
> 
> First off beta catenin, I believe we all understand at this point if we follow the thread that it has direct affect on wnt pathway and therefore blah blah blah. Basically it can be very important in reactivating our dead beat hair follicle cells that don't want to do their job anymore. 
> However, I was curious to look into the Ki-67 biomarker they were interested in. I looked at what exactly Ki-67 protein is for and straight from wikipedia:
> 
> ...


 Thanks, valuable and interesting information. The consensus between many researchers is basically that senescence/cell cycle arrest and apoptosis (or combination of both) finds place in DPC. DPC size and amount modulates hair follicle size. A decline of DPC leads to a smaller hair follicle. In fact the DPC act as a master instructive niche for the whole hair follicle. 

I have once illustrated this in a picture so it gets more clear. (Please do note that this isn't the exact pathway chain but just a overall general view)



Factually this explains why AGA is so extremely heard to reverse.  A major pathway like P53 possibly sets in who is a master of diverse cellular processes and is a evolutionary ancient coordinator of stress responses. When damage is done it can literally lock down a cell for instance and keep it that way. These pathways are very complex and versatile though. P53 and P21 for instance can activate hundreds of downstream genes and have many functions.

However the beauty of a chemical like SM04554 is that while it acts directly on b-catenin (wnt pathway) it might actually crosstalk with major regulatory pathways like P53 and other major regulatory pathways.  

Purely looking at it from a theoretical perspective is that it could work really good in my opinion. Furthermore we have no observational evidence of any direct b-catenin agonist simply because there has never been used one on humans ever. At least AFAIK.

Let's hope we will get positively surprised. Hopefully they will release their results asap.

----------


## nameless

I just tried to talk with Samumed. They're very paranoid and secretive. They won't even discuss the phase 2 that has almost completed. They did say that they do not know yet if SM04554 works or not.

----------


## nameless

> Hello all, new to the board here. 
> 
> Start this trial today (USA). The doctor is extremely encouraged by the potential of this treatment, although the clinical research nurse with whom I spoke said she hasn't witnessed much growth in the patients she has seen thus far.
> 
> We shall see.


 The study didn't even start until November 2014. Your first post is late January 2015. That means that your first post is 2 - 3 months after the study first started. I would not expect that a lot of patients would be seeing regrowth by the time you started.

----------


## nameless

> This is getting close to completion isn't it? I thought it was done by around November?
> 
> will be very interesting to see the results.


 
The study purportedly ends in October 2015.

What are the dates for the 2015 hair loss congress in Miami?

----------


## Arieux

@ nameless: Congress will be in November 18-21. (http://www.hair2015.org/) 
Samumed is one of the most important sponsors (silver).
All of that can't be only pure coincidence in my opinion.

----------


## nameless

> @ nameless: Congress will be in November 18-21. (http://www.hair2015.org/) 
> Samumed is one of the most important sponsors (silver).
> All of that can't be only pure coincidence in my opinion.


 so the first phase 2 ends about 1 month before the 2015 congress. Interesting. They could have the phase 2 results by the time the 2015 congress begins. They will at least have some preliminary data. It seems to me that they should know if the drug works by then or not.

----------


## JayM

> I just tried to talk with Samumed. They're very paranoid and secretive. They won't even discuss the phase 2 that has almost completed. They did say that they do not know yet if SM04554 works or not.


 Tbf if they aren't going to say anything then they are probably going to say that aha.

----------


## lacazette

I really believe in samumed, if it really works (like in studies with new HF formation from existing ones) even a high Norwoods will be able to undergo a big hairtransplant with a decent result
If Samumed give me my hair life back , I will tatoo them upon my heart hehe

I really hope they are planning the asian market already, and that this seconde phase 2 with biomarkers could be sufficient for a future release there (cause 'im afraid it can't be the case in US as the 21st cure bill will take months to become reality). i can't wait too long before testing this Wnt activation!

----------


## macbeth81

> I just tried to talk with Samumed. They're very paranoid and secretive. They won't even discuss the phase 2 that has almost completed. They did say that they do not know yet if SM04554 works or not.


 Shouldn't they technically *not* know if it works or not if this is a double blind study? Neither the subject or investigator should know if they received SM04554 or placebo until conclusion. 

Of course practically speaking it should be obvious if patients are returning with cosmetically visible, to the plain eye changes in hair density.

I find it surprising that they would initiate a second Phase 2 without knowing even the possibility of success. However, they do seem to be money rich. They even have their own D.C. lobbyist. I am not sure if this is common for small biotechs or not.

Lobbyist Registration

----------


## nameless

> Shouldn't they technically *not* know if it works or not if this is a double blind study? Neither the subject or investigator should know if they received SM04554 or placebo until conclusion. 
> 
> Of course practically speaking it should be obvious if patients are returning with cosmetically visible, to the plain eye changes in hair density.
> 
> I find it surprising that they would initiate a second Phase 2 without knowing even the possibility of success. However, they do seem to be money rich. They even have their own D.C. lobbyist. I am not sure if this is common for small biotechs or not.
> 
> Lobbyist Registration


 I agree with you that technically they should not know for sure if the treatment works or not, but like you said it seems like they would be able to perceive if some patients are obviously growing hair. So yes, I do think that they probably know if their drug works or not. And *if* they do know that their drug does not work then it makes no sense at all that they would waste more money on the supplemental study that they just initiated.

----------


## JayM

American guys - has there been any news on 21st century cures act?

----------


## It's2014ComeOnAlready

> American guys - has there been any news on 21st century cures act?


 Will be voted on early next year. I read an article posted yesterday, where a group of senators and congressman tied closely to the bill, speaking to a group of people, saying that they "guarantee it will become law."

----------


## JayM

Thanks 2014. Could you post the article?

----------


## hellouser

> Will be voted on early next year. I read an article posted yesterday, where a group of senators and congressman tied closely to the bill, speaking to a group of people, saying that they "guarantee it will become law."


 Why not just implement it now and stop wasting time?

----------


## It's2014ComeOnAlready

> Thanks 2014. Could you post the article?


 http://energycommerce.house.gov/icym...-hope%E2%80%9D

----------


## Tenma

Im not very familiarized with US law but find really unlikely this act will speed up clinical trials for hairloss drugs.

----------


## burtandernie

Yeah a lot of talk about this bill but no one has any clue what it will really do for specific drugs until they actually start altering timelines and there is a basis to start guessing at other ones. Right now it might not do anything at all for cosmetic drugs. No one knows. I wouldnt count on politicians or laws they pass to do much of anything in speeding up trials. Waiting on new treatments for many years is the worst part of the whole thing especially stuff like CB when there are millions of previous AAs some with similar actions to base safety off of yet 5 years to finish it? I doubt getting a topical delivery system takes that long to do. The phase 3 just kills huge amounts of time and money

----------


## joel203

> Im not very familiarized with US law but find really unlikely this act will speed up clinical trials for hairloss drugs.


 agreed

----------


## It's2014ComeOnAlready

> Yeah a lot of talk about this bill but no one has any clue what it will really do for specific drugs until they actually start altering timelines and there is a basis to start guessing at other ones. Right now it might not do anything at all for cosmetic drugs. No one knows. I wouldnt count on politicians or laws they pass to do much of anything in speeding up trials. Waiting on new treatments for many years is the worst part of the whole thing especially stuff like CB when there are millions of previous AAs some with similar actions to base safety off of yet 5 years to finish it? I doubt getting a topical delivery system takes that long to do. The phase 3 just kills huge amounts of time and money


 I don't think it's OK to speculate one way or another. You all seem to go according to your mood. The bottom line is that this law will change some protocol for clinical trials in general. They want to add information, i.e. biomarkers and surrogate endpoints. This is as much a health bill as it is an economic one. The point of the bill is also meant to keep innovation in the United States. 

Of course all of you believe hair loss will be left out. It's all I hear about on this board. How about keeping a positive outlook for once?

Enough talk, let's just wait and see.

----------


## lacazette

I read some various articles, saying that the new laws will give so much more freedom to pharma companies and that it will be very dangerous for the safety of the population. And that it would be better to stay like this without especially the suppression of the long phase 3 replaced by biomarkers,etc

So if the bill pass, I don't see why we should be afraid for hairloss drugs as the other cosmetic areas. pharma freedom is all we need. And pharma lobbies are for sure already doing their job to make this bill passed, so no worries to have i think

----------


## TooMuchHairWontKillYou

better worry about efficacy  :Wink: 

If SM fails I will get TE from depression  :Wink:

----------


## nameless

> agreed


 
I'm not 100% sure but I think you're probably wrong.  I even think that the company believes that their drug will be affected by the new law or else the company would not bother trying to secure biomarkers through their additional phase 2 study. I think there's a very real possibility that they hope to use biomarkers in lieu of a phase 3.

----------


## joel203

> I'm not 100% sure but I think you're probably wrong.  I even think that the company believes that their drug will be affected by the new law or else the company would not bother trying to secure biomarkers through their additional phase 2 study. I think there's a very real possibility that they hope to use biomarkers in lieu of a phase 3.


 I hope you're right

----------


## nameless

> I hope you're right


 
Don't misquote me. I said I'm not 100% sure.

That having been said, I do not believe that the company intended to do the supplemental phase 2 from the beginning because if they had intended to do the supplemental phase 2 all along then it seems logical that they would have done it as part of the original phase 2. They could have gotten biopsies from their subjects in the original phase 2 study. 

So this makes it look to me like this supplemental phase 2 study is something they only recently decided to do. 

So the big question is what could have prompted them to do this ad-hoc study which will produce bio-markers? I think that the logical answer to that question is that they're aware of the new FDA law that allows drug companies to use bio-markers in lieu of a phase 3 study. 

I also think that this ad-hoc study also makes it seem like they got good results in their original phase 2 study because why would they spend millions of dollars on the ad-hoc supplemental phase 2 study if they didn't see something promising in the original phase 2 study?

----------


## lacazette

Agreed nameless

And I would add that they're surely planning to hit the asian market by japan's approval

The drug approval is already easier there, and even more easier when it comes to a topical drug instead of an oral
So I suspect a second phase 2 with detailed biomarkers could be sufficient to ask for Japan's FDA approval

----------


## JayM

> Agreed nameless
> 
> And I would add that they're surely planning to hit the asian market by japan's approval
> 
> The drug approval is already easier there, and even more easier when it comes to a topical drug instead of an oral
> So I suspect a second phase 2 with detailed biomarkers could be sufficient to ask for Japan's FDA approval


 I thought Japan early release was only for stem cell therapies?

----------


## lacazette

yeah the temp approval and new legislations are for regenerative medecine BUT when it comes to drugs approval, the process is also quicker and easier in Japan than US and EU

----------


## champpy

Can anyone please answer this; if this latest SM trial is successful and they move to phase 3, how long does phase 3 for a hair loss med take? 
I heard ppl say that bim could have moved through phase 3 in 6 months...is it the same timline for SM?
Is there anyway in hell this could be available in the next year (if it works of course)?

----------


## allTheGoodNamesAreTaken

> Can anyone please answer this; if this latest SM trial is successful and they move to phase 3, how long does phase 3 for a hair loss med take? 
> I heard ppl say that bim could have moved through phase 3 in 6 months...is it the same timline for SM?
> Is there anyway in hell this could be available in the next year (if it works of course)?


 Based on how slow EVERYTHING seems to move in this business I wouldn't count on the earliest possible release date turning out to be the actual one. Just assume it's gonna take ages to get released if it works at all.

----------


## candu2015

hello it is the first time I write here but I have a lot of time reading to them.
Has anyone seen this trial about SM? https://www.anzctr.org.au/Trial/Regi...aspx?id=368801

why  this trial in australia?

----------


## bboy5

> Can anyone please answer this; if this latest SM trial is successful and they move to phase 3, how long does phase 3 for a hair loss med take? 
> I heard ppl say that bim could have moved through phase 3 in 6 months...is it the same timline for SM?
> Is there anyway in hell this could be available in the next year (if it works of course)?


 It's already available, we just don't know if it works. If the trail show's good evidence Seti works then why would you wait? Group buys and purity testing are all we need, if even that.

----------


## lacazette

Hey good find thanks Candu . The first ever trial of SM was in australia, they have facilities there
that new micro trial is interesting, it adds some safety biomarkers and seems they had choose a define protocol

Daily topical application of 0.25% (w/v) solution of SM04554 to scalp for 14 days.
SM04554 is supplied as in a non-aqueous solution of PEG400 at concentration of 0.25% weight per volume (w/v);1 vial of 0.5mL
Subject will apply at least 0.3mL of a 0.5mL study drug (SM04554) at site during visits under supervision of site staff.  


Primary outcome
To characterise pharmacokinetics of topically applied 0.25% SM04554 solution to male subjects with androgenetic alopecia, estimated using available concentration-time data for Cmax, tmax, AUC (0-24), AUC (0-infinite time) and t(1/2) from collected blood samples.
Timepoint
On treatment days 1 and 14 blood samples will be taken prior to study drug application and at 1, 2, 4, 6, 12 and 24 hours post study drug application.

On treatment days 5 and 10 blood samples will be taken prior to study drug application only.
Secondary outcome
To characterise safety and tolerability of topical SM04554 0.25% solution to scalp of male subjects with androgenetic alopecia as determined by changes from baseline in vital signs, clinical laboratory parameters and electrocardiography(ECG)
Timepoint
ECG: days 1 and 14 prior and 4 hour post study treatment
Vital signs: screening day, days 1, to 14 prior to study treatment, on days 1 and 14 at 4 and 12 hours post study treatment. ECG also performed at follow up visit day 15.
Clinical chemistry, haematology parameters and urinalysis: screening day and day 14 prior to study treatment and day 15 post study treatment
Secondary outcome
To characterise safety and tolerability of topical SM04554 0.25% solution to scalp of male subjects with androgenetic alopecia as determined by adverse events (such as skin irritation (erythema,scaling puritis, stinging) , eye irritation) and assessed by medically qualified study staff.
Timepoint
Every day from first day study drug application to day 14 and at end of study day 15.
Secondary outcome
To characterise safety and tolerability of topical SM04554 0.25% solution to scalp of male subjects with androgenetic alopecia as determined by investigator skin assessment of the scalp and hands.

----------


## candu2015

> Hey good find thanks Candu . The first ever trial of SM was in australia, they have facilities there
> that new micro trial is interesting, it adds some safety biomarkers and seems they had choose a define protocol
> 
> Daily topical application of 0.25% (w/v) solution of SM04554 to scalp for 14 days.
> SM04554 is supplied as in a non-aqueous solution of PEG400 at concentration of 0.25% weight per volume (w/v);1 vial of 0.5mL
> Subject will apply at least 0.3mL of a 0.5mL study drug (SM04554) at site during visits under supervision of site staff.  
> 
> 
> Primary outcome
> ...


 I follow with great interest this product, it's a different approach.
I am very hopeful that this treatment will come soon.
It seems they already have chosen the 0.25%?
What do you think?
I'm sorry for my English

----------


## Seuxin

I really would like to know too the timeline of this SM !

----------


## unbalding

If anyone is in Texas, Ohio, Virginia, or Michigan, they are still recruiting participants. 
https://clinicaltrials.gov/ct2/show/...ank=1#contacts

----------


## Hairmore

I cannot open the link. Seems like they closed the recruiting  since yesterday or there are just to many who were still wanted to participate very badly.

----------


## champpy

the way I'm reading this purpose portion of the clinical trial is that they're trying to understand exactly how this is working... Which may mean that it actually is working. this may be a good sign

----------


## Tenma

> the way I'm reading this purpose portion of the clinical trial is that they're trying to understand exactly how this is working... Which may mean that it actually is working. this may be a good sign


 Agreed. No way they would waste money funding another trial if the stuff is performing poorly.

What intrigues me is how effective is SM.

----------


## unbalding

> the way I'm reading this purpose portion of the clinical trial is that they're trying to understand exactly how this is working... Which may mean that it actually is working. this may be a good sign


 It seems to me it's probably working, but not as well as they had hoped. They want more information to modify it to improve efficacy. They must be getting pretty decent results though to even bother with that.

----------


## Justinian

> It seems to me it's probably working, but not as well as they had hoped. They want more information to modify it to improve efficacy. They must be getting pretty decent results though to even bother with that.


 It's gotta be either what you said, or in anticipation of the 21st century cures act which allows the use of biomarkers to speed the approval process.

----------


## baldybald

Now the problem is that we do not know what it contains so we can use it on ourselves, like setipiprant

----------


## unbalding

> It's gotta be either what you said, or in anticipation of the 21st century cures act which allows the use of biomarkers to speed the approval process.


 That's a great point, I hadn't thought of that. Hopefully you're right.

----------


## JayM

Guy's we have already been though all of this like 20 pages back.

----------


## lacazette

Hey Jaym, I tried the other day as you asked to contact you on ***, but they don't allow me to access to your profile and send a msg. and still not today dude

----------


## JayM

Hey man no worries. What's your name on ***? I will send you a message  :Smile:

----------


## lacazette

lacazette aswell  :Wink:

----------


## Tenma

> Has anyone seen this trial about SM? https://www.anzctr.org.au/Trial/Regi...aspx?id=368801


 Wow thats great news!

Now they are running 3 trials.

Btw, I don’t know if it was mentioned before but found info from april about samumed expanding their facilities and obtaining a good reduction in taxes:

http://www.sandiegometro.com/2015/04...april-17-2015/

_“…Samumed LLC of San Diego, a biopharmaceutical research and development firm that will create 273 jobs by investing $30.5 million, for which it will receive a $2.1 million tax credit.”_

One thing is for sure, they are investing heavily and have high hopes for this drug.

----------


## lacazette

Good! I still strongly believe in them, when you know Wnt/b catenin act as the key cascade with others, it gives high hopes


Does someone understand the patent's world? and could explain me what does the recent patents applications publications on this 22 october  , and that are concerning us, mean

http://stks.freshpatents.com/Samumed-Llc-nm1.php

_ B- and y -diketones and y -hydroxyketones as wnt/ b -catenin signaling pathway activators

_


-First why on 22 oct they are two applications of the same patent? what does that mean?

-And it's the 'same' patent that we already posted here in 2014, so what are these new ones for, or what are the différences?  (though it's just 'look like' the same patent, so maybe there's could be new things in it as i don't had the time to read it)

----------


## Tomtom21

I feel like samumed may wait to release results from the clinical trial ending this month unitl they have the results from the new smaller trial ending in February.. But the anticipation is slowly starting to kill me lol hopefully they release something regarding the chemical or its effectiveness come the hair congress

----------


## champpy

Does anyone know if their drug is a topical or oral med?

I cant imagine them being such a big sponser of the congress and not presenting anything. Dude, if they even showed a product logo id flip my shyt

----------


## noisette

> Does anyone know if their drug is a topical or oral med?


 https://clinicaltrials.gov/ct2/show/NCT02275351

----------


## JayM

> Does anyone know if their drug is a topical or oral med?
> 
> I cant imagine them being such a big sponser of the congress and not presenting anything. Dude, if they even showed a product logo id flip my shyt


 wow

----------


## Swooping

So how many trials are these guys running now? Did they already finish a clinical trial? Perhaps they will present some preliminary data on the congress on a poster whatsoever.

----------


## Swooping

At the hair congress they will be presenting the results from the 1st phase of the clinical trial..




> Safety and Efficacy of a Topical Treatment (SM04554) for Androgenetic Alopecia (AGA): *Results from a Phase 1 Trial* Yusuf Yazici, MD | USA

----------


## Sogeking

> At the hair congress they will be presenting the results from the 1st phase of the clinical trial..


 Good find. Although Phase 1 is primarily intended for determining safety we might get a glimpse at effectiveness.

----------


## ShookOnes

Would gains be permanent with this anyone guess?

----------


## Tenma

> At the hair congress they will be presenting the results from the 1st phase of the clinical trial..


 Good! I wasnt expecting a presentation from Samumed.

Lets hope Hellouser can record this one

----------


## nameless

> Good find. Although Phase 1 is primarily intended for determining safety we might get a glimpse at effectiveness.


 They might give some hints as to how things are going in their original phase 2 study that is just completing NOW.

----------


## Dobler

> At the hair congress they will be presenting the results from the 1st phase of the clinical trial..


 1st phase of clinical isn't aimed on safety? It won't tell us much about efficiency right?

----------


## JayM

safety and efficacy

----------


## ghostrider

Hi mates

What's so special about this? It works with wnt?

http://www.ncbi.nlm.nih.gov/pubmed/24533507

I read valproic acid has been around for years & its very cheap. 

Can anyone comment on this ?

----------


## JayM

> Hi mates
> 
> What's so special about this? It works with wnt?
> 
> http://www.ncbi.nlm.nih.gov/pubmed/24533507
> 
> I read valproic acid has been around for years & its very cheap. 
> 
> Can anyone comment on this ?


 Swiss uses VPA for WNT activation.

----------


## ghostrider

Hi mate 
Look at this
https://en.m.wikipedia.org/wiki/GSK-3

6-bio is mentioned on thr wkiki site. I read elsewhere its 40.000 stronger than vpa.

Why not use Lithium en zinc Dr cots approach.

----------


## JayM

He also uses licl but only after wounding.

----------


## ShookOnes

anyone know if this would be 100% effective depending on the mechanisms of this product? I'm a diffuser and if I could do another steroid cycle without losing hair I'd be so happy :P

----------


## champpy

Anyone on here have any idea where to get this VPA?

----------


## cratusg

When will we get to know the phase 2 results? Anyone know the predicted time?

----------


## champpy

> When will we get to know the phase 2 results? Anyone know the predicted time?


 Not for sure, but I think they are doing another supplemental phase 2 that will last until FEB, so maybe after then will we hear about the results. Just guessing though

----------


## MasterRay

The samumed presentation at the congress should be great!  

https://www.samumed.com/files/WCHR20...n.20150403.pdf

----------


## MasterRay

The samumed presentation at the congress should be great!  

https://www.samumed.com/files/WCHR20...n.20150403.pdf

----------


## rdawg

At the very least it shows a solid amount of effectiveness here.

Far more interested in the Phase II results which should come early next year, 29 respondents is tiny and at an average age of 44 that doesnt tell you much(as hairloss at that age is most likely finished or going at an incredibly slow rate). 

Show me results on a 25 year old balding person, then you have a bit more of my attention.

Either way there is nothing but positive to take from this, hopefully they are testing at the maximum safe dose and at the very least provide us with an alternative to minox within the next 2-3 years!

----------


## nameless

One thing that I did NOT like is that it said there is systemic absorption so that means it might lead to sexual side effects like gynecomastia and impotence just like these other drugs that get into the body.

----------


## unbalding

Hmm.. Are they trying to steal thunder from Allegan. I hope they provide phase 2 results at the congress. This trial was only 14 days, so it seems to work fast. If this wasn't an aberration this could be huge. 

MasterRay, do you work for Samumed?

----------


## rdawg

> Hmm.. Are they trying to steal thunder from Allegan. I hope they provide phase 2 results at the congress. This trial was only 14 days, so it seems to work fast. I hope this want just an aberration.
> 
> MasterRay, do you work for Samumed?


 Phase II is not complete until February 2016, however they may show early phase II results as it has been about a year, I'm hopeful they do that!

----------


## MasterRay

No Rdawg, i just saw that on their website.

----------


## unbalding

> Phase II is not complete until February 2016, however they may show early phase II results as it has been about a year, I'm hopeful they do that!


 I thought phase 2 completed in October? They are still  doing a IIb, but that is separate.

----------


## Arieux

You are right unbalding, in february ends their another study with biomarkers. That massive phase II ends in october and I really hope that something will be said about it. Conclusions after 14 days on 30 patients don't give us information which I was waiting for.

----------


## rdawg

> I thought phase 2 completed in October? They are still  doing a IIb, but that is separate.


 I believe their initial phase II is complete but they started a 2nd phase II a few months later, so they may very well release the initial results here.

----------


## nameless

> I believe their initial phase II is complete but they started a 2nd phase II a few months later, so they may very well release the initial results here.


 
You might be right. They may release some results from their original phase 2 study at the coming hair loss congress. That study is complete and during their phase 1 study they collected results during the study so they may have done the same thing in their original phase 2 study and if they did then they probably have some information about their original phase 2 study. 

I wish we could get someone to go to the congress and interview Samumed.

Also, since they collected evidence during the phase 1 study that means they likely collected evidence during the original phase 2 and since they are still pursuing their drug deeper into trials that means that the evidence they have so far collected during the original phase 2 study is probably good news.

----------


## champpy

I think a few pages back someone said at the congress they are discussing phase 1 only. But they might let something slip about phase 2

----------


## unbalding

> I think a few pages back someone said at the congress they are discussing phase 1 only. But they might let something slip about phase 2


 It looks like that's the plan, but I'm still hoping.

----------


## lacazette

If someone can confirm me but I think I  saw before that Sarah Millar was involved and supervising one of the locations of the phase2 trial, no?

Follica's team talked years ago about how Wnt activation increase the wounding HF neogenesis, and that safe way were needed, so surely they are interested

If you add the luis Garza discovery (who collaborated a lot with Cotsarelis) about TLR3 activation that is the first signaling pathway involved that could induce the formation of hair follicle on a wound (and that there were already companies developing safe chemical TLR3 activation ) , Follica could have good tools to test soon

 follica was testing years ago on humans their wounding approach with some lithium things, etc

Now imagine, make the wound, then TLR3 activation to make the cells recreate the HF,IFE and SG and then Wnt activation to make this hair follicle become bigger with robust growth (with also growth factors, FGF9, etc)

I wonder what kind of results this will give, maybe enough or maybe still not, but nothing to compared with their lithium and FGF approaches, it's another level, far more powerful
and the safe chemicals applications of Wnt and TLR3 activations are now becoming possible so let's hope Follica is planning new protocols testing soon (with wnt, tlr3, and of course other things based on Cots and millar recent knowledge)
(and maybe the recent Lgr6+ stem cells protocol from the plastic surgeons for creation of a hair follicle in a wound will have an impact)
 a combo : -wounding+TLR3+Lgr6 scaffolded cells transplant+WNT+FGFs- would look like a damn promising protocol

----------


## baldybald

> If someone can confirm me but I think I  saw before that Sarah Millar was involved and supervising one of the locations of the phase2 trial, no?
> 
> Follica's team talked years ago about how Wnt activation increase the wounding HF neogenesis, and that safe way were needed, so surely they are interested
> 
> If you add the luis Garza discovery (who collaborated a lot with Cotsarelis) about TLR3 activation that is the first signaling pathway involved that could induce the formation of hair follicle on a wound (and that there were already companies developing safe chemical TLR3 activation ) , Follica could have good tools to test soon
> 
>  follica was testing years ago on humans their wounding approach with some lithium things, etc
> 
> Now imagine, make the wound, then TLR3 activation to make the cells recreate the HF,IFE and SG and then Wnt activation to make this hair follicle become bigger with robust growth (with also growth factors, FGF9, etc)
> ...


 This is so advanced from the king of hair loss reach Dr Cots. Thank you lacazette for these important news and keep us all updated

----------


## rambo007

lacazette you are great. thanks for giving us so much information.

----------


## SriHanuman

https://www.samumed.com/files/americ...11-03-2015.pdf

And if SM works, they will surely have a similar presentation...

----------


## champpy

I really hope this company succeeds. they seem to be making ground in several areas

----------


## jpar

lacazette do you know Swisstemples ?  he has his own site and is friends with hellouser, the pgd2 protocol worked out great for him!  he's growing hair in the front too!  someone said he got banned from forums is this true???

----------


## Superuser

Seems like they already published their phase 1 results:

https://www.samumed.com/files/WCHR20...n.20150403.pdf

----------


## Sogeking

We won't know much from Phase 1 results. They were only for 14 days.
And we have no idea if NW5s were amongst those that reported hair growth.

----------


## MasterRay

hair congress
http://www.prnewswire.com/news-relea...300181064.html

----------


## champpy

In preclinical in vivo studies, SM04554 has been shown to regenerate new hair follicles and increase hair count in multiple animal models

Regenerate new hair follicles!! Sounds enticing, lets hope thats not just on rats and mice though.

----------


## unbalding

> In preclinical in vivo studies, SM04554 has been shown to regenerate new hair follicles and increase hair count in multiple animal models
> 
> Regenerate new hair follicles!! Sounds enticing, lets hope thats not just on rats and mice though.


 Sounds good, but  how can you REgenerate new hair follicles. You can generate new heir follicles, or you can regenerate old hair follicles. I think they mean the latter. 

I'm a little disappointed because I was hoping they would announce phase II results, but the PR says phase I only. They seem very positive about their results though,  so that's encouraging.

----------


## champpy

It is encouraging. That statement also said they are working cartilage regeneration. that would be awesome too.

 I think replicel is working on a tendon repair formula as well. If both companies are able to regenerate hard to grow cartilage and tendon tissue, then i trust that hair growth is possible as well.

----------


## hiitsjam

Looks like samumed will be announcing clinical data on potential treatment of AGA pretty soon.

http://www.eurekalert.org/pub_releas...-sta111815.php

Exciting stuff and just cant to see the result. Fingers crossed  :Big Grin:

----------


## Dobler

> Looks like samumed will be announcing clinical data on potential treatment of AGA pretty soon.
> 
> http://www.eurekalert.org/pub_releas...-sta111815.php
> 
> Exciting stuff and just cant to see the result. Fingers crossed


  Wow this is exciting! Does anyone have an idea what is the frequency we will need to apply this? ( everyday? Once in a week? Or so...)

----------


## baldybald

I wish if we knew about the ingredients of this

----------


## champpy

I just HOPE the results are superior to minoxidil, and that a higher % of ppl responded to this treatment

----------


## Tenma

Good to hear.

According to hellouser, who was able to speak with the principal investigator, Samumed finished phase two a couple days ago.

Thats why no info will be presented at the congress in Miami about the 300 people trial.

Apparently reults could be disclosed in january.

----------


## xyz123

Promising - this could be our next treatment.

http://www.businesswire.com/news/hom...t-Hair-Density

----------


## jamesst11

LOL to all of this

----------


## xyz123

> LOL to all of this


 Dude - this is the first hair loss drug that is poised to move into a Phase 3 trial in almost 20 years.  Not a bad thing.

----------


## Superuser

> Dude - this is the first hair loss drug that is poised to move into a Phase 3 trial in almost 20 years.  Not a bad thing.


 And how do you now that? They haven't even presented their phase II results yet...

----------


## Tenma

Great news!! Lets hope they confirm findings of preliminary data.

I dont think this is "the cure" but very likely they would give us something better than minox.

btw, want to see some pictures asp  :Cool:

----------


## VegetaDBZ

Someone can help me where to buy this....? I want to test.

Thank you!

----------


## doinmyheadin

> Dude - this is the first hair loss drug that is poised to move into a Phase 3 trial in almost 20 years.  Not a bad thing.


 Yes we need something better then surgery with limited donar hair transplants and useless minox. This is well and truly due. Fingers crossed

----------


## Occulus

> Dude - this is the first hair loss drug that is poised to move into a Phase 3 trial in almost 20 years.  Not a bad thing.


 Agreed - this is very promising.  Also, the study cohorts were all NW 4s or higher, so those with less severe loss could see even better results.  This is very exciting, and seems to be the closest to commercialization of all the current crop of pipeline drugs.

----------


## lifelonglearning

> LOL to all of this


 ...

http://www.prnewswire.com/news-relea...300188222.html

"anotha one"

----------


## trunks

Samumed patent

There are few formulas of diketones in there. One of them is sm04554.

The Androgen Receptor Antagonizes Wnt/β-Catenin Signaling in Epidermal Stem Cells




> *Activation of Wnt/β-catenin signaling in adult mouse epidermis leads to expansion of the stem cell compartment and redirects keratinocytes in the interfollicular epidermis and sebaceous glands (SGs) to differentiate along the hair follicle (HF) lineages. Here we demonstrate that during epidermal development and homeostasis there is reciprocal activation of the androgen receptor (AR) and β-catenin in cells of the HF bulb. AR activation reduced β-catenin-dependent transcription, blocked β-catenin-induced induction of HF growth, and prevented β-catenin-mediated conversion of SGs into HFs. Conversely, AR inhibition enhanced the effects of β-catenin activation, promoting HF proliferation and differentiation, culminating in the formation of benign HF tumors and a complete loss of SG identity. We conclude that AR signaling has a key role in epidermal stem cell fate selection by modulating responses to β-catenin in adult mouse skin*


 Hair follicle stem cell differentiation is inhibited through cross-talk between Wnt/β-catenin and androgen signalling in dermal papilla cells from patients with androgenetic alopecia.



> BACKGROUND:
> Hair follicle (HF) regeneration begins when signals from the mesenchyme-derived dermal papilla cells (DPC) reach multipotent epidermal stem cells in the bulge region. Wnt/β-catenin signalling is known to affect mammalian hair growth positively. In androgenetic alopecia (AGA), androgens cause HF miniaturization through a mechanism that remains unclear. Circulating androgens act on DPC and alter paracrine factors that influence hair epithelial cells.
> OBJECTIVES:
> To elucidate the role of androgens in dermal papilla-induced differentiation of HF stem cells.
> METHODS:
> HF stem cell differentiation was evaluated in a coculture model with DPC or culturing with media conditioned by DPC after activation of androgen and Wnt/β-catenin signalling pathways. To study the molecular cross-talk between the androgen and Wnt signalling pathway in DPC, we analysed the expression and activation of downstream Wnt signalling molecules in the presence of androgens.
> RESULTS:
> In a coculture model with human DPC from patients with AGA and HF stem cells, we observed that androgens abrogate hair differentiation evaluated by hair-specific keratin 6 expression. Wnt signalling activation restored the ability of androgen-treated DPC to induce differentiation. Androgen treatment revealed a significant decrease in the cytoplasmic/total β-catenin protein ratio and upregulation of the activity of glycogen synthase kinase-3β in DPC, indicative of canonical Wnt pathway inhibition.
> CONCLUSIONS:
> These results suggest that androgens deregulate DPC-secreted factors involved in normal HF stem cell differentiation via the inhibition of the canonical Wnt signalling pathway.

----------


## trunks

And Samumed is the only company which tests drugs on >NW4 men.

----------


## xyz123

> And how do you now that? They haven't even presented their phase II results yet...


 If you follow the link: 

"Samumed, LLC, a leader in tissue regeneration, announced today preliminary analysis of efficacy data from its Phase II AGA trial, in which one of the dosage arms, compared to vehicle, showed statistically significant increases for both objective outcome measures: non-vellus hair count (a primary outcome measures) and hair density (a secondary outcome measures), using the pre-specified statistical model."

The Phase II safety and efficacy data so far are very promising and support moving this program into pivotal studies. We are analyzing the efficacy data further and plan to present results of both preclinical and clinical studies at upcoming medical conferences, said Yusuf Yazici, M.D., Chief Medical Officer of Samumed."

----------


## TooMuchHairWontKillYou

Hope statistically significant means visually significant :d

----------


## burtandernie

> Agreed - this is very promising.  Also, the study cohorts were all NW 4s or higher, so those with less severe loss could see even better results.  This is very exciting, and seems to be the closest to commercialization of all the current crop of pipeline drugs.


 If this is closest to coming out how long are we talking? That is really the big issue is the timelines.

----------


## breakbot

> If this is closest to coming out how long are we talking? That is really the big issue is the timelines.


 Two years.

----------


## ShookOnes

> If this is closest to coming out how long are we talking? That is really the big issue is the timelines.


 Phase 3 to commercialization? 5 years

----------


## Follisket

And most importantly, how the hell do we figure out what they're using so we can get some black market production going and actually benefit from this?

----------


## champpy

> Hope statistically significant means visually significant :d


 Imagine if they had said 'dramatically significant', we would all be popping a cork right now

----------


## Occulus

> Two years.


 Two - three years to finish and report stage III results, so we'd know if it works (and how well) by then. 




> Phase 3 to commercialization? 5 years


 Yeah, I'd guess four to five before it was available.  Of course, if the stage III results were good, people would buy it counterfeit as soon as the Chinese started knocking it off.

----------


## xyz123

> Imagine if they had said 'dramatically significant', we would all be popping a cork right now


 Agreed - tough to know the relevance of statistically significant.  A gain in 10 hairs versus a loss of 4 hairs could be statistically significant, though would be cosmetically irrelevant.

I also worry that they indicate that "one of the dosage arms" showed benefit - does this mean that the other dose of SM compared to placebo showed no benefit?  If this is truly going to be an effective therapy - it's hard to believe that a difference of 0.1% (they were comparing 0.15% vs 0.25% vs placebo) would be a game changer.

Tough to know what it all means.  It's also interesting that the treatment durations for these studies is so short.  Phase 1 was 2 weeks and now Phase 2 was 3 months with an additional 45 day follow-up after treatment had stopped.  Maybe they've been concerned about safety and are gradually giving increasing exposures?  If it does regenerate new follicles, maybe 1 year (or indefinite) would provide greater regrowth (maybe that will be the approach in Phase 3?).

Regardless - this is all just worthless speculation...  

That said - it certainly is nice that Samumed appears to be releasing information as it becomes available, in contrast to Allergan and bimatoprost.

Samumed aren't idiots - so if they're going to move forward with Phase 3, they'll presumably have reason to believe that it will provide satisfactory cosmetic regrowth.  No one is going to go to their doctor and pay good money to go from a diffuse Norwood 4 to a mildly less diffuse Norwood 4.

----------


## Joker

Just replying to the above (in the unlikely event any SM reps or other companies ever stumble upon this comment) -- I think A LOT of people would pay A LOT of money to use a topical treatment with no systemic side effects in order to merely maintain their hair (with no regrowth whatsoever). So even modest regrowth on a NW6 translates to excellent maintenance for all other hair loss sufferers.

Also, I agree w/ respect to the "one dosage arm" language. However, it is possible that there is a threshold quantity of the drug that needs to be applied (somewhere between .15 and .25) in order to see efficacy. Of course, this logic goes out the window if only the lowest dose arm saw efficacy (which would be very odd and interesting).

----------


## Tenma

They are  talking about "promising results" and "consistent with preclinical models". 

Restoration of B-catenin signaling leads to regrowth on mice. That means they are growing new hair on humans. 

I think they have something of value, it make no sense to spend millions in long and tedious phase 3 trial just to offer yet another maintenance treatment or something like minox, which only cuts for 1/3 people.

----------


## baldybald

Remember guys a lot of products failed in phase 3 and I hope this is not the one

----------


## TooMuchHairWontKillYou

> Remember guys a lot of products failed in phase 3 and I hope this is not the one


 Can you write briefly what is phase 3? and did hair loss products fail in phase 3 in the past?

----------


## baldybald

> Can you write briefly what is phase 3? and did hair loss products fail in phase 3 in the past?


  I really do not remember the source, but I saw it from a website and one member mentioned that the easiest phase is phase 1 and the most difficult one is phase 3

----------


## Tenma

> I really do not remember the source, but I saw it from a website and one member mentioned that the easiest phase is phase 1 and the most difficult one is phase 3


 The critical moment seems to be the transition from ph. 2 to ph. 3: 38%

phase 3 success rate for small molecules like SM 3: 61%

http://www.biotech-now.org/business-...udy-from-tufts

----------


## xyz123

> Can you write briefly what is phase 3? and did hair loss products fail in phase 3 in the past?


 Wikipedia summarizes nicely:

"Phase III[edit]
This phase is designed to assess the effectiveness of the new intervention and, thereby, its value in clinical practice.[1] The percentage of Phase II trials that proceed to Phase III, as of 2008, is 18%.[6] Phase III studies are randomized controlled multicenter trials on large patient groups (3003,000 or more depending upon the disease/medical condition studied) and are aimed at being the definitive assessment of how effective the drug is, in comparison with current 'gold standard' treatment. Because of their size and comparatively long duration, Phase III trials are the most expensive, time-consuming and difficult trials to design and run, especially in therapies for chronic medical conditions. Phase III trials of chronic conditions or diseases often have a short follow-up period for evaluation, relative to the period of time the intervention might be used in practice.[1] This is sometimes called the "pre-marketing phase" because it actually measures consumer response to the drug."

----------


## rdawg

*The findings are consistent with preclinical in vivo animal models, in which SM04554 has been shown to generate new hair follicles and increase hair count.* 

Looks like we're getting incredibly close to a new product hitting the market.

BIM, SM and Histogen all showing a high amount of efficacy in phase 2+ trials. 

very exciting times! Hopefully SM goes straight to phase III now, very unlikely it fails as they've already proven safety and just need to show widespread efficacy.

On top of that, they seem very happy with this product, already talking about releasing results at the next conference(while BIM was more hush-hush when they didnt quite get amazing results).

----------


## Tenma

I think Bimatoprost is almost done. 

If SM significantly outperforms Minox in trials, the chances of seeing another growth stim will diminish considerably.

I still hope CB comes to the market. A receptor antagonist is always welcome

----------


## allTheGoodNamesAreTaken

> I think Bimatoprost is almost done. 
> 
> If SM significantly outperforms Minox in trials, the chances of seeing another growth stim will diminish considerably.
> 
> I still hope CB comes to the market. A receptor antagonist is always welcome


 Do SM and Bim work on different stages of whatever the chain of processes is that causes follicles to go bad though?

----------


## champpy

If that 21st century cures act passes couldnt they skip phase 3? 
Also, shouldnt that act be getting the yay or nay anyday now?

----------


## BiqqieSmalls

> Imagine if they had said 'dramatically significant', we would all be popping a cork right now


 Sigh. Dramatically significant is not a "statistics" term.

----------


## champpy

If that 21st century cures act passes couldnt they skip phase 3? 
Also, shouldnt that act be getting the yay or nay anyday now?

----------


## doinmyheadin

^^ Yes would love to know whats going on with the act

----------


## deuce

Does this retain hair as well?

----------


## champpy

Duece. We should know more hopefully in jan when phase 2 wraps up. If it retains hair thats a huuuuge plus

----------


## ShookOnes

U guys think it'll work on hairline?

----------


## ghostrider

For maintenance. Forget regrowth. In Greece some users reported positive results with VPA. Which is available already with similar mechanism as sm0

I wonder how would sm0 compare with VPA. Are they equal strength?

----------


## Hairismylife

> For maintenance. Forget regrowth. In Greece some users reported positive results with VPA. Which is available already with similar mechanism as sm0
> 
> I wonder how would sm0 compare with VPA. Are they equal strength?


 Completely non sense.
How would a maintenance drug to usw Nw4 or above for testing if it merely maintains, and you don't even read the article which clearly says that has increase in hair count and density.

----------


## Spaceboy

True, if you read the Samumed site it does say it "creates new follicles." But who knows yet really.

----------


## allTheGoodNamesAreTaken

If recent events have taught us anything it should be that people on boards don't know what the **** they're talking about. Guessing ultimately. Just gotta wait and see.

----------


## ghostrider

For most treatments if you're on time  you increase success rate. In Greece forum they have slight improvement with VPA. Which is working on same pathway.

----------


## champpy

I have a hard time believing it's creating brand new follicles. I think it's more likely it's bringing back to life the dormant follicles and it looks like new growth

----------


## Spaceboy

> I have a hard time believing it's creating brand new follicles. I think it's more likely it's bringing back to life the dormant follicles and it looks like new growth


 This is probably more accurate. Bringing the dormant/resting follicles into anagen.

----------


## ShookOnes

This the transplant killer??

----------


## Tenma

transplant killer or not, the phase II trial enrolled only high norwoods and results were "promising"

Im sure they know for a NW 5 mantaining hair is not the best thing

Its pretty obvious they achieved some regrowth, we dont know how significant though

----------


## finalcut

How long does phase 3 lasts?

----------


## Arieux

I think that it isn't ht killer but rather something which can enable a lot of alopecia sufferers to do HT along with it. We will know soon after the results from phase 2...

We don't know yet anything about phase 3, Hellouser asked them, but there is very little  info from that interview.

We can suspect that the next phase won't be long as it's mainly for regrowth. I think about 1 year, maybe max. 2 years. Let's hope that in next 2-3 years we will have it, Replicel and Histogen...

----------


## ryan82

> I still have like 200-300mg 6-BIO in my freezer from the groupbuy, more than enough for 1 year trial. Im okay to donate some of it if someone is willing to photo document a proper wounding trial + this gsk3 inhibitor. a slick bald scalp would be an interesting test case.  it is this compound: http://www.sigmaaldrich.com/catalog/.../b1686?lang=en
> 
> Keep in mind that this stuff is experimental and stains red, so has to be used at night, or when no one can see you


  Hi Boldy, Do you have results from Bio-6 ?

----------


## Boldy

> Hi Boldy, Do you have results from Bio-6 ?


 Hi ryan, I never gave it a real chance due to the insomnia it gave. that was before the use of st johns wort which is helping me against the Ru sides.  I still have some left if you want it.

----------


## champpy

I just came across some bad news. looks like the 21st century cure is act will not go to senate until sometime next year. original plan was December of this year. this could put SM potential release date a year later than what we hoped for.

looks like there's no way of getting around phase 3

----------


## Spaceboy

Welp that sucks...Thanks for the update.

----------


## champpy

what's one more kick to our crotch right

----------


## ryan82

> Hi ryan, I never gave it a real chance due to the insomnia it gave. that was before the use of st johns wort which is helping me against the Ru sides.  I still have some left if you want it.


 Hello Boldy. Thank you for your reaction. Is sintjanskruid/ sint johns wort helping for sleeping and igf ? i have used it. I get acne from it. 

Also what is your price for selling bio-6 ?

Greetings

----------


## ryan82

> Hi ryan, I never gave it a real chance due to the insomnia it gave. that was before the use of st johns wort which is helping me against the Ru sides.  I still have some left if you want it.


 Hello Boldy. Thank you for your reaction. Is sintjanskruid/ sint johns wort helping for sleeping and igf ? i have used it. I get acne from it. 

Also what is your price for selling bio-6 ? 

Greetings

----------


## Seuxin

Hello,

Even if SM need phase 3, don't worry ! If we can have the formula..we can synthetise it and test it, like setip  :Wink: 

And....6bio was already tested wihtout any results.

----------


## champpy

> Hello,
> 
> Even if SM need phase 3, don't worry ! If we can have the formula..we can synthetise it and test it, like setip 
> 
> And....6bio was already tested wihtout any results.


 This was my thought too, but the more and more i use products bought from black market sources, the more i question if im getting the real deal. 

I just hope some good news comes out in jan once this phase 2 is totally wrapped up. I wont mind the wait as much as long as we are certain we have a good thing on its way

----------


## unbalding

> Hello,
> 
> Even if SM need phase 3, don't worry ! If we can have the formula..we can synthetise it and test it, like setip 
> 
> And....6bio was already tested wihtout any results.


 We may not get the formula until is almost released. They are tight lipped on the details of this drug thus far.

----------


## Tomtom21

And i dont see any phase II resultsbeing posted in January since the supplemental study wont be officially wrapped up until march. I could be wrong (and hope I am becuase im particularly excited about sm) but I dont see it happening. The wait is still on, but at least the light at the end of the tunnel has gotten a bit brighter (i.e hsc, bim, sm, replicel... Even follicum hs the clinical trial ball rolling as per their latest update).

----------


## unbalding

> And i dont see any phase II resultsbeing posted in January since the supplemental study wont be officially wrapped up until march. I could be wrong (and hope I am becuase im particularly excited about sm) but I dont see it happening. The wait is still on, but at least the light at the end of the tunnel has gotten a bit brighter (i.e hsc, bim, sm, replicel... Even follicum hs the clinical trial ball rolling as per their latest update).


 I think they said somewhere that they would announce the results around January.

----------


## BoSox

Sorry if this is old news, but I saw this online about sm04554


In December 2015, the company reported preliminary efficacy results from the trial demonstrating significant increase in non-vellus hair count and hair density in one of the treatment arms as compared with vehicle arm and without treatment-related serious adverse events.

----------


## Seuxin

Anyone already tried 6-bio ? It appear to be a wnt agonist too...If we cannot have SM formula, maybe we could have other wnt agonist no?

----------


## champpy

When they say increase in non vellus hair count, what does that mean? 
Does it mean the hairs that were grown were actual terminal hairs?

----------


## TJT

> When they say increase in non vellus hair count, what does that mean? 
> Does it mean the hairs that were grown were actual terminal hairs?


 Yes, of course.

----------


## BoSox

Shouldn't this be getting more attention with their stated results? Can we get more on this from somebody?

----------


## Spaceboy

We're still waiting on the data from phase II trial if I'm not mistaken. It should be released very shortly or so they said at the conference.

----------


## Dimoxynil

How does it work ? Does its nullify the AR ?

----------


## noisette

Hi 
I would like to post something interested : 
*the meeting of north american hair research society* will take place on 
Friday, March 4, 2016 • 12:00 p.m. - 2:00 p.m.
Washington DC, USA
Registration is required. $25 for Members; $50 for Non-Members

Perhaps, we will have some informations about the phase 2 of SM. 
And the last but not least this : the last phase 2 of SM will finish on March 2016 "*A Study of SM04554 Applied Topically to the Scalp of Male Subjects With Androgenetic Alopecia Analyzed by Biopsy of the Scalp Prior To and Post Dosing*" 

source: 
https://clinicaltrials.gov/ct2/show/...Samumed&rank=3
http://nahrs.org/MeetingsCalendar.aspx

----------


## noisette

And as you can see, Samumed was a coporate supporter of this event on 2015 

http://nahrs.org/MeetingsCalendar/Ar...0/Default.aspx

----------


## TooMuchHairWontKillYou

any news on 21st century cures act??

----------


## champpy

The 21st century act didnt go to the senate in late 2015 as we all had hoped. Its now scheuduled to be heard SOMETIME in 2016...so from what i read theres not a date given as to when we will find out anything. Just when they can fit it in on their own schedule

----------


## xyz123

Samumed has extended follow-up of it's scalp biopsy study to 135 days for secondary endpoints.

https://clinicaltrials.gov/ct2/show/...sm04554&rank=1

Hopefully this means that they've seen good results - and are hoping they get even better with time.

Can't wait to hear the formal results of their Phase 2 study.

----------


## champpy

Good lord, isnt this the 2nd or 3rd time they have extended this phase 2? I beginning to worry that we wont have results on this till 2017

----------


## joel203

When are sammuneds results out for phase 2

----------


## Hemo

> Samumed has extended follow-up of it's scalp biopsy study to 135 days for secondary endpoints.
> 
> https://clinicaltrials.gov/ct2/show/...sm04554&rank=1
> 
> Hopefully this means that they've seen good results - and are hoping they get even better with time.
> 
> Can't wait to hear the formal results of their Phase 2 study.


 Hopefully it's not the opposite and results have been inconclusive.

----------


## xyz123

> Hopefully it's not the opposite and results have been inconclusive.


 I guess we can't know for sure.  But their main Phase 2 trial is completed - and they issued a press release saying the preliminary results are very promising - enough to justify moving forward with a Phase 3 trial.

http://www.businesswire.com/news/hom...t-Hair-Density

So hopefully their extending this second Phase 2 trial (that involved Scalp Biopsies) is reflective of their believing that the results will be sustained (and hopefully get even better) even after therapy is stopped (treatment is for 90 days - and this extension is at 135 days - so 45 days after coming off treatment).

But who knows - as always - just speculation.

----------


## Occulus

> Hopefully this means that they've seen good results - and are hoping they get even better with time.


 When has that ever been the case?  When is it ever "good news" that a study has to be extended?  Never.  

Looks like we can take SM off the list.

----------


## Trackster

Just hope they show good results from their first phase 2 trial. That should hopefully be presented soon.

----------


## TooMuchHairWontKillYou

I see two reasons of expending this trial.

1) They didn't see expected results in this time and gave it more time
2) They saw some results and want to study it more.

----------


## Hubris

> Samumed has extended follow-up of it's scalp biopsy study to 135 days for secondary endpoints.
> 
> https://clinicaltrials.gov/ct2/show/...sm04554&rank=1
> 
> Hopefully this means that they've seen good results - and are hoping they get even better with time.
> 
> Can't wait to hear the formal results of their Phase 2 study.


 I have no medical or scientific background. Could someone please explain what the above implies? Does this mean that they are conducting another phase 2, or that they are extending the length of time that they are investigating the results of the phase 2? Alternatively, something else? Thanks.

----------


## dus

> I have no medical or scientific background. Could someone please explain what the above implies? Does this mean that they are conducting another phase 2, or that they are extending the length of time that they are investigating the results of the phase 2? Alternatively, something else? Thanks.


 Guess: they are extending the current trial by 45 days, so probably shit is still happening that they can monitor. If it was a dud, they wouldn't extend it.

----------


## TooMuchHairWontKillYou

> I have no medical or scientific background. Could someone please explain what the above implies? Does this mean that they are conducting another phase 2, or that they are extending the length of time that they are investigating the results of the phase 2? Alternatively, something else? Thanks.


 They have finished first phase 2 (October 2014 - November 2015)

and now they are expanding their second phase 2 (biopsy)

----------


## BoSox

This would be amazing if it could bridge me(us) to Replicel. Praying for good results.

----------


## Hemo

> This would be amazing if it could bridge me(us) to Replicel. Praying for good results.


 This probably won't be available for another 3 years if it goes into production - they still have to plan and run their phase III trial and handle everything that goes into production.  If we're lucky, Replicel will be available in Mexico sooner than this.
However, I also have high hopes for this - can't wait to see the initial phase II results.

----------


## Trouse5858

If the 21st century Cure Act were to nullify the need for a phase III what would be an optimist timeline for this??

----------


## doinmyheadin

> This probably won't be available for another 3 years if it goes into production - they still have to plan and run their phase III trial and handle everything that goes into production.  If we're lucky, Replicel will be available in Mexico sooner than this.
> However, I also have high hopes for this - can't wait to see the initial phase II results.


  I think your refering to Histogen regarding Mexico release.  Replicel is now experiencing more delays in the German trial and may not start to the end of this year! No news on whether Shiseido will begin as yet. Replicel are yet to post any cosmetic results. I peraonally dont have much faith in them. Hopefully im wrong, fingers crossed for Histogen with no more delays.

----------


## Occulus

> If the 21st century Cure Act were to nullify the need for a phase III what would be an optimist timeline for this??


 You - and many others on this board - fundamentally don't understand what that bill's about.  It doesn't get rid of phase III trials, it allows drugs that haven't completed phase III trials to be given to patients in DIRE NEED.  Cosmetic applications will not be considered "dire need" situations.  That act will have absolutely NO IMPACT on drugs trailing for hair loss.  None.   It will apply to those conditions that are TERMINAL ONLY.

----------


## Hemo

> If the 21st century Cure Act were to nullify the need for a phase III what would be an optimist timeline for this??


 I guess that depends when the Cure Act goes to a vote - we're in Jan, and it might not get approved until December for all we know.  Even so, I think people are getting really optimistic about that eliminating phase III for all AGA treatments.  My understanding is that its focus is to expedite approval of cell based treatments (eg stem cell treatments), which would only affect a few new procedures.  I'm not sure this will qualify, but happy to hear other points of view.

----------


## ShookOnes

> You - and many others on this board - fundamentally don't understand what that bill's about.  It doesn't get rid of phase III trials, it allows drugs that haven't completed phase III trials to be given to patients in DIRE NEED.  Cosmetic applications will not be considered "dire need" situations.  That act will have absolutely NO IMPACT on drugs trailing for hair loss.  None.   It will apply to those conditions that are TERMINAL ONLY.


 
You couldn't be more wrong lol. Why don't you do actual research on the type of therapies it involves? Hint: starts with cell.

----------


## champpy

I believe somewhere it was reported that samumed would be releasing more info at the next conference they attended. I tried to google search to see if they were scheduled at any upcoming events but couldnt find any. Anyway, hopefully soon they will give us a tidbit on further developments

----------


## xyz123

> When has that ever been the case?  When is it ever "good news" that a study has to be extended?  Never.  
> 
> Looks like we can take SM off the list.


 Wow...  Great statement - studies in medicine get extended ALL OF THE TIME when a positive result is seen - they want to observe 1) Is the result sustained? 2) Do the results get better over time?  When do studies not get extended? - when the initial results are an abject failure.

We already know SM works - they've said in a press release they've seen enough to move on to Phase 3 trials.  The question is how well.

They've just gotten WAY MORE ambitious with their endpoints in this study - when the trial was initially posted there were a couple of primary and secondary endpoints.  Now there are LONG lists for each.  If a drug is failing, companies don't suddenly invest more money into a failing drug - and they don't suddenly expand the number of endpoints to be examined to highlight how bad the drug is.  Samumed has drugs in development in 10 other areas of medicine - if the drug was failing, they wouldn't be wasting more money in this area.  They would be quietly moving on.

SM works - and - although we can't be certain - I think it's hugely positive that they've added an endpoint 45 days after treatment has stopped.  As another poster said - this HIGHLY suggests that they've seen something from their original Phase 2 study to make them believe that the result is sustained or even gets better.

I can't wait for them to present their Phase 2 results.

----------


## Occulus

> Wow...  Great statement - studies in medicine get extended ALL OF THE TIME when a positive result is seen - they want to observe 1) Is the result sustained? 2) Do the results get better over time?  When do studies not get extended? - when the initial results are an abject failure.
> 
> We already know SM works - they've said in a press release they've seen enough to move on to Phase 3 trials.  The question is how well.
> 
> They've just gotten WAY MORE ambitious with their endpoints in this study - when the trial was initially posted there were a couple of primary and secondary endpoints.  Now there are LONG lists for each.  If a drug is failing, companies don't suddenly invest more money into a failing drug - and they don't suddenly expand the number of endpoints to be examined to highlight how bad the drug is.  Samumed has drugs in development in 10 other areas of medicine - if the drug was failing, they wouldn't be wasting more money in this area.  They would be quietly moving on.
> 
> SM works - and - although we can't be certain - I think it's hugely positive that they've added an endpoint 45 days after treatment has stopped.  As another poster said - this HIGHLY suggests that they've seen something from their original Phase 2 study to make them believe that the result is sustained or even gets better.
> 
> I can't wait for them to present their Phase 2 results.


 Great - give me some examples of a product that made it to market after the Phase IIs were extended.  I can give you some that didn't, particularly hair growth protocols, to wit: bimotoprost, dutasteride, etc.

----------


## BoSox

> Wow...  Great statement - studies in medicine get extended ALL OF THE TIME when a positive result is seen - they want to observe 1) Is the result sustained? 2) Do the results get better over time?  When do studies not get extended? - when the initial results are an abject failure.
> 
> We already know SM works - they've said in a press release they've seen enough to move on to Phase 3 trials.  The question is how well.
> 
> They've just gotten WAY MORE ambitious with their endpoints in this study - when the trial was initially posted there were a couple of primary and secondary endpoints.  Now there are LONG lists for each.  If a drug is failing, companies don't suddenly invest more money into a failing drug - and they don't suddenly expand the number of endpoints to be examined to highlight how bad the drug is.  Samumed has drugs in development in 10 other areas of medicine - if the drug was failing, they wouldn't be wasting more money in this area.  They would be quietly moving on.
> 
> SM works - and - although we can't be certain - I think it's hugely positive that they've added an endpoint 45 days after treatment has stopped.  As another poster said - this HIGHLY suggests that they've seen something from their original Phase 2 study to make them believe that the result is sustained or even gets better.
> 
> I can't wait for them to present their Phase 2 results.


 
Thanks for clarifying that up! When exactly will they presenting those results?

----------


## bigentries

> If a drug is failing, companies don't suddenly invest more money into a failing drug - and they don't suddenly expand the number of endpoints to be examined to highlight how bad the drug is.  Samumed has drugs in development in 10 other areas of medicine - if the drug was failing, they wouldn't be wasting more money in this area.  They would be quietly moving on.


 This has happened before. Aderans expanded their phase two studies drastically with all the JiGami timelines that went absolutely nowhere

----------


## dus

> This has happened before. Aderans expanded their phase two studies drastically with all the JiGami timelines that went absolutely nowhere


 Treatment methods aren't really comparable. This is just a drug.

----------


## Occulus

> Treatment methods aren't really comparable. This is just a drug.


 Tell yourself whatever you need to to make this really bad news sound better.

----------


## nameless

> You - and many others on this board - fundamentally don't understand what that bill's about.  It doesn't get rid of phase III trials, it allows drugs that haven't completed phase III trials to be given to patients in DIRE NEED.  Cosmetic applications will not be considered "dire need" situations.  That act will have absolutely NO IMPACT on drugs trailing for hair loss.  None.   It will apply to those conditions that are TERMINAL ONLY.


 You're dead wrong. The cures act passed by the house would allow virtually ALL drugs to use biomarkers in place of a phase 3 study. ALL.

----------


## nameless

> Tell yourself whatever you need to to make this really bad news sound better.


 Dude, this may be bad news but none of us knows yet. You're guessing.

----------


## dus

> Tell yourself whatever you need to to make this really bad news sound better.


 Tell yourself whatever you need to to make this non-news sound bad.

----------


## Tenma

They are extending their complementary phase II. The big one finished on november and Samumed principal investigator said the results where very promising.

Yazici also said the company  will present results on upcoming medical conferences, so we'll have to wait a little more to know how effective this stuff really is

Some people are just too negative without any good reason

----------


## 20legend

After going through the trial changes made on Jan 12 for SM, I think the important part is they want to study the changes taking place 45 days after stopping the treatment, key being stopping treatment. 

My guess would be they saw something during the initial 90 days and now want to see if those changes last after the application is stopped or not. Something similar to Minox where the effect diminishes after you stop using it. 
Also note they will be monitoring B-catenin levels Ki expressions after 45 days. So if the effect diminishes maybe they will determine it from those levels. 

Again all this is assumptions. We have had severe bad luck in the past.

----------


## nameless

I just figured something out guys.

The US Senate originally intended to do the 21st Century Cures Act in January 2016 and Samumed originally intended to conclude its' supplemental phase 2 study in January 2016.

The Senate delayed the 21st Century Cures until Spring 2016 and Samumed also extended their supplemental phase 2 study until Spring 2016. 

Interesting. I think this looks like a VERY positive sign. It looks like Samumed decided to extend their supplemental phase 2 study so they could gather more biological information (since the 21st Century Cures has been delayed anyway) in the hope that they can take advantage of the Acts provision to allow drug companies to use biologic data in lieu of a phase 3 study. It looks like Samumed recognized that the cures Act would be delayed a few months so they decided to use those few months to gather more biological information. If I'm right that means Samumed is hoping to skip phase 3 and it also means that they think their drug is better than what is currently on the market. 

It looks very conspicuous that Samumed's original completion date for the supplemental phase 2 happened to coincide with when the Cures Act was originally intended to pass and Samumed's extension of their supplemental phase 2 study happens to also coincide the intended time frame when the Cures Act will pass.

----------


## doinmyheadin

> I just figured something out guys.
> 
> The US Senate originally intended to do the 21st Century Cures Act in January 2016 and Samumed originally intended to conclude its' supplemental phase 2 study in January 2016.
> 
> The Senate delayed the 21st Century Cures until Spring 2016 and Samumed also extended their supplemental phase 2 study until Spring 2016. 
> 
> Interesting. I think this looks like a VERY positive sign. It looks like Samumed decided to extend their supplemental phase 2 study so they could gather more biological information (since the 21st Century Cures has been delayed anyway) in the hope that they can take advantage of the Acts provision to allow drug companies to use biologic data in lieu of a phase 3 study. It looks like Samumed recognized that the cures Act would be delayed a few months so they decided to use those few months to gather more biological information. If I'm right that means Samumed is hoping to skip phase 3 and it also means that they think their drug is better than what is currently on the market. 
> 
> It looks very conspicuous that Samumed's original completion date for the supplemental phase 2 happened to coincide with when the Cures Act was originally intended to pass and Samumed's extension of their supplemental phase 2 study happens to also coincide the intended time frame when the Cures Act will pass.


 Thats very cryptic..

----------


## Hemo

I don't think the delay is necessarily bad, but your theory doesn't make much sense.  If the Cures act was supposed to be voted on in Jan, why would they want to end their trial at the same time? It would make more sense to end their trial *prior to* the vote so they could have data/analyses/evidence on hand to submit as soon as possible.

I also think you mean suspicious and not conspicuous.

----------


## nameless

> I don't think the delay is necessarily bad, but your theory doesn't make much sense.  If the Cures act was supposed to be voted on in Jan, why would they want to end their trial at the same time? It would make more sense to end their trial *prior to* the vote so they could have data/analyses/evidence on hand to submit as soon as possible.
> 
> I also think you mean suspicious and not conspicuous.


 
1. I meant conspicuous. Conspicuous means something is clear visible...stands out

2. What do you mean my theory doesn't make sense? Why would it make more sense to end their trial prior to the vote? How can you be sure of that? We don't know all of the ins and outs and fine details of gathering clinical trial data and submissions to the FDA.  I disagree with you. I think it's conspicuous (clear) that Samumed is making the development of SM04554 mirror the track of the "Cures Act". The small and large details of how far before or after passage of the Cures Act would be the optimum date to have SM04554 complete the extended phase 2 trials is something none of us would know. We don't know all of the details of what Samumed would have to do in order to best take advantage of the passage of the Cures Act insofar as their product SM04554 goes.

----------


## nameless

Nope. Not cryptic at all. It's a positive sign. 




> Thats very cryptic..


 


> I just figured something out guys.
> 
> The US Senate originally intended to do the 21st Century Cures Act in January 2016 and Samumed originally intended to conclude its' supplemental phase 2 study in January 2016.
> 
> The Senate delayed the 21st Century Cures until Spring 2016 and Samumed also extended their supplemental phase 2 study until Spring 2016. 
> 
> Interesting. I think this looks like a VERY positive sign. It looks like Samumed decided to extend their supplemental phase 2 study so they could gather more biological information (since the 21st Century Cures has been delayed anyway) in the hope that they can take advantage of the Acts provision to allow drug companies to use biologic data in lieu of a phase 3 study. It looks like Samumed recognized that the cures Act would be delayed a few months so they decided to use those few months to gather more biological information. If I'm right that means Samumed is hoping to skip phase 3 and it also means that they think their drug is better than what is currently on the market. 
> 
> It looks very conspicuous that Samumed's original completion date for the supplemental phase 2 happened to coincide with when the Cures Act was originally intended to pass and Samumed's extension of their supplemental phase 2 study happens to also coincide the intended time frame when the Cures Act will pass.

----------


## Tomtom21

I think everyone needs to shut up about the cures act and skipping phase III. I think we can say with near certainty samumed will need to conduct a phase III. In light of that I think the extension is neither good nor bad. I believe it is samumed covering their asses due to the fact that messing with wnt pathways can potentiate cancer development and risks. Thus by taking biopsys and checking biomarkers they may better establish safety of their product. Like other products mentioned on *** regarding curis.. Product 100% worked for hairgrowth but also caused/increased risk of cancer. I truly believe samumeds gonna be big how big im not sure but for them to even come out in their last media release claiming hair follicle generation speaks for itself. I think again this is more about ensuring the product can get to market as fast as possible without hitting red tape issues later on about carcinogenicity issues

----------


## nameless

> I don't think the delay is necessarily bad, but your theory doesn't make much sense.  If the Cures act was supposed to be voted on in Jan, why would they want to end their trial at the same time? It would make more sense to end their trial *prior to* the vote so they could have data/analyses/evidence on hand to submit as soon as possible.
> 
> I also think you mean suspicious and not conspicuous.


 Also, I think that after these congressional acts are completed they go to the president for signature and then they become law after some small amount of time like 30 days or 90 days or something like that. This is what I mean by we do not know all of the ins and outs and fine details for when is the optimum time for Samumed to complete their supplemental trial; the only thing we can see for certain is that Samumed's track for completing their supplemental phase 2 trial is running parallel to the completion of the Cures Act even when the timeline of the Cure's Act changes.

----------


## nameless

> I think everyone needs to shut up about the cures act and skipping phase III. I think we can say with near certainty samumed will need to conduct a phase III. In light of that I think the extension is neither good nor bad. I believe it is samumed covering their asses due to the fact that messing with wnt pathways can potentiate cancer development and risks. Thus by taking biopsys and checking biomarkers they may better establish safety of their product. Like other products mentioned on *** regarding curis.. Product 100% worked for hairgrowth but also caused/increased risk of cancer. I truly believe samumeds gonna be big how big im not sure but for them to even come out in their last media release claiming hair follicle generation speaks for itself. I think again this is more about ensuring the product can get to market as fast as possible without hitting red tape issues later on about carcinogenicity issues


 I think you need to shut up with telling other people to shut up. I also think it's OBVIOUS that Samumed is intentionally mirroring the Cures Act. It's obvious because they initially planned to complete their supplemental phase 2 about the same time the Cures Act would pass. Then the government changed the date the Cures Act would pass and Samumed changed the date their phase 2 would complete and they again set the completion date to mirror the Cures Act completion.

It's clear that Samumed intends to try to activate the provision in the cures act that allows them to skip the phase 3. If the cures act passes with the provision that would allow drug companies to skip the phase 3 then Samumed will skip the phase 3. That is their obvious intention.

----------


## Tomtom21

@nameless... same team bud. I like you just want to see something come to market for improvement this hair loss condition sucks and can be an emotional/psychologic terror. For one, I said to chill with Cures Act because this beautiful country's legislation making process could allow the senate to completely butt rape the intended Cures Act so that it looks nothing like its original provision, or they can attach all junk provisions to the ends of it so that it fails to be passed through, or just completely take action on it to get it approved.  I think caution must be used when discussing the implementation of legislation that has yet to pass senate. Also, while Samumed has changed its time line in what may seem like in accordance with the changes in Cures Act timeline, it is hard to say they intend to skip phase III. Most companies operate on a pray for the best (cures act passes and skip phase III) , but expect the worst (Cures Act is botched and Phase III is required). Either way we both have our own opinions on the matter all I am saying is I believe that pending an improved safety profile data from the biomarkers, this could be good news in expediting approval either way with or without cures act because we wont have to worry about FDA claiming its carcinogenic. Same team brother hopefully we hear something soon, Id love to know if anybody has heard anything regarding when Samumed might make their next appearance and announce some data.

----------


## nameless

> @nameless... same team bud. I like you just want to see something come to market for improvement this hair loss condition sucks and can be an emotional/psychologic terror. For one, I said to chill with Cures Act because this beautiful country's legislation making process could allow the senate to completely butt rape the intended Cures Act so that it looks nothing like its original provision, or they can attach all junk provisions to the ends of it so that it fails to be passed through, or just completely take action on it to get it approved.  I think caution must be used when discussing the implementation of legislation that has yet to pass senate. Also, while Samumed has changed its time line in what may seem like in accordance with the changes in Cures Act timeline, it is hard to say they intend to skip phase III. Most companies operate on a pray for the best (cures act passes and skip phase III) , but expect the worst (Cures Act is botched and Phase III is required). Either way we both have our own opinions on the matter all I am saying is I believe that pending an improved safety profile data from the biomarkers, this could be good news in expediting approval either way with or without cures act because we wont have to worry about FDA claiming its carcinogenic. Same team brother hopefully we hear something soon, Id love to know if anybody has heard anything regarding when Samumed might make their next appearance and announce some data.


 Sorry for getting after you. I took it a little personal the way you said, "Shut up" but now I know you didn't really mean it the way it sounded. I see now that you are a much more reasonable person. That having been said, we are going to have to disagree because while I agree with you that the act could change radically in respect to the provision I'm referring to about skipping phase 3, I do not think it's going to. My reasons for that are (1) the USA has to compete with other countries and the USA knows that Japan has passed legislation that allows for reducing the time for clinical trials, including eliminating phase 3 in some cases and (2) I think pharma (including Samumed) has people in the know who have a good idea how the senators are planning to vote on that specific provision and I think the way Samumed mirrored Congress's original anticipated passage date (for the Cures Act) and then later when Congress changed that date Samumed changed their date to again mirror Congress's NEW anticipated date of passage looks too designed to be coincidental. I definitely believe that Samumed changed the completion date of their supplemental phase 2 to coincide with when Congress will pass the Cures Act. I think that when Congress extended the date to approve the Cures Act Samumed decided to extend the date of their supplemental phase 2 because they figured they might as well keep gathering more biological information since Congress delayed the Cures Act passage anyway.

----------


## Hemo

I emailed them yesterday to see if they had a target conference/timing for when initial phase II results would be released - doubt I'll get an answer, but maybe they'll put something out if a lot of people email?

They seem to have a pretty low profile - not much of an online presence other than a facebook with no posts and a website, which is pretty light on details.

----------


## nameless

> I emailed them yesterday to see if they had a target conference/timing for when initial phase II results would be released - doubt I'll get an answer, but maybe they'll put something out if a lot of people email?
> 
> They seem to have a pretty low profile - not much of an online presence other than a facebook with no posts and a website, which is pretty light on details.


 I'll email them today or tomorrow.

----------


## noisette

> Hi 
> I would like to post something interested : 
> *the meeting of north american hair research society* will take place on 
> Friday, March 4, 2016 • 12:00 p.m. - 2:00 p.m.
> Washington DC, USA
> Registration is required. $25 for Members; $50 for Non-Members
> 
> Perhaps, we will have some informations about the phase 2 of SM. 
> And the last but not least this : the last phase 2 of SM will finish on March 2016 "*A Study of SM04554 Applied Topically to the Scalp of Male Subjects With Androgenetic Alopecia Analyzed by Biopsy of the Scalp Prior To and Post Dosing*" 
> ...


 I think it would be an eventual meeting for samuned ! What do you think dude ?

----------


## noisette

And as you can see, Samumed was a coporate supporter of this event on 2015 

http://nahrs.org/MeetingsCalendar/Ar...0/Default.aspx

----------


## iaskdumbquestions

I live in DC, but as my username suggests, I'd probably ask dumb questions.

----------


## nameless

> I think it would be an eventual meeting for samuned ! What do you think dude ?


 I don't know for sure yet but but since they were there last year it does seem possible. I hope we can get someone to go. 

One thing though is that it looks to me like their supplemental phase 2 will end in April not March.

----------


## Tomtom21

@nameless my dude like you Im dying from the suspense of awaiting sm trial results. Im doing my best to keep things in perspective because Id rather have expectations surpassed rather than let down. However, they even came out in that last press release from december making big claims (but again could just be a media blitz for attention/warrant interest in the company). Anyways, I did some digging into that conference they allegedly will be at in march. They will be there and yazici & co will have an eposter presentation. Unfortunately, from what their abstract states it will be basically everything they presented at WHC in november (the phase I study). We need someone to attend so lets get the word out that whoevers local needs to try and milk out some answers for the greater good. 
Btw here is the link to their abstract for the upcoming congress:
https://www.aad.org/eposters/view/Abstract.aspx?id=3299

----------


## dm90

The results will more than likely not be posted until after the extended trials are complete in April.  Remember they still have to collect and analyze all of the data.  I really doubt they are going to rush out the results while the trial is still ongoing.  Hellouser already interviewed them and they didn't have much to say.  However the interest has been made known to them so I really think that "milking" them would be a waste of time.  These guys are drug developers and they will out out the results when they're ready.  Just be patient, take a break from the forums.  Personally I think that the extended trials are just to monitor the potential for cancer.  They aren't going to rush out a drug that could potentially tank their entire company.  Personally I am very excited about the potential of this drug, it would be a growth stimulant that we actually know how it works, unlike minoxidil.  The science is very sound too.

----------


## dm90

In addition, there was already a press release saying they were successful in modulating the WNT pathway for their osteoarthritis trial, so that's good news, they can actually do what they theorized, for osteoarthritis at least

----------


## kim889

I typed "Wnt pathway" on Google and all this stuff is related to cancer. It's scary to know SM04554 is dealing with this, how can we know if this can provok cancer after 5/10 years of using this?

----------


## Seuxin

kim889, stop being silly....Trust scientist and doctors....it's their job...If a drug need a lot of time to be approval it's not for nothing...

----------


## iaskdumbquestions

I would take cancer in 10 years in exchange for hair now. I would do almost anything to be able to enjoy my 20s.

----------


## Follisket

Hair loss _is_ cancer.

----------


## stratowich

> I would take cancer in 10 years in exchange for hair now. I would do almost anything to be able to enjoy my 20s.


 Choose your words more wisely mate. Pretty much every person having cancer would rather be bald than go through chemotherapy, radiation treatment, surgery or the fears of actually dying from the illness (which many people do in the long haul)

You don't need hair to enjoy your 20s!

----------


## stayhopeful

Guys, I just glossed over some of the comments here and look at what you are saying from a different perspective. 

Balding is one of the worst things in the world.  Don't compare it to cancer.  And don't say you would trade hair in 20s for cancer 10 years later, that is one of the dumbest things i've ever heard.  It's a free world you can think that if you want, but i'll tell you right now you need to be a little smarter than that.  I am inyoung too so I know what the feeling is.  Work on some other stuff , this year a de facto cure will be found; there is way too much stuff out there it's about to explode.  There will be a way to maintain hair with no side effects and hopefully improved surgical methods like pilofocus and anything else with regeneration

----------


## Hemo

How about we let the professionals decide if this might cause cancer?  The only way to be sure if it does so 5-10 years down the line is to wait that long, and I don't think anyone sees that as realistic.

If you're worried about the risks if/when this comes to market, then don't take it. I highly doubt a company whose treatments revolve around the wnt pathway are unaware of the potential risks (and I doubt they want to ruin their careers).  I'm not someone who blindly trusts but it seems to be common knowledge that manipulating the wnt pathway can cause cancer; I don't think they'd be doing what they're doing without knowing ways to limit/eliminate that risk.

----------


## dm90

> I typed "Wnt pathway" on Google and all this stuff is related to cancer. It's scary to know SM04554 is dealing with this, how can we know if this can provok cancer after 5/10 years of using this?


 They can look for Histological changes from the biopsies,  there are pretty obvious signs on a histological level if a compound can lead to cancer.  Dont start worrying about potential cancer for a drug that hasnt even been approved yet, If it gets to that point chances are its safe.  I was merely saying thats probably what the extended biopsy trials are for.

----------


## Seuxin

I wondered if anyone already tried the wnt agonist selled on TheKaneShop nammed 6-bio ? It's cheap....but i don't know the amount to use ! Anyone have informations about this ?

----------


## iaskdumbquestions

> Hi 
> I would like to post something interested : 
> *the meeting of north american hair research society* will take place on 
> Friday, March 4, 2016 • 12:00 p.m. - 2:00 p.m.
> Washington DC, USA
> Registration is required. $25 for Members; $50 for Non-Members
> 
> Perhaps, we will have some informations about the phase 2 of SM. 
> And the last but not least this : the last phase 2 of SM will finish on March 2016 "*A Study of SM04554 Applied Topically to the Scalp of Male Subjects With Androgenetic Alopecia Analyzed by Biopsy of the Scalp Prior To and Post Dosing*" 
> ...


 
I sent the coordinator an email, and she said the speakers are George Cotsarelis and Desmond Tobin. Unfortunately Samumed will not be there  :Frown:

----------


## Tomtom21

I sent the coordinator an email, and she said the speakers are George Cotsarelis and Desmond Tobin. Unfortunately Samumed will not be there 


Comb through the last link I posted... They will be presenting an electronic poster session on March 5, from 12:15-12:20 or some thing like that on their phase 1 study.... Just gotta be patient and wait for phase II results to be published

----------


## TooMuchHairWontKillYou

Saw it today. Posted 2/1/2016
http://www.biospace.com/jobs/job-lis...-access-353809

It says that Samumed is looking for director for sales _"RESPONSIBILITIES: Develop market access strategy for initial drug launch and build associated team"_

Maybe it's nothing special but still better than nothing :d

----------


## Tomtom21

Nice find... If you read the position it placed emphasis on the molecule for OA. Hopefully that doesnt mean they are going to prioritize the launch of that molecule before sm04554 because that molecule is just recruiting for phase 2 study now. Well just gave to wait and see what the coming months bring us.

----------


## Hemo

> Saw it today. Posted 2/1/2016
> http://www.biospace.com/jobs/job-lis...-access-353809
> 
> It says that Samumed is looking for director for sales _"RESPONSIBILITIES: Develop market access strategy for initial drug launch and build associated team"_
> 
> Maybe it's nothing special but still better than nothing :d


 The first bullet specifies "Set strategic priorities from a market access standpoint pertaining to Samumeds initial launch of a novel *OA* drug" - OA meaning Osteoarthritis.  I'd be pretty excited if it said AA but it seems this person wouldn't be focused on that, at least not yet.

----------


## TooMuchHairWontKillYou

> The first bullet specifies "Set strategic priorities from a market access standpoint pertaining to Samumeds initial launch of a novel *OA* drug" - OA meaning Osteoarthritis.  I'd be pretty excited if it said AA but it seems this person wouldn't be focused on that, at least not yet.


 Oh Shi t :|

----------


## rdawg

> The first bullet specifies "Set strategic priorities from a market access standpoint pertaining to Samumeds initial launch of a novel *OA* drug" - OA meaning Osteoarthritis.  I'd be pretty excited if it said AA but it seems this person wouldn't be focused on that, at least not yet.


 If they do launch this hairloss drug, it wont be for another couple years, doubtful they'd hire someone for that right now, it's too premature.

----------


## paleocapa89

What is interesting, is that if I am interpreting this correctly they only started enrollment of patients to their Phase II clinical trail of their OA drug in 2015 November 6. And they are already hiring a sales director?

https://www.samumed.com/files/begins...11-06-2015.PDF

----------


## Hemo

I'm not gonna harp on about the phase IIb delay anymore, but I just re-read their initial study's timeline which "involved a 90‐day once‐a‐day treatment period and a 45‐day post‐treatment follow up." (this was taken from their website).  Extending their phase IIb by 45 days simply allows them to take the same 45 day post-treatment measure as the initial phase II, at least in my opinion (for a total 135 day trial, same as the first).

----------


## 20legend

On clinical trails, the SM phase 2b trials isn't recruitment any more. Guess they got the required people. 
It say it should finish by April so hopefully sometime next month we got a positive update from them. 

In the meantime all we can do if find out about their molecule. Coz I think many ppl will be willing to give this a try.

----------


## TooMuchHairWontKillYou

Interesting article http://www.readcube.com/articles/10.1038%2Fnbt0216-120

But can't read the second page. If someone has access to it please copy it here  :Smile:

----------


## baldybald

We need to pay to see it though

----------


## allTheGoodNamesAreTaken

"We have good evidence that bimatoprost [Latisse] stimulates hair growth, but skin absorption with our formulation was less than 1% so most of it was wasted, he says. Allergan has since developed a new formulation with increased scalp penetrance, which will enter phase 1 safety testing in February."   

I didn't know about this.

----------


## stratowich

> Interesting article http://www.readcube.com/articles/10.1038%2Fnbt0216-120
> 
> But can't read the second page. If someone has access to it please copy it here


 Nice to see a well written article on AGA in a high profile journal like Nature Biotechnology.

There isn't actually too much information on the second page (the article only consists of 2 pages). However, there is mentioning of another Milan-based company developing a topical DHT antagonist which sounds to have potentials:
_"The oral DHT inhibitor Propecia, also used in a higher dose for treating enlarged prostates, slows hair loss but has potential side effects that include impotence and dizziness. Moreover, the drug is approved only for men, since exposures during pregnancy can harm the fetus.
Instead, Cassiopea of Milan, Italy is developing a topical DHT antagonist called Breezula for alopecia treatment. According to the company’s chief executive officer, Diana Harbort, the drug breaks down into harmless byproducts on entering circulation. If approved, Breezula would be the first anti-DHT compound available for use in both men and women. Currently a boutique firm specializing in dermatology, Cassiopeia was spun off by its parent company, Cosmo Pharmaceuticals, in January 2015."_

----------


## Hubris

> Interesting article http://www.readcube.com/articles/10.1038%2Fnbt0216-120
> 
> But can't read the second page. If someone has access to it please copy it here


 Very interesting article. What I could read of it anyway.

----------


## paleocapa89

> Nice to see a well written article on AGA in a high profile journal like Nature Biotechnology.
> 
> There isn't actually too much information on the second page (the article only consists of 2 pages). However, there is mentioning of another Milan-based company developing a topical DHT antagonist which sounds to have potentials:"[/I]


 That's CB-03-01

----------


## nameless

> Interesting article http://www.readcube.com/articles/10.1038%2Fnbt0216-120
> 
> But can't read the second page. If someone has access to it please copy it here


 Wilma Bergfield says the results seem encouraging. That sounds kind of tame.

----------


## Hemo

> Wilma Bergfield says the results seem encouraging. That sounds kind of tame.


 The first paragraph also says they plan to move onto phase 3.  You think they'd move on with "tame" results?

----------


## iaskdumbquestions

http://www.haarproblemen.nl/research...ten-voor-2015/

Saw this posted on the other forum...

----------


## 20legend

What is the link about ? Care to elaborate? The translate option doesn't help much either

----------


## nameless

> The first paragraph also says they plan to move onto phase 3.  You think they'd move on with "tame" results?


 I agree that if they move to phase 3 that's a good sign. 

But a lot of phase 2 companies say they're going to move to phase 3 but then it never happens. We have to wait to see if they actually do it.

----------


## addict

The link was broken - should've been http://www.haarproblemen.nl/research...ten-voor-2015/ which is meant to show a before/after for SM04554. It's bogus though - the picture is of a H&W HT https://hassonandwong.com/hair-trans.../patient-1890/

----------


## rdawg

> I agree that if they move to phase 3 that's a good sign. 
> 
> But a lot of phase 2 companies say they're going to move to phase 3 but then it never happens. We have to wait to see if they actually do it.


 There hasn't been a single company with a hairloss product to talk about Phase III since Proscar in the mid-90's(although you can count DUT last year but that is an archaic drug as well).

If a company is talking about Phase III with a hairloss drug, it is massive news for the industry, it all but guarentees a new product on the market as it means they had great efficacy in the 2nd phase. 

Only products close to this are BIM(which is in another Phase IIb), Histogen(which looks to skip phase III by using other countries) and of course SM which is still fairly mysterious.

----------


## Hemo

> There hasn't been a single company with a hairloss product to talk about Phase III since Proscar in the mid-90's(although you can count DUT last year but that is an archaic drug as well).
> 
> If a company is talking about Phase III with a hairloss drug, it is massive news for the industry, it all but guarentees a new product on the market as it means they had great efficacy in the 2nd phase. 
> 
> Only products close to this are BIM(which is in another Phase IIb), Histogen(which looks to skip phase III by using other countries) and of course SM which is still fairly mysterious.


 Yup.  The other thing that intrigues me about SM is that their participants had higher norwood levels, so if they're reporting efficacy then it should work for a good number of balding folks.

----------


## BoSox

What will this do for a Norwood 3? I'm currently a NW 2.22222222. Thinning getting worse on top. Will I benefit from SM04554?

----------


## Dimoxynil

> What will this do for a Norwood 3? I'm currently a NW 2.22222222. Thinning getting worse on top. Will I benefit from SM04554?


 No one knows for sure yet mate. Some people are optimistic but with no real reason. If they move into phase 3 then as others have pointed out that would be a good enough reason for optimism. 

Stay neutral would be my advice and don't expect miracles

----------


## IvanXproject

Is there ANY chance that SM will be able to skip phase III? And when will their extended study end? March?

----------


## Hemo

> Is there ANY chance that SM will be able to skip phase III? And when will their extended study end? March?


 In my eyes, no, but who am I to really say.  But wait for the 21st century cures act to actually pass before you get too hopeful.  We also have yet to see how effective SM is, so everything is up in the air.

----------


## Tomtom21

welp here it is boys... if any of you ****ers live in d.c you must attend that aad conference on march 5th i repeat march 5th. it is a saturday. samumed will be presenting phase II results according to the program information which can be found here:
https://www.aad.org/scientificsessio...s.aspx?id=9717
you guys can thank me later and lets ****ig hope this shit is what were all hoping boys!

----------


## champpy

Good find tomtom! 
Roughly two weeks away from knowing if we have any hope at all.. this is making me oddly nervous. Im so afraid that either the results will be subpar or they are going to announce a further delay and more phase 2 testing...
Honestly if a high norwood shows 15 to 20% improvement ill be happy as hell and call this a huge success. 
Im fearing a histogen type of improvement though  :Frown:

----------


## TooMuchHairWontKillYou

> welp here it is boys... if any of you ****ers live in d.c you must attend that aad conference on march 5th i repeat march 5th. it is a saturday. samumed will be presenting phase II results according to the program information which can be found here:
> https://www.aad.org/scientificsessio...s.aspx?id=9717
> you guys can thank me later and lets ****ig hope this shit is what were all hoping boys!


 Woow can't wait to hear news from them  :Big Grin:  
My hopes are very realistic. I think SM will be able to reverse max 1.5-2nw and thats very big deal I think ^_^

----------


## Seuxin

Regaining 1nw will be already amazing...  :Smile:

----------


## xyz123

> welp here it is boys... if any of you ****ers live in d.c you must attend that aad conference on march 5th i repeat march 5th. it is a saturday. samumed will be presenting phase II results according to the program information which can be found here:
> https://www.aad.org/scientificsessio...s.aspx?id=9717
> you guys can thank me later and lets ****ig hope this shit is what were all hoping boys!


 Nice find!  The AAD is a huge meeting - way, way, way bigger than the Hair Congress.  And their study is being presented as part of the late breaking research session - generally the most coveted and publicized spot.  As the website states, this session is for "ground-breaking scientific developments in dermatologic research".  And they are first among the whole line-up.

Samumed's trial is essentially front and center at this meeting.  You've gotta believe that they have some compelling results. 

All reasons to be very, very optimistic.  Assuming the results look good, I suspect this will be all over the news.  Excited.

----------


## Tenma

Great! They choose to present results at a very prestigious event.

Cant wait

----------


## Reign

I will be at the meeting. Will let you know what information is released.

----------


## SriHanuman

Keep in mind that they were applying it only for 3 months.

----------


## BoSox

What's expected of this treatment? I'm guessing it won't regrow temple hair, but a better Minox type treatment?

----------


## Spaceboy

We don't know what it will regrow exactly, but they did have high Norwoods in the test group. They claimed to have decently good results too. So... Time will tell. Like everything else

----------


## champpy

I take back my last post... if the drug didnt produce somewhat good results i cant imagine them presenting this in this way. Seems they are very confident in their product

----------


## burtandernie

Lets hope its good. A new treatment is just what the doctor ordered. Also maybe more exciting is it will define the future direction of further research much like propecia did back when it came out. Think how many years after propecia and even today the amount of research that went into AAs and androgens thanks to propecia. Big new treatments set the standards and define future paths.

----------


## Trouse5858

> We don't know what it will regrow exactly, but they did have high Norwoods in the test group. They claimed to have decently good results too. So... Time will tell. Like everything else


 I'm not sure you can read a whole lot into the participants' norwoods. It's just much easier to track, observe and photograph regrowth on patients who have less hair on their scalps. Even if the new hair that pops up doesn't make the person look drastically better overall, it's easier to definitively show that new hair has grown and it's not just lighting/ a combover. 

In any event, I want to be optimistic but the presentation is only going to be 12 minutes long? That doesn't sound like enough time to truly delve into the science behind a potential breakthrough drug in the industry or raise more funds from investors. Hopefully I'm wrong.

----------


## xyz123

> I'm not sure you can read a whole lot into the participants' norwoods. It's just much easier to track, observe and photograph regrowth on patients who have less hair on their scalps. Even if the new hair that pops up doesn't make the person look drastically better overall, it's easier to definitively show that new hair has grown and it's not just lighting/ a combover. 
> 
> In any event, I want to be optimistic but the presentation is only going to be 12 minutes long? That doesn't sound like enough time to truly delve into the science behind a potential breakthrough drug in the industry or raise more funds from investors. Hopefully I'm wrong.


 Don't worry about the length of the presentation.  This is a prestigious international academic conference and Samumed has been selected to present their results.  It's the conference that dictates the presentation duration - not Samumed - everyone in that session gets 12 minutes.  This is standard for any international conference - this is how important trials get reported these days.  If the results are big, they'll get a ton of press - and everything else will follow.  This whole development is very, very encouraging.

Contrast this to Allergan's treatment of Bimatoprost - they weren't presenting those results anywhere - they snuck them into the middle of a quarterly report.

Samumed is front and center at the world's biggest annual skin conference.  You've gotta believe they've got something that they are excited about.  To note - their osteoarthritis results that got a lot of publicity were posters at a conference - posters are not prestigious at all.  Getting to present your results at a late breaking session - whole different level. 

This time - we've got reason to be excited.

----------


## rdawg

> I take back my last post... if the drug didnt produce somewhat good results i cant imagine them presenting this in this way. Seems they are very confident in their product


 Judging by the way they talked about it(back in December they said they had significant response to the drug and we're talking NW4+ type of people, which would include diffuse thinners and such)

Very promising, we already know the results weren't bad, I dont know why anyone thinks that(as they claimed to see significant regrowth) it's a matter of how good they actually were.

If it's a continued growth, this would be amazing, if it's only an initial response which bumps you up a norwood or something, then it's still more promising than anything on the market.

I'd say it's time to get fairly excited here.

----------


## rdawg

Again just posting this article again, http://www.businesswire.com/news/hom...t-Hair-Density

They already stated significant statistical hair growth after a 135 day study(4.5 months), if the product worked continuously, then they would be seeing continued results even later. 

There is no bad news coming here, even in this ariticle it says they've seen enough to want pivotal(phase III) trials. 

the question is, is this a major breakthrough in regrowth(not necessarily a cure, but something that has a major effect), or just a small step forward( a super minoxidil).

----------


## Cartech78

My fingers are crossed , i hope this is a home run . My qeustion is , how long to get it to the market if its the real deal .

----------


## BrianH123

I'm slightly confused.. I read that study that was published In December just now, and it says , to sum it up, positive results on Norwood 4 and greater. So why is there hype now, and not directly after the hairless conference? I've read somewhere they are posting something in early  March, is this the actual hair % increase and density growth, pictures, or what ?

----------


## rdawg

> I'm slightly confused.. I read that study that was published In December just now, and it says , to sum it up, positive results on Norwood 4 and greater. So why is there hype now, and not directly after the hairless conference? I've read somewhere they are posting something in early  March, is this the actual hair % increase and density growth, pictures, or what ?


 No it was just a preview back in december, there was hype back then as well(cautious optimism for the most part)

The fact that they were near the end of the trial and seeing positive results, then stating they were going to review the results further and right away releasing those results is an incredibly good sign.

usually when it's been bad news, there has always been a delay, but with this product they have been vocal for a few months about it, and that article just mentions that they are seeing very positive results.

The exact results will be heard in less than two weeks, we know it's good, but how good is the question!

----------


## Hubris

> The exact results will be heard in less than two weeks, we know it's good, but how good is the question!


 I think we have to assume that the results are at least better than minoxidil. If the results were less than or equal to minoxidil, it would be unlikely that they would wish to pursue further clinical trials. Thus, there is definitely room here for cautious optimism.

----------


## Hemo

> I'm slightly confused.. I read that study that was published In December just now, and it says , to sum it up, positive results on Norwood 4 and greater. So why is there hype now, and not directly after the hairless conference? I've read somewhere they are posting something in early  March, is this the actual hair % increase and density growth, pictures, or what ?


 That was a preliminary release within 2 weeks of the conclusion of their trial.  They since did more thorough analyses, which are being presented on 3/5.

----------


## Tomtom21

I think we all need to just take a minute and take a deep breathe bc we are all getting ahead of ourselves. We are going to find out in 11 days so patience people. It is hard to believe that the trial did not produce at the very least superior results to minoxidil, but all at this time is pure speculation. We are all hoping for the crap your pants, mind blowing results, but time will tell. If it is one thing we have learned from AGA, with all these treatments and hopes, is hope for the best, but expect the worst. 
Lastly, I really think that they have something (I wont speculate as to what I think that is), but we also need to be circumspect bc wnt pathway is a/w cancer risks. This supplemental trial will further support a safety profile or **** the product all together (similar occurrence with the product from curis years ago - it was effective but carcinogenic and therefore trashed). So everybody keep their heads on their shoulders and lets just wait and see.

----------


## burtandernie

I think results equal to minox if just by a different method would still be worth pursuing. Regrowing hair is so hard to do I think anything remotely significant is worth going after. You could always stack this and minox and get double the results. Just have your wallet ready the stuff wont be cheap

----------


## rdawg

> I think results equal to minox if just by a different method would still be worth pursuing. Regrowing hair is so hard to do I think anything remotely significant is worth going after. You could always stack this and minox and get double the results. Just have your wallet ready the stuff wont be cheap


 Minoxidil is borderline garbage, it was worth selling back in the 80's-90's as there were literally zero alternatives and it maybe gave you a 10% improvement(more on very few patients).

it did nothing for me and numerous others, gives a slight thickening affect if anything.

there is no way to sell a product like minoxidil, at the very least this is 10-20% better going by that article from december, but we dont know how much better.

and yes as above said, Everything revolving around this drug has been good so far, and we know it's better than minox(they said they achieved results on late stage hairloss guys, not early stage like minox) but safety is a massive concern which will take at least a year long trial to figure out with a product like this which affects the WNT pathway.

hopefully they pursue a phase III right away though, meaning this product would be 2 years away max.

----------


## Trouse5858

Is one year the average length trial for a phase III? I feel like I've read about some that were upwards of 2 years. And what's the latency period in terms of getting it to market, like what's the final step after this trial?

----------


## IvanXproject

Does anyone think that SM could potentially have worse side effects than finasteride? What kind of side effects could we expect from this type of drug?

----------


## s991

> Does anyone think that SM could potentially have worse side effects than finasteride? What kind of side effects could we expect from this type of drug?


 Cancer

----------


## IvanXproject

> Cancer


 That is way worse than the finasteride side effects..

----------


## rdawg

> Does anyone think that SM could potentially have worse side effects than finasteride? What kind of side effects could we expect from this type of drug?


 Nothing has been found to be dangerous with this drug yet from the 1.5 years it's been in trial.

Cancer is a major related possibility, but there is no evidence of this drug causing that yet at all, they believe the molecule does not stay in the system long enough to cause something like that.

Believe me they would discover something like that before it's release, you would notice that after 3 years or so of trials.

----------


## allTheGoodNamesAreTaken

How often does this chemical get applied? Once a day?

----------


## Hemo

> How often does this chemical get applied? Once a day?


 I believe the trials have been once per day but who knows until it's potential release.

----------


## machi

after the disappointment of yesterday the results of CB- 03-01 , is it possible to get samumed in the same way that we can use CB- 03-01 ? I mean if we can get samumed in Kane or another laboratory.
I can not wait any longer , I 'm going bald and I can not go outside without toppik .

----------


## dm90

I'm cautiously optomistic about this drug.  I found this article that links miRNA 214 with hair cycling and forming via the WNT/B-catenin.  
*
miR-214 exhibits differential expression patterns in the skin epithelium, and its inducible overexpression in keratinocytes inhibited proliferation, which resulted in formation of fewer HFs with decreased hair bulb size and thinner hair production.*

That sounds like hair miniaturization to me.

*The inhibitory effects of miR-214 on HF development and cycling were associated with altered activities of multiple signaling pathways, including decreased expression of key Wnt signaling mediators β-catenin and Lef-1, and were rescued by treatment with pharmacological Wnt activators.*

Sorry if this was already posted.  Ive read the entire thread a few times, but alot of stuff has been posted and I cant remember every single study.  I dont know if this is linked to AGA, but there are multiple studies that show that DHT significantly inhibits WNT/b-catenin in DP cells of men with AGA, it does not do this to men without AGA.  The first study I posted seems to say that the HF cycling and development problems can be RESCUED with WNT activators.  Would any of you hard science guys like to take a stab at this?  My molecular biology is a bit rusty.

----------


## IvanXproject

> after the disappointment of yesterday the results of CB- 03-01 , is it possible to get samumed in the same way that we can use CB- 03-01 ? I mean if we can get samumed in Kane or another laboratory.
> I can not wait any longer , I 'm going bald and I can not go outside without toppik .


 I guess it would be possible if they released the chemical structure

And if they don't, we'll have to wait until 2018/2019... which is way too long in my opinion

----------


## BoSox

> I can not wait any longer , I 'm going bald and I can not go outside without toppik .


 I'm with you. I needed something 5 years ago.... now I'm a NW 2.5ish with serious diffuse thinning, it's taking more and more derrmach to cover it.

Can we at least get a medication to reverse what we have now before we ****ing lose it? CMON.

----------


## IvanXproject

Is it likely that they will release their chemical structure next saturday?

----------


## Hemo

> Is it likely that they will release their chemical structure next saturday?


 Very unlikely IMO.  Why the hell would they?

----------


## dutchguyhanging

> I'm with you. I needed something 5 years ago.... now I'm a NW 2.5ish with serious diffuse thinning, it's taking more and more derrmach to cover it.
> 
> Can we at least get a medication to reverse what we have now before we ****ing lose it? CMON.


 look, always said and will say again. there is NO such thing as to reverse what you have now. thats for the likes of fin +minox...etc

as long as there is no cure coming out, we will ALWAYS lose ground... without doubt..

so again there WILL BE NO such medicine that will guarantee you to maintain what you have...

----------


## IvanXproject

> Very unlikely IMO.  Why the hell would they?


 Idk man...

I just want to get a hold of this before 2018... 

Maybe the structure is in here: http://www.google.com/patents/US20140080902

----------


## BoSox

> look, always said and will say again. there is NO such thing as to reverse what you have now. thats for the likes of fin +minox...etc
> 
> as long as there is no cure coming out, we will ALWAYS lose ground... without doubt..
> 
> so again there WILL BE NO such medicine that will guarantee you to maintain what you have...


 Your saying we can't reverse thinning hair, unless we have Fin or Minox? What about SM04554? Isn't that a better Fin or Minox?

----------


## Hemo

> Your saying we can't reverse thinning hair, unless we have Fin or Minox? What about SM04554? Isn't that a better Fin or Minox?


 Jesus, you've been here since 2010 and still believe these kinds of claims? We have no idea how effective SM04554 is.  Did anyone conclusively say it is?  No. 

People are excited because researchers claimed it's poised to move into phase III.  Hopefully that means it's better but no one has a clue at this point.

----------


## dutchguyhanging

> Your saying we can't reverse thinning hair, unless we have Fin or Minox? What about SM04554? Isn't that a better Fin or Minox?


 no i am saying as long as u dont make NW0 from NW7, all treatments will go down the drain. u need a full proof cure.

in other words, there will be always side effects if u dont come up with full cure. because u r not tackling the real issue.

as you may think, SM might be better than Fin for SOME PEOPLE. however FIN will still show better results for the other. they wont be statistically different of each other

aging plays a role in hair loss thats why SM needs to show hell alot of better results than this. I am not convinced at all with the hype.

----------


## dm90

> look, always said and will say again. there is NO such thing as to reverse what you have now. thats for the likes of fin +minox...etc
> 
> as long as there is no cure coming out, we will ALWAYS lose ground... without doubt..
> 
> so again there WILL BE NO such medicine that will guarantee you to maintain what you have...


 Except there are plenty of studies that show the persistent benefits of long term finasteride use.  Yes I'm aware of the drop in hair count at the five year mark, however you have to remember that there is still 10% type II in the DPC.  I would be willing to wager that drop in hair count would not occur in a long term dutasteride study.  AGA has a very complex pathology, but there are still major players in its development.  DHT is without a doubt the strongest driving factor that we've discovered.  The reason I'm excited about WNT/B-catenin modulation is because it has the potential to be another major player in AGA.  Specualtion is completely pointless, we will know the results in five days.

----------


## burtandernie

I have never been fully convinced aging causes MPB. If it was every man and woman would be affected, but its clearly not the case. There are men and women that are like 60 with almost zero hair loss. Clearly its something yet to be understood, and I do think androgens are a huge huge player in it. We dont even really have a perfect AA to even look at for an ideal scenario of what androgens really do. Maybe dut but even that spikes T a lot which is also an androgen so even dut isnt perfect

----------


## champpy

We are just 3 days away from getting an idea if SM is going to be a savior or just a slight upgrade from current treatments.

I for one am getting nervous as hell, im so afraid that if we get any photo proof it will be underwhelming. This is really the only thing we may have in the next 2 years, i think we all need to send good vibe out this weekend, hope for the best but be prepared for the worst.

Please dont let is down Samumed :Roll Eyes (Sarcastic):

----------


## wolfbeaver

We also have no idea how affordable this will be. This treatment could potentially cost overs $1000 per year. Many snake oil products succeed at this price. So if this actually has evidence behind it I would expect it to go for even more.

----------


## kantian

> We also have no idea how affordable this will be. This treatment could potentially cost overs $1000 per year. Many snake oil products succeed at this price. So if this actually has evidence behind it I would expect it to go for even more.


 Wasn't Propecia that expensive when it was first sold? Some people still pay $60/mo ($720/yr) for their generic finasteride. I'd be willing to pay that much and more. That's not a difficult amount of money to acquire for most people in rich countries.

----------


## dm90

> Wasn't Propecia that expensive when it was first sold? Some people still pay $60/mo ($720/yr) for their generic finasteride. I'd be willing to pay that much and more. That's not a difficult amount of money to acquire for most people in rich countries.


 Propecia was like 120-150 when it came out.  Aesthetic topical tend to be very expensive, look at acne treatments.  If this is effective and comes out I'd expect at least 150 a month.  Hell I don't care though

----------


## dm90

If this is only a slight upgrade from minoxidil that would still be massavie. You have to remember minoxidil works wonders for a small percent of people.  If sm could give a full min result to a large group of people that would be incredible.  Mins growth potential isn't really the issue.  It's the response rate

----------


## dm90

Last thing I'll say is that if expect any results from this drug to be greatly increased with fin.  We've all heard the "releasing the breaks and stepping on the accelerator" analogy.  Well dht inhibits the pathway and sm supposively up regulates it.  That actually fits the comparison exactly.

----------


## Tenma

> If sm could give a full min result to a large group of people that would be incredible. Mins growth potential isn't really the issue. It's the response rate


 Couldnt agree more.

----------


## Alias123

Updates from yesterday?

----------


## IvanXproject

The day has come. Is anyone here attending?

----------


## machi

Please , publish any news that is known today samumed . I'll read to you from Spain . Fingers crossed because we have good news.

----------


## Swooping

Very lackluster results guys... Really sucks, hope that is a troll post from forbes. 

http://www.forbes.com/sites/matthewh.../#539ff5401600

----------


## Cartech78

Yeah ,not as good as i was hoping for but who knows , this drug used with fin and minoxidil , maybe they have somoething

----------


## Hubris

> Yeah ,not as good as i was hoping for but who knows , this drug used with fin and minoxidil , maybe they have somoething


 They grew less than ten hairs.

----------


## Cartech78

10 in a 1cm square area , they also did not metion if it made other existing hair stronger. I never expected this to be a cure , im just looking for a little more help then what is out there already. Besides growing 10 hairs is a start, its better then growing 0.

----------


## Trouse5858

> They grew less than ten hairs.


 Ten hairs on a 1 cm squared surface area. That's not great but it's something. Dosing looks like it could be an issue though.

----------


## Sogeking

Thats it. Unless Histogen wasn't fudging with their results  despite their pictures being suspicious, no upcoming treatments are gonna matter that much. The results from SM are lackluster.
We're gonna have to wait for Tsuji or LAusters team to produce new hair follicles in lab which is like 10+ years away.
Since Bimatoprost, Sm, CB and Seti haven't really shown us anything worth noting I think it is time for me to shave it off and try to go off the forums...

----------


## Hubris

> Ten hairs on a 1 cm squared surface area. That's not great but it's something. Dosing looks like it could be an issue though.


 Yes, ten hairs in a 1cm squared surface area. Let's be realistic, these results are a massive disappointment, and it's unlikely now that this drug will ever come to market.

----------


## Cartech78

I know it sucks that this study didnt produce better results , part of me was hoping for more then we got too, but every time companies do these studies more is learned then we knew before and i believe that it inches us closer to a cure. Picture what 10 hairs would look like in a 1cm square looks like! That is better in my opinon then what minoxidil has ever done for me .

----------


## BoSox

Trash results. Especially if this drug isn't coming out for at least two years. I'm officially done with this forum, nothing is coming out within the next few years unless it's a miracle. Not going to waste my youth anymore on this bs.

----------


## jamesst11

it sucks, but you're dismissing it too soon.  10 hairs / cm2, after THREE months... who even gives a sh*t after three months?? How long did it take you to REGROW TERMINAL HAIR on finasteride, minoxidil, etc... sure there are always some amazing responders, but this showed halt of loss and 10% regrowth in 3 months, and through a completely different pathway.  I am actually impressed.  That is because I keep my expectations extremely low.

----------


## willy

10 hairs in 1cm square at 3 months? What about 6 - 12 months, while the hair cycles? If they're vellous hairs than this is nonsense.. but terminal ? Maybe not THAT bad? If it works in the hairline / temples that would be ok too imo.

----------


## beetee

We all want an overnight cure and a guarantee but unfortunately that's not on offer and not often the way scientific research advances. If we're alive and a cure comes out, we're really lucky; no other bald/balding people from previous generations have had that opportunity. If it's working on any level, that's good. If they're continuing to do research, that's good. This isn't a set back. We have the same thing we had yesterday; they've done research, they've had some positive results, and they're going to keep working at it.

----------


## beetee

Also, I get the impression that the Forbes piece was not written in response to the actual presentation but based on a preview they received from Samumed before the conference. For those reacting very negatively, I would suggest at least waiting until we get access to some of the materials and information that were actually presented at the conference itself, not just this preliminary review.

----------


## Trouse5858

> We all want an overnight cure and a guarantee but unfortunately that's not on offer and not often the way scientific research advances. If we're alive and a cure comes out, we're really lucky; no other bald/balding people from previous generations have had that opportunity. If it's working on any level, that's good. If they're continuing to do research, that's good. This isn't a set back. We have the same thing we had yesterday; they've done research, they've had some positive results, and they're going to keep working at it.


 I just can't share the optimism. We're lucky if a cure comes out when we're [B]alive[B]? So if you're 65 years old, and the "cure" comes out, that's a victory in your mind? Even though it won't have any affect on your life?

 All I want is a goddamn treatment that can slow down my hairloss without castrating me so I don't have to worry about my hairloss every time I go to the beach, or a bar, or ride in my friends jeep with the roof off. Until then, I'm just going to be completely unable to enjoy most activities to the fullest. Maybe 70 percent, while the other 30 is worried about how shitty I look. That might be ridiculous and shallow but it's a fact and nothing about my willpower can change it.

----------


## Tenma

Shit, didnt expect those numbers.

The only hope is the time frame, 3 months is too early for most treatments.

Maybe it can show better results on lower NWs also?

----------


## IvanXproject

Maybe we could get this made in a laboratory? (like CB, RU, Seti etc.) 

It will probably work better on lower NWs and if you use it for a longer period of time

----------


## beetee

> I just can't share the optimism. We're lucky if a cure comes out when we're [B]alive[B]? So if you're 65 years old, and the "cure" comes out, that's a victory in your mind? Even though it won't have any affect on your life?
> 
>  All I want is a goddamn treatment that can slow down my hairloss without castrating me so I don't have to worry about my hairloss every time I go to the beach, or a bar, or ride in my friends jeep with the roof off. Until then, I'm just going to be completely unable to enjoy most activities to the fullest. Maybe 70 percent, while the other 30 is worried about how shitty I look. That might be ridiculous and shallow but it's a fact and nothing about my willpower can change it.


 I hear you and I feel your pain, but there's no reason to think there ever will be a cure. They could try for a 1,000 years and never be able to crack it. What if it's impossible? That could very well be the situation. So, yes, if we experience a cure in our lifetimes, that would definitely be amazing. I don't know if you're relatively new to this or not (it's all relative, I'm not trying in any way to diminish your experiences) but I've been dealing with it for 16 years so I know the difficulties involved in trying to live your life not being consumed by the fact that you can't enjoy activities to the fullest. Got to do the best you can to make what you have work for you though; it's still your life and you have to live it for as long as you're alive, and it's going to go by one way or the other. If being pissed and upset about it grew back hair, trust me, I'd be walking down the street during a hurricane with the proudest, thickest pompadour you've ever seen!

Also, I know strategically employing hats in challenging environments can feel like you're crossing a line that you'd rather not but my life got about a million times easier when I started pulling one out for the kind of situations you mentioned.

----------


## Tenma

> Also, I get the impression that the Forbes piece was not written in response to the actual presentation but based on a preview they received from Samumed before the conference. For those reacting very negatively, I would suggest at least waiting until we get access to some of the materials and information that were actually presented at the conference itself, not just this preliminary review.


 Reading the article again, it is certain he wrote it before the presentation.

But the data was apparently reviewed by doctors who had previous access to the presentation

I think we should wait for official info before rushing into conclusions

----------


## Waiting4Cure

I have been lurking this forum for 4 years now and after subpar results of other drugs (CB, Bim, Seti, etc) I am eagar to hear any news on SM04554.

Granted, "only" 10 more hairs from 1cm squared is a very minor improvements and can be disappointing to hear at first sight.

*However, we gotta remember that they only recruited NW4+ patients for their Phase 2 study and its result is only at 3 months.*

This means that results can get much better if you are below NW4 and take it for more than 3 months as most implanted hairs don't even grow in 3 months. 

Also, avg pt hair density per 1cm squared was 110 hairs thus 10 hairs was a 10% increase of density.

Last but not least, the placebo group had decrease of hairs (5 hairs) which suggests that SM can maybe maintain hairs as well.

Overall not the greatest result we all anticipated but still too early to cross SM off our list as others are saying here.

----------


## dm90

I'm still interested in Sammumeds official statement and results on the drug.  Because the forbes article also says they are trying to proceed into further trials for approval.  I'm not speculating on anything but if the results were really that poor, I cant imagine them continuing with trials.  Hopefully we will here something from them soon.

----------


## Spaniards

Hi! I still think they can make it, that´s not a significant improvement but let them do their job. It has been only a three months trial, so please do not draw conclusions from that. 

I have read something about April in a different forum. What are they gonna do then? Any clue? Thanks guys and do not give up, we are on this together! We all want a cure, but it seems we have to wait... At least for a while!

----------


## Thinning@30

Having a tough time accepting this, but I also want to wait for the official announcements before I jump to conclusions.  I don't see why Samumed would go to the trouble of presenting at a conference not to mention all the "hinting" about decent results if they knew the results were actually lackluster and were considering not moving forward with SM04554.  Wouldn't it make more sense to just quietly shut down the project and move on?  Then again, Aderans and Washenik were totally enthusiastic about ARI right up until the day they liquidated the lab sold off the equipment.

This whole thing feels just like what happened when Replicel first announced their trial results.  Huge letdown and then months later they released a bunch of statements trying to convince us that things weren't as bad as they looked.

I'm grasping for ways to maintain hope here.  Could SM04554 give truly effective maintenance if not regrowth? Will results be better at six months or one year? Could it have a synergistic effect with minox or fin?  Could it be used with hair transplants to make transplants a better option?

----------


## mayapple

> Having a tough time accepting this, but I also want to wait for the official announcements before I jump to conclusions.  I don't see why Samumed would go to the trouble of presenting at a conference not to mention all the "hinting" about decent results if they knew the results were actually lackluster and were considering not moving forward with SM04554.  Wouldn't it make more sense to just quietly shut down the project and move on?  Then again, Aderans and Washenik were totally enthusiastic about ARI right up until the day they liquidated the lab sold off the equipment.
> 
> This whole thing feels just like what happened when Replicel first announced their trial results.  Huge letdown and then months later they released a bunch of statements trying to convince us that things weren't as bad as they looked.
> 
> I'm grasping for ways to maintain hope here.  Could SM04554 give truly effective maintenance if not regrowth? Will results be better at six months or one year? Could it have a synergistic effect with minox or fin?  Could it be used with hair transplants to make transplants a better option?


 3 MONTHS and every one is depressed and losing hope.  It was stupid of them to announce results after such a short period of time.  I am assuming they did so because of trial regulations, or promoting their company or some crap.  Hair cycling and growth is painfully slow.  Fin takes up to a year to see results.  Minoxidil six months to a year.  Lets calm down and see what happens before throwing in the towel.

----------


## dm90

Honestly after thinking about it, I'm feeling positive about all if this.  I mean 90 days is really way to short, but we still saw a minor improvement.  I could see them going into a large phase 3 trial with application for 12 straight months.  I really think they will continue with the trials.  But I do hope they do mutliple control groups, with at least one group using sm and fin.  I think combination therapy is imperative.

----------


## allTheGoodNamesAreTaken

OK, so 10 hairs per square cm isn't anything too exciting... BUT it's ten more hairs than any snake-oils have been capable of. Maybe different doses, maybe more time required to see better results, maybe used in combination with something else. At the very least it confirms the science that motivated trying this approach. In fact... forget about regrowth, even just a reliable maintenance would be great. If that's what this turns out to be, I'll take it.

----------


## TravisB

OK, so does anyone know when they will publish the official presentation?

There will probably be pics included

----------


## bboyforever

I'm not sure why no one has pointed this out yet, but the obvious question is how these results scale. We could be talking: 

10% at 3 months 
20% at 6 months
40% at a year 
80% at 2 years

You've got to keep in mind we're dealing with a new pathway here that is about as downstream the cascade as we've ever gone. There's been some good solid theory about why other treatment modalities hit a brick wall, and it's usually because of some downstream effect. The limiting effect here might just be the physical growth rate of the hair follicle itself. 

Everyone is assuming these results are logarithmic, that they taper off, (like fin and minox). What if, in fact, they're linear? Good god, what if they're exponential?  

Until some guys actually start dropping some science about what these results actually mean, taking the most facile and pessimistic view is really people wallowing in playing whiny victim bitches. And don't start posting all your little emotional tantrums because your emotions don't mean shit, I just want the data.

----------


## dus

This product would be great for me as an add on to fin. If it gets released within 2 years I will be very happy. NW 7's are ****ed and should just accept it imo. Stop wasting your time on these depressing forums. If you really want hair as a 7... do the front + mid at a proper clinic and accept the bald spot on the back. My two cents.

----------


## Tomtom21

theres so many negative thoughts regarding this since weve been burned so many times in the past.
first point the trial was breif 3 months... not really adequate time to assess how good of regrowth agent this is. 
second point it definitely created skme regrowth 10% which is eh but if we kitchen sink our heads 10 from sm 10 from cb plus maintenance plus 20 from min is 40%. you cant expect this to be an end game cure gotta keep your hopes realistic. also this product would obviously be better for diffusers. realistically we need a product that can create greater regrowth so HT can be more aesthetic at this stage in the game. 
the one negative that worries me is the poor dose response curve and how it plateued at such a low dosage. hang tight my fellow baldies

----------


## Dimoxynil

> This product would be great for me as an add on to fin. If it gets released within 2 years I will be very happy. NW 7's are ****ed and should just accept it imo. Stop wasting your time on these depressing forums. If you really want hair as a 7... do the front + mid at a proper clinic and accept the bald spot on the back. My two cents.


 If your a NW7 you should go for an SMP/FUE combo IMO it's almost a no brainer

----------


## baldybald

> If your a NW7 you should go for an SMP/FUE combo IMO it's almost a no brainer


 Completely agree

----------


## burtandernie

I think we need to see 12 month results before drawing conclusions. Not sure whats the point in even releasing 3 months results its almost meaningless because results can change so much in 6 more months. Everyone responds differently, but it takes a lot longer then 3 months

----------


## Seuxin

Hello Guys,

Do we have the formula, or a new patent ??
I ask this in order to know if we can copy it ?

SO, they go on P3 ?

----------


## joel203

does anyone have any sort of an idea when we will hear an official statement from sammumed ? I also heard on the *** forum that someone said theyre reconsidering dosage so are starting things from scratch? can anyone confirm this

----------


## allTheGoodNamesAreTaken

> If your a NW7 you should go for an SMP/FUE combo IMO it's almost a no brainer


 This is something I've been wondering about because SMP on its own looks shit when close up (and the hairlines I've seen are generally awful too) and obviously won't feel like little hairs if touched... but getting a diffuse-ish FUE done and with SMP sounds plausible. Not quite sure why this isn't a popular thing already... maybe there should be a thread on it if there isn't one...

----------


## Dimoxynil

> This is something I've been wondering about because SMP on its own looks shit when close up (and the hairlines I've seen are generally awful too) and obviously won't feel like little hairs if touched... but getting a diffuse-ish FUE done and with SMP sounds plausible. Not quite sure why this isn't a popular thing already... maybe there should be a thread on it if there isn't one...


 From what I've seen just browsing SMP forums, the results can look VERY good. Just having some real hair around the hairline can give a very realistic look. I saw one guy who used just 800 grafts to replicate a hair line and the rest was standard tricopigmentation. I'm quite amazed that there's no great interest in it on here.

----------


## IvanXproject

> Hello Guys,
> 
> Do we have the formula, or a new patent ??
> I ask this in order to know if we can copy it ?
> 
> SO, they go on P3 ?


 It's in here I think: http://www.google.com/patents/US20140080902

----------


## rambo007

> I saw one guy who used just 800 grafts to replicate a hair line and the rest was standard tricopigmentation.


 Could you post a link to that case? I would be very grateful.

----------


## allTheGoodNamesAreTaken

> From what I've seen just browsing SMP forums, the results can look VERY good. Just having some real hair around the hairline can give a very realistic look. I saw one guy who used just 800 grafts to replicate a hair line and the rest was standard tricopigmentation. I'm quite amazed that there's no great interest in it on here.


 It actually sounds like a good solution the more I think about it. Officially my plan B now, since it's probably still possible even for people with weak donor region. Not as good as thick, flowing locks but vastly better than a half-bald head with no hairline.

----------


## Dimoxynil

> Could you post a link to that case? I would be very grateful.


 Will try and find it

----------


## PatientlyWaiting

> From what I've seen just browsing SMP forums, the results can look VERY good. Just having some real hair around the hairline can give a very realistic look. I saw one guy who used just 800 grafts to replicate a hair line and the rest was standard tricopigmentation. I'm quite amazed that there's no great interest in it on here.


 I actually have interest in that, and I know what you are talking about, not the case, but the concept. I've been interested for the past year. Only thing is I wanna do the whole head including filling in the donor area to make it appear fuller, which would cost about $4,500 or so (for the whole head).

----------


## Dimoxynil

> I actually have interest in that, and I know what you are talking about, not the case, but the concept. I've been interested for the past year. Only thing is I wanna do the whole head including filling in the donor area to make it appear fuller, which would cost about $4,500 or so (for the whole head).


 The thing I like most about the concept is the low-risk element. If the FUE doesn't go so well (which it should do anyway) then you still have the SMP which should still look realistic enough if you use the right practicioner. If you use tricopigmentation then you have an exit strategy if the SMP doesn't give you what you want. So it's far from an all or nothing option. You almost have nothing to lose by going for it

----------


## allTheGoodNamesAreTaken

> The thing I like most about the concept is the low-risk element. If the FUE doesn't go so well (which it should do anyway) then you still have the SMP which should still look realistic enough if you use the right practicioner. If you use tricopigmentation then you have an exit strategy if the SMP doesn't give you what you want. So it's far from an all or nothing option. You almost have nothing to lose by going for it


 Yeah that's what I was thinking. I feel quite a bit more relieved after this realization. Actually it could also just be a back-up plan if a FUE on its own goes wrong. I would get the temporary 2 year tattoo though, **** gambling on a permanent one that could change colour after a while.

----------


## Dimoxynil

> Yeah that's what I was thinking. I feel quite a bit more relieved after this realization. Actually it could also just be a back-up plan if a FUE on its own goes wrong. I would get the temporary 2 year tattoo though, **** gambling on a permanent one that could change colour after a while.


 Yes, temp SMP is a far more sensible option to me. I shave my bloody head anyway so it's not like it going to radically alter my look. Fred the Belgian and Spex know more than me about this stuff though.

----------


## champpy

No offense guys, but can we stay on topic here?

Im so confused by what SM is trying to do. Their whole phase 2 was only 3 months? How is that possible when it seems they were extending it over and over?

Do all researchers who are in a clinical trial have to present in such a public way? If this is less than stellar, why present this at a conference, couldnt they just have released the results online? 

And, why the hell would they be a sponser at the hair congress if they dont assume they can capitalize on it down the road? Where they counting their chickens before they hatched?

So many of their moves sounded encouraging but to have to restart phase 2 again is a kick in the teeth, and it may yeild no better results than we see now.

----------


## allTheGoodNamesAreTaken

That's enough thread hijacking for me, back to SM04554!!!

----------


## dutchguyhanging

> That's enough thread hijacking for me, back to SM04554!!!


 results are published. they promise 10% in 3 months hahaha
another charade .. yo all remember the pitch from fin right? yes it was around 40% close to 50%... so it probably makes 1% affect in reality which would not be cosmetically viable anyways.
so what do you say guys? shall we ask admin to lock this thread...

I now believe we have talked about SM even more than the scientists working for SM  :Smile: 
probably they werent even aware that so many people were waiting/talking otherwise they wouldnt have published such funny results

----------


## beetee

> No offense guys, but can we stay on topic here?
> 
> Im so confused by what SM is trying to do. Their whole phase 2 was only 3 months? How is that possible when it seems they were extending it over and over?
> 
> Do all researchers who are in a clinical trial have to present in such a public way? If this is less than stellar, why present this at a conference, couldnt they just have released the results online? 
> 
> And, why the hell would they be a sponser at the hair congress if they dont assume they can capitalize on it down the road? Where they counting their chickens before they hatched?
> 
> So many of their moves sounded encouraging but to have to restart phase 2 again is a kick in the teeth, and it may yeild no better results than we see now.


 I don't know the answers to all of your questions, and some of them might not really have answers as different companies do different things even when they're seemingly in the same or very similar situations. That being said, I don't think companies have to release results at all and many that do only do so through back channel type methods, such as posting the results on the clinical trials government website or through investor conference calls. So, yes, I think in general companies release information at conferences when they think it's good news. However, they could try to spin half way decent results as being more positive than they are if they were trying to attract more publicity, although they only solicited Forbes for that one piece and most companies looking for money would have publicized the findings a lot more. It seems that a lot of hair loss product companies use some of those old studies of Rogaine and Propecia as the gold standard for how effective their products are (although both seem to more or less not work at all to me, so that may raise some general questions about the validity of medical trials, but that's a somewhat separate question). Are the results they reported significantly better than those old Rogaine and Propecia results? Also, where is the restarting Phase II stuff coming from, is that official or just people conjecturing/rumoring?

----------


## dm90

Don't see why they would restart the phase 2 trial, I haven't read any official statements on that.  The results show a steady, albeit slow, increase in hair and density even after discontinuation.  That's pretty good news to me, I really believe they will go into phase 3 with this.

----------


## Dimoxynil

Maybe theyre so confident that their product is decent that they chose to do a short 3 month trial so as to get in on the market more speedily.

----------


## beetee

https://www.samumed.com/files/2016/A...2016_FINAL.pdf

Here's a link to the official posting of the results. There's a link within this to a slideshow.

----------


## rdawg

Alot of positives to take from this guys, I think people are jumping to conclusions way too fast here, I'll break down why:
Here's the link to the official results release: https://www.samumed.com/files/2016/S...nal_3-1-16.pdf

1. This was a 90 day once-a-day trial, then 45 days of post-treatment assesment, meaning they used the drug for a very short period of time. *After stopping treatment, the hair count continued to increase at month 4-5* (histogen claimed the same thing and after a year had a significant increase) 

2. It shows clear efficacy on hair, and should really see how an increased dose affects the hair over the course of a year

3. We're guarenteed at least a phase IIb here, and I would hope they do once a day for an entire year and see how it is, as well as follow up with the previous group post-treatment after a year and see if they maintained, increased or lost in hair count.

4. The adverse events or side effects were very minor, mostly just tooth ache or muscle ache, nothing major as you can see in the slides above (and only about 5-10% of the subjects in the drug portion of the trial felt the affects).

very very promising stuff, clearly on to something with this drug, I think the hope has to be that it continues to work as more time passes(which appears to be the case).

hopefully they begin Phase IIb or Phase III right away.

----------


## Hemo

They already have a phase IIb going, it ends in April (they're also looking at scalp biopsies in IIb, as opposed to the measurements they took in the first phase II).

----------


## allTheGoodNamesAreTaken

> results are published. they promise 10% in 3 months hahaha
> another charade .. yo all remember the pitch from fin right? yes it was around 40% close to 50%... so it probably makes 1% affect in reality which would not be cosmetically viable anyways.
> so what do you say guys? shall we ask admin to lock this thread...
> 
> I now believe we have talked about SM even more than the scientists working for SM 
> probably they werent even aware that so many people were waiting/talking otherwise they wouldnt have published such funny results


 My non-biologist, non-Samumed employee opinion is worthless but I don't know why this is such a disaster. People are told to try propecia or minoxidil for at least six months or ideally a year before judging it, and even them just causing maintenance with no regrowth can often be considered a success. Hair grows slow and cycles slower. If someone posted on this site that they were noticing a few hairs sprouting after three months from either of those products, people would tell them it was promising progress. And who knows what this could be paired with. So yeah, these results won't blow anyone away but I disagree that they are a reason for full-on pessimism or writing this chemical off. It's one of only a very small number of molecules ever officially shown to grow ANY new hair, compared to a galaxy of failed attempts and useless, baseless snake-oils. So this is something. Not really investing much hope in it but the jury's still out if you ask me. Something safe for long term use that has protective effects on follicles even without regrowth and works on the majority of people would be a good, good thing to happen.

----------


## mayapple

they trialled it for three months - subjects grew NEW hair.  They stopped - it continued to grow NEW hair, in a linear fashion.  I don't know WHAT every one is so upset about already.  IF the subjects in the trial CONTINUE to show increased hair counts in the next few months, then this is HUGE.  It means that it is working months after application.  Lets just wait and see.

----------


## champpy

I thought I read previously but they were restarting phase 2, so if they are not restarting then that's my fault, I'm sorry for rehashing bad info.

I guess there are some positives to take away from this but I think we were all expecting a little bit more. Does anybody remember or know if the molecules Follicum are working with are similar to SM?

----------


## Thinning@30

People keep citing this 40% growth figure from minoxidil.  I'm not sure where that is from, but I think it's worth remembering that the concentration of OTC minoxodil is around 5%, while the SM04554 doses trialed were much lower.  Furthermore, minoxidil doesn't work on everyone, and is known to have sides (heart palpitations, dark circles under the eyes, wrinkles).  What's the point of having a little more hair if you still look way older than you are?  Minoxidil did nothing for me anyway except make my hair look wet and greasy and smell boozy.  And we all know how unflattering the wet look is on thinning hair.

Besides, who knows what SM 04554 might do for low Norwoods?  Perhaps additional tinkering with dosage and vehicle will yield better results.  There was so much hype about the novel mechanism of action with Samumed that I think a lot of us expected NW 6 -> NW 0 conversions or something from the trial, but in retrospect how realistic was that?  Of course, I'm looking for reasons to stay positive here.  I'll be a Norwood 50 billion by the time any new hair loss treatments come to market.

----------


## rdawg

> They already have a phase IIb going, it ends in April (they're also looking at scalp biopsies in IIb, as opposed to the measurements they took in the first phase II).


 Interesting, so it's likely that we see results from the full year wouldn't we very soon? This study started over a year ago i believe. 

It's clear they like the direction of it, so we may actually get a full year update next month! Which would show definitively if this continues to work post-treatment.

----------


## Haircure

> Alot of positives to take from this guys, I think people are jumping to conclusions way too fast here, I'll break down why:
> Here's the link to the official results release: https://www.samumed.com/files/2016/S...nal_3-1-16.pdf
> 
> 1. This was a 90 day once-a-day trial, then 45 days of post-treatment assesment, meaning they used the drug for a very short period of time. *After stopping treatment, the hair count continued to increase at month 4-5* (histogen claimed the same thing and after a year had a significant increase) 
> 
> 2. It shows clear efficacy on hair, and should really see how an increased dose affects the hair over the course of a year
> 
> 3. We're guarenteed at least a phase IIb here, and I would hope they do once a day for an entire year and see how it is, as well as follow up with the previous group post-treatment after a year and see if they maintained, increased or lost in hair count.
> 
> ...


  I think you interpreted the results incorrectly, the 0.15% solution had better results than the 0.25% solution, so a higher dose according to their results does not mean better efficacy. Also their results don't know the number of responders and non responders, so we don't know what it's % effectiveness is. 

I get people want to see this in a positive light, but unless it has a high effectiveness rate for the results they posted and/or the results continue to improve over time, I think we can scratch this off as another failure compared to finasteride/RU/DUT/ and minox.

----------


## beetee

> They already have a phase IIb going, it ends in April (they're also looking at scalp biopsies in IIb, as opposed to the measurements they took in the first phase II).


 Thanks for sharing this. Can you let us know where this information comes from, preferably with a citation or a link? Thanks!

----------


## Hemo

> Interesting, so it's likely that we see results from the full year wouldn't we very soon? This study started over a year ago i believe. 
> 
> It's clear they like the direction of it, so we may actually get a full year update next month! Which would show definitively if this continues to work post-treatment.


 No.  The phase IIb is supplementary and includes different participants, not a continuation (as far as I'm aware).  The initial Phase II already lasted a year - they decided participants would trial the drug for 90 days; that isn't how long the actual clinical trial was (people get recruited at different times, drop out, etc., so it's sort of like a revolving door that's open for 1 year).

----------


## Seuxin

So....we may be get new results after april ?

----------


## beetee

> No.  The phase IIb is supplementary and includes different participants, not a continuation (as far as I'm aware).  The initial Phase II already lasted a year - they decided participants would trial the drug for 90 days; that isn't how long the actual clinical trial was (people get recruited at different times, drop out, etc., so it's sort of like a revolving door that's open for 1 year).


 Can you please share the source for the ongoing IIb information?

----------


## dutchguyhanging

> they trialled it for three months - subjects grew NEW hair.  They stopped - it continued to grow NEW hair, in a linear fashion.  I don't know WHAT every one is so upset about already.  IF the subjects in the trial CONTINUE to show increased hair counts in the next few months, then this is HUGE.  It means that it is working months after application.  Lets just wait and see.


 i see you are obviously newbie and dont even know the pitch from fin. I would strongly advise you to go back and check trial results of fin... i cant here explain numbers to you all.. so yes we are very frustrated and disappointed. case is closed for me. I am not waiting SM anymore

----------


## Hemo

> Can you please share the source for the ongoing IIb information?


 https://clinicaltrials.gov/ct2/show/...samumed&rank=3

it's also mentioned in some articles about them/on their website, but apparently it didn't occur to you to look anywhere.

----------


## dutchguyhanging

> I think you interpreted the results incorrectly, the 0.15% solution had better results than the 0.25% solution, so a higher dose according to their results does not mean better efficacy. Also their results don't know the number of responders and non responders, so we don't know what it's % effectiveness is. 
> 
> I get people want to see this in a positive light, but unless it has a high effectiveness rate for the results they posted and/or the results continue to improve over time, I think we can scratch this off as another failure compared to finasteride/RU/DUT/ and minox.


 oh no of course they know the number of responders and non responders and also one year trademark results. It is just so disappointing that they dont want to publish more than necessary. if it was promising, they would be all over the news guys.
lets be realistic here for a minute ok? image u done the trials and u have seen all nw7 candidates became nw1 in 1 year period. first thing u would do is to call BBC, CNN all mainstream media like, and say that you have found the cure. and ask for financing and get shareholder attention. u dont need to work for the rest of your life once you get it to the market.

just think about it.. yes technology is patented so they dont worry about IP theft or something...

----------


## rdawg

> I think you interpreted the results incorrectly, the 0.15% solution had better results than the 0.25% solution, so a higher dose according to their results does not mean better efficacy. Also their results don't know the number of responders and non responders, so we don't know what it's % effectiveness is. 
> 
> I get people want to see this in a positive light, but unless it has a high effectiveness rate for the results they posted and/or the results continue to improve over time, I think we can scratch this off as another failure compared to finasteride/RU/DUT/ and minox.


 How is a drug that shows clear efficacy *after 3 months* a failure compared to drugs that can take up to a year to show even minimal changes?

You can't scratch this off at all, it's shown initial results, now we just have to see if those results continue. You do make a good point that they didn't show the % that this had an effect on but they may very well do that next month when they show their other trials results.

----------


## Spaniards

Are they going to give up or what? Don´t we have to wait at least until April? 

What do you say? Not very good at chemistry, but it seems some of you are so please enlight me! Thank u guys!

----------


## beetee

> https://clinicaltrials.gov/ct2/show/...samumed&rank=3
> 
> it's also mentioned in some articles about them/on their website, but apparently it didn't occur to you to look anywhere.


 It's not too hard to post a link or two. Thank you for doing so.

----------


## 20legend

We should try to contact Samumed and get some additional info. Maybe they could tell us why there were so optimistic about just 10% increase in hair counts. There might be something more to it. 

Hellouser had spoken to them at the conference. So maybe he might be able to send a short email.

----------


## 20legend

We should try to contact Samumed and get some additional info. Maybe they could tell us why there were so optimistic about just 10% increase in hair counts. There might be something more to it. 

Hellouser had spoken to them at the conference. So maybe he might be able to send a short email.

----------


## Haircure

> How is a drug that shows clear efficacy *after 3 months* a failure compared to drugs that can take up to a year to show even minimal changes?
> 
> You can't scratch this off at all, it's shown initial results, now we just have to see if those results continue. You do make a good point that they didn't show the % that this had an effect on but they may very well do that next month when they show their other trials results.


 You speak of efficacy, which in definition is how effective this drug is in doing what it claims to. The results speak for themselves, a 10% increase in 3 months at *best* is not efficacious compared to the other treatments out there. Look at finasteride and DUT for example, there is a wide spectrum of results for those drugs ranging from no effect (which is very rare) to practically a full recovery of all lost hair, and not to mention maintenance for up to decades of use or more. 

Yes, I agree that 3 months is not a lot of time to see full results, but even in those 3 months there have been numerous cases of people using finasteride/dut and minox which show a much better result. So I stand by what I said earlier, compared to our current treatments, SM04554 is not good enough and imo nowhere close.

----------


## burtandernie

There are a lot of people that use fin and get results 6 months or later. Id say the majority even. So judging how effective fin is after 3 months for everyone in the study isnt really giving a real idea of how good it is. Is SM the same way? No one on earth knows that for a disease no one understands. So is SM good enough? We dont know yet, but 3 month results IMO are pretty meaningless because you cant take that percent and just do math on it or try to predict where it goes. Its not predictable where counts would be in 6-12 months you just have to wait.

----------


## rdawg

> You speak of efficacy, which in definition is how effective this drug is in doing what it claims to. The results speak for themselves, a 10% increase in 3 months at *best* is not efficacious compared to the other treatments out there. Look at finasteride and DUT for example, there is a wide spectrum of results for those drugs ranging from no effect (which is very rare) to practically a full recovery of all lost hair, and not to mention maintenance for up to decades of use or more. 
> 
> Yes, I agree that 3 months is not a lot of time to see full results, but even in those 3 months there have been numerous cases of people using finasteride/dut and minox which show a much better result. So I stand by what I said earlier, compared to our current treatments, SM04554 is not good enough and imo nowhere close.


 
I would love to see some examples of a more than 10% increase in 3 months or less on Fin or DUT I have never read anything on that.

and Im not talking about 1 or 2 extreme cases, show me what the average increase is for FIN and DUT after 3 months, then tell me this stuff is useless.

youre telling me a drug that after 130 days(a little over 4 months) shows a positive trajectory is not good enough? Do you think the drug will only get worse after that, why wouldnt we assume the drug continues to work when *there was a statistical increase 40 days after discontinuation*

I'm actually laughing that you are calling a drug that has a clear positive trajectory and shows growth in it's initial stage 'nowhere close'

If they simply maintained in months 6-12 I would agree, but the statistics show that the opposite should be true and they havent even tested what happens when they continue the dosage.

I would also like to add that you are attacking a drug that is showing *an increase in haircount on late stage NW4+ cases* not early stage cases which would normally show much more response to drugs. 

Has any drug including FIN, DUT or Minoxidil ever shown a statistical effect on late stage balding?

----------


## x4342

> I would love to see some examples of a more than 10% increase in 3 months or less on Fin or DUT I have never read anything on that.
> 
> and Im not talking about 1 or 2 extreme cases, show me what the average increase is for FIN and DUT after 3 months, then tell me this stuff is useless.
> 
> youre telling me a drug that after 130 days(a little over 4 months) shows a positive trajectory is not good enough? Do you think the drug will only get worse after that, why wouldnt we assume the drug continues to work when *there was a statistical increase 40 days after discontinuation*
> 
> I'm actually laughing that you are calling a drug that has a clear positive trajectory and shows growth in it's initial stage 'nowhere close'
> 
> If they simply maintained in months 6-12 I would agree, but the statistics show that the opposite should be true and they havent even tested what happens when they continue the dosage.
> ...


 

Unfortunately that isn't quite true.  Regardless of whether someone is classified as a NW2 or NW7 all that matters is how much hair is present in the given region that is being treated.  It's far easier to get regrowth in a young guy with extremely aggressive hair loss that is is a juvenile hairline/NW7 and has hair present in every region but is diffusing rapidly into a NW7 than it is in a guy with a "slick" mature hairline with tons of hair everywhere except in the far front that is completely lacking in hair.  

   That is why both in both the fin and minox studies they only took data from the crown region.  They did that to put a positive spin on the data.  It's not that fin can't improve the front it's that you only tend to get improvement where there is still plenty of hair.  Once a region is  bald a whole cascade of negative changes begin.  It's the same problem with the histogen studies.  They took their data from regions that had tons of hair and wouldn't have appeared to even show any cosmetic hair loss.  Regrowing hair where there is little or no hair has always been the true challenge.


  Note that Samumed did the same thing.  Their baseline measurements had more than 100 terminal hairs per cm2. That is a *ton* of hair.   In other words they already had more hair than someone typically has *after* a hair transplant.  
People get caught up in hair numbers and percentages but these sorts of comparisons are really apples to oranges.  Going from 100 hairs per cm2 to 150 hairs per cm2 is far, far easier than going from 0 hairs per cm2 to 10 hairs per cm2.  It's a completely different game.  
 The first company to only test their product on slick regions of the scalp will be worth billions because they will truly have solved the problem.


Having said all of that I agree that people are overreacting to the news.  It's easy to spin the data as positive or negative.  If the improvement is continuous and sustainable it could be a be a big deal.  The fact that improvement continued more rapidly from day 90 to day 135 than from day 1 to day 90 could be seen as very positive.  The real "proof" will come from their actions rather than their words.  If they simply initiate another phase 2 trial or go silent the naysayers are right.  If they quickly initiate a phase 3, then things are about to get better.

----------


## mayapple

> You speak of efficacy, which in definition is how effective this drug is in doing what it claims to. The results speak for themselves, a 10% increase in 3 months at *best* is not efficacious compared to the other treatments out there. Look at finasteride and DUT for example, there is a wide spectrum of results for those drugs ranging from no effect (which is very rare) to practically a full recovery of all lost hair, and not to mention maintenance for up to decades of use or more. 
> 
> Yes, I agree that 3 months is not a lot of time to see full results, but even in those 3 months there have been numerous cases of people using finasteride/dut and minox which show a much better result. So I stand by what I said earlier, compared to our current treatments, SM04554 is not good enough and imo nowhere close.


 It's not a really accurate assessment to straight up compare this to finasteride.  I used fin for a year, and I got super super horny and half my hair fell out. Literally.  1) Many people are fed up with fin.  Yes, it works wonders for some, but for a good percentage of the users, it's not efficient or the side effects are too drastic. 2) This COULD be great in complementing other treatments 3) We DO NOT even know it's true efficacy yet.  Fin can take 8, 10, 14 months to start showing cosmetically significant results, if at all.  4) It is showing hair growth after stopping treatment.  10% in three months would be huge if it truly is TERMINAL hair.  if you have say 30,000 hairs in the MPB zones on your head, that's 3,000 hairs in 3 months POTENTIALLY.  I would chop off my right arm right now for 3,000 hairs. haha

----------


## allTheGoodNamesAreTaken

How about this as a reason for cautious optimism: What if the regrowth rate never becomes signifcant for a high percentage of users, but none of them see a decrease in hair? That alone would be a product I'd buy. Far-fetched?

----------


## mayapple

> How about this as a reason for cautious optimism: What if the regrowth rate never becomes signifcant for a high percentage of users, but none of them see a decrease in hair? That alone would be a product I'd buy. Far-fetched?


 Why is that far fetched?  NO decrease in hair is completely maintaining and that is better than anything we have right now.

----------


## SriHanuman

> You speak of efficacy, which in definition is how effective this drug is in doing what it claims to. The results speak for themselves, a 10% increase in 3 months at *best* is not efficacious compared to the other treatments out there. Look at finasteride and DUT for example, there is a wide spectrum of results for those drugs ranging from no effect (which is very rare) to practically a full recovery of all lost hair, and not to mention maintenance for up to decades of use or more. 
> 
> Yes, I agree that 3 months is not a lot of time to see full results, but even in those 3 months there have been numerous cases of people using finasteride/dut and minox which show a much better result. So I stand by what I said earlier, compared to our current treatments, SM04554 is not good enough and imo nowhere close.


 Don't know why you keep reffering in percentages as it doesn't make sense. And it was 10 hairs +/-6 on *average*, after 135 days, on a 1 cm2; 90 days usage.

----------


## mayapple

Someone just needs to crack the code on how to synthesis this drug, or a topical with a similar mechanism of action and we need to test it ourselves.  Either that, or just wait and see if the subjects experience increased hair growth from this study in the next few months.  Either way, without these, this speculation is useless.

----------


## Trouse5858

> Someone just needs to crack the code on how to synthesis this drug, or a topical with a similar mechanism of action and we need to test it ourselves.  Either that, or just wait and see if the subjects experience increased hair growth from this study in the next few months.  Either way, without these, this speculation is useless.


 I wouldn't get my hopes up for the first scenario. People aren't going to be able to just "synthesize" a drug like this just because they understand how it is supposed to work. That's why a pharma company doesn't release in depth details about a drugs' makeup; it's their intellectual property and without it being exclusive, they have no hopes of really being profitable long term. I mean unless there's a full blown genius in bio-chemistry whose currently unemployed and has the time to work through thousands of possible formulas that have been ruled out by a full time team of scientists, that's never going to happen. There's one option and everyone should be quite familiar with it at this point. It's called the waiting game

----------


## Haircure

> I would love to see some examples of a more than 10% increase in 3 months or less on Fin or DUT I have never read anything on that.
> 
> and Im not talking about 1 or 2 extreme cases, show me what the average increase is for FIN and DUT after 3 months, then tell me this stuff is useless.
> 
> youre telling me a drug that after 130 days(a little over 4 months) shows a positive trajectory is not good enough? Do you think the drug will only get worse after that, why wouldnt we assume the drug continues to work when *there was a statistical increase 40 days after discontinuation*
> 
> I'm actually laughing that you are calling a drug that has a clear positive trajectory and shows growth in it's initial stage 'nowhere close'
> 
> If they simply maintained in months 6-12 I would agree, but the statistics show that the opposite should be true and they havent even tested what happens when they continue the dosage.
> ...


 Well first off I figured that since you've been a member longer than I have you'd probably have read the multiple success stories on this very forum or have read at least a few studies published regarding the effectiveness and efficacy of finasteride, Dutasteride, and minoxidil. I guess this is not the case.


I don't have links to those studies saved, but one can easily find then on forums or on google and yes these drugs have been effective on higher norwoods and are much better options that Sm04554. Also these are not extreme cases as you may believe, you can check out this link which shows just how well just Fin and minox work, and keep in mind these don't contain pictures of Dutasteride users which is a more powerful drug

http://www.bernsteinmedical.com/medi...atient-photos/

Like many more educated members regarding hairloss can tell you (ex Swooping) these results are not better than the treatments that we have even though we wish it to be true.

----------


## Haircure

> Don't know why you keep reffering in percentages as it doesn't make sense. And it was 10 hairs +/-6 on *average*, after 135 days, on a 1 cm2; 90 days usage.


 It does make sense because when looking at the hair count increase for the 0.15% it shows an increase of 10 hairs, and so 10/104(which is the initial hair count) = 10% change

----------


## Haircure

> How about this as a reason for cautious optimism: What if the regrowth rate never becomes signifcant for a high percentage of users, but none of them see a decrease in hair? That alone would be a product I'd buy. Far-fetched?


  Well isn't that basically what finasteride does but better? It sucks that Fin, dut and minox is all we have considering what effect they can have on our body, but I've seen this scenario time and time again. A potential new treatment comes out or is in clinical trials and some people get over-hyped (often aggressively) then after a few months or even a year people realize it wasn't what they thought it was even though they read the reports or the results, but it was their hope and optimism that led them to want it to be the cure.

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## allTheGoodNamesAreTaken

> Well isn't that basically what finasteride does but better? It sucks that Fin, dut and minox is all we have considering what effect they can have on our body, but I've seen this scenario time and time again. A potential new treatment comes out or is in clinical trials and some people get over-hyped (often aggressively) then after a few months or even a year people realize it wasn't what they thought it was even though they read the reports or the results, but it was their hope and optimism that led them to want it to be the cure.


 The difference would be not messing around with your hormones, which stops many from ever bothering with fun. Plus fin just doesn't work for some people. So an another option would be useful.

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## dutchguyhanging

> The difference would be not messing around with your hormones, which stops many from ever bothering with fun. Plus fin just doesn't work for some people. So an another option would be useful.


 you guys never learn... i mean never ever... first of what do you know if this treatment has no side effects? maybe they have even worse?

Secondly, 10% hair increase is even worse than what fin has pitched in trails. They were around 13%...
and some people, actually alot of us saying fin gives us no growth... how do you expect SM will give you any growth??
Third,  if you can not reserve balding then u r not stopping it either. So it is like ageing, either you reverse it or you age.. slowing down would not work. Well fin does that already even though they claim it gives regrowth.

In sum, these numbers are no good/better than fin. in other words total waste of time and money spent on this product.It is better to stop investing at this point and let it go

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## dm90

> you guys never learn... i mean never ever... first of what do you know if this treatment has no side effects? maybe they have even worse?
> 
> Secondly, 10% hair increase is even worse than what fin has pitched in trails. They were around 13%...
> and some people, actually alot of us saying fin gives us no growth... how do you expect SM will give you any growth??
> Third,  if you can not reserve balding then u r not stopping it either. So it is like ageing, either you reverse it or you age.. slowing down would not work. Well fin does that already even though they claim it gives regrowth.
> 
> In sum, these numbers are no good/better than fin. in other words total waste of time and money spent on this product.It is better to stop investing at this point and let it go


 I'm fairy certain they released plenty of statements about the tolerability of the drug, so your first point about side effects is just not necessary.  Did you mean reverse or reserve?   Because if that's the case then thats absolutely false.  Ive been a NW2 for nearly 7 years on fin, id definitely call that stopping hairloss, and no I didnt get any regrowth.  The drug still holds promise, there is a known link between DHT and WNT inhibition.  Reducing DHT and upregulating the pathway could be huge in regards to efficiency.  Thats why its important for them to continue the trials, which it looks like that are.  We need to see what this drug can do in conjunction with fin.

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## dutchguyhanging

> I'm fairy certain they released plenty of statements about the tolerability of the drug, so your first point about side effects is just not necessary.  Did you mean reverse or reserve?   Because if that's the case then thats absolutely false.  Ive been a NW2 for nearly 7 years on fin, id definitely call that stopping hairloss, and no I didnt get any regrowth.  The drug still holds promise, there is a known link between DHT and WNT inhibition.  Reducing DHT and upregulating the pathway could be huge in regards to efficiency.  Thats why its important for them to continue the trials, which it looks like that are.  We need to see what this drug can do in conjunction with fin.


 everyone case is different. I agree 100%. but it wont say anything about u becoming NW5 in next 3 years... Fin can not guarantee you that.. neither SM...

so yes one thing is clear, SM didnt live up to its expectations.. no cure... It means SM isnt significantly better product than fin. another mediocre treatment or finding...

Can you risk switching to SM? even tho you know they gives no regrowth.. Of course you wont.. SM results are lower than fin and what if it makes your hair worse? I hear you saying side effects.. well no one knows yet for SM. maybe it is more dangerous in long term... So not worth switching overall..

I firmly believe that fin is the worst thing happened to hair loss community. Mediocrity is the worst kind of all...

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## allTheGoodNamesAreTaken

> you guys never learn... i mean never ever... first of what do you know if this treatment has no side effects? maybe they have even worse?


 I don't know if it has any side effects, I've so far not heard of any but it's too early to judge that, just like it's too early to judge its effectiveness. What I do know is that it isn't about inhibiting the enzyme responsible for DHT, it's a different approach altogether. So there's good reason to hope it won't give the sexual or other side-effects that scare so many people off finasteride.




> Secondly, 10% hair increase is even worse than what fin has pitched in trails. They were around 13%...


 First of all, assuming 100% = 100 hairs per square cm so 10 hairs per cm^2 = 10%, it cannot yet be said to be better or worse than fin if SM gets 10 +/- 6 %. That means the true answer somewhere between 4% and 16%, and fin's 13% falls within that range. Anyway, if someone takes fin for just 3 months and sees any sort of positive change they're rightly told they should be happy with progress so far and to expect better results if they stick at it. And even if this never gives significant regrowth, it might well still turn out to reliably prevent further loss - fin doesn't in 100% of cases so an alternative would be great. 

That's not a ridiculous, wildly optimistic thing to hope for from something that has actually already been shown to regrow some hair. Something countless treatments and products have promised and failed to do. Even at this early stage it's about as good as the handful of things that have ever been shown to do make any difference.




> and some people, actually alot of us saying fin gives us no growth... how do you expect SM will give you any growth??


 Well they've already reported that it does cause some growth... and it works in a different way to fin too, so there's no grounds for comparison.




> Third,  if you can not reserve balding then u r not stopping it either.


 This just isn't true. It's not hard to imagine a situation where you're interrupting processes that further degrade follicles without rejuvenating the ones that have degraded far enough to stop working. Plenty of people see a halt in hair loss for years with no regrowth from finasteride too.




> So it is like ageing, either you reverse it or you age.. slowing down would not work.


 See above.




> In sum, these numbers are no good/better than fin. in other words total waste of time and money spent on this product.It is better to stop investing at this point and let it go


 All in all, an unjustified, premature conclusion. It's too early to write this one off as a worthwhile product.

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## dm90

1

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## BoSox

Seems as though Samumed is getting more attention..

http://metro.co.uk/2016/03/07/good-n...trial-5737944/

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## dutchguyhanging

> Seems as though Samumed is getting more attention..
> 
> http://metro.co.uk/2016/03/07/good-n...trial-5737944/


 like I said above, all in all, Mediocrity is the worst....

it may or may not be better than fin. one thing sure it wont be significantly better treatment than fin. just another option on shelf.

so again we will be talking on and on about same problems after SM launched as well. so my question to you, why spent time on this already? its over, no cure...

i like the comment from hairloss2020.. it is no cure lets move on the next...

why do you care if it is + or - 1% hair more or not? u see the results and u know fin results. they are statistically not different. then why are u convincing yourself that this could be better?

u made ur trial and you see you made Nissan, and you are saying no in the next trial Nissan may turn to Mercedes... you get me?

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## amunt

Just drink olive oil (Extra Virgin Olive Oil) do the same job as SM04554 . The magic start from Oleuropein

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## champpy

I remember in an early report from samumed they claimed that SM was "creating new follicles"
Did anyone hear anything further on this claim from the March 5th results? 
Id love to know if they concluded if they were actually growing NEW follicles or just reviving old ones. I tend to believe the growth is coming from dormant follicles, not new ones

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## Seuxin

Olive oil do the same job os SM ??? Are you fully retarded ?????

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## bboyforever

> it may or may not be better than fin. one thing sure it wont be significantly better treatment than fin. just another option on shelf.


 The only thing we can be cure of is that we can't be sure of anything yet. As I said before it all depends on how these results scale over a treatment period of longer than 3 months. We know the limits of Fin and Minox, we don't know really what to expect here.

Again, you've got to keep in mind how far down the cascade we are here. This is new ground and I think we stand to learn a lot regardless of how successful this is as a stand alone treatment. I'm really interested to see what the results of the biopsies are going to be.

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## rdawg

It's ridiculous to get too positive or negative here, it was a 4 month trial, which by hairloss standards is absolutely miniature.

It had a positive(albeit small) affect on hairloss and seemed to have a linear progression after the medication was stopped.

However it wasn't very significant, we dont know if that progress will continue nor do we know if it would 100% stop.

saying this should be scrapped is as silly as saying it's an amazing product, neither of these statements have been made factually true.

I am however still very intrigued, and it did show small early positive results, so I look forward to the next trial.

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## gagost

error url

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## gagost

error url

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## gagost

https://www.samumed.com/medium/image...i_35/view.aspx

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## BoSox

> https://www.samumed.com/medium/image...i_35/view.aspx


 Best news I heard all year.

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## Notgivingup2

What is this from October?  I thought these guys released pretty underwhelming results back in march or something?

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## beetee

Great post! Thanks for finding and putting up. The devil is always in the details with these things and we obviously have to wait to get more info on the amount of regrowth etc but I think any way you slice it this is positive and encouraging news, especially compared to what we normally get.

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## allTheGoodNamesAreTaken

The plot thickens... but will our hair? Stay tuned.

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## k9gatton

If I remember this correctly, when they had the right dose people had great results. Too much made a bad outcome.

The hair loss community needs something new, to get the wheel rolling again.

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## k9gatton

If I remember this correctly, when they had the right dose people had great results. Too much made a bad outcome.

The hair loss community needs something new, to get the wheel rolling again.

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## BoSox

It's been so long now I'm starting to not care any more. They should already have something out by now. This is such bs.

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## k9gatton

It's crazy. Instead of focusing on new treatments in the US, nothing has come out.

Nothing in the pipeline. It's like the future of treatments is gone.

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## karxxx

> It's crazy. Instead of focusing on new treatments in the US, nothing has come out.
> 
> Nothing in the pipeline. It's like the future of treatments is gone.


 
What is worse
Do all treatments die?
Histogen, sheido, brotzu

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## karxxx

Samumed dead?
Your future treatments are dead?

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## KarlS

they say on their website Wnt causes cancer, why is it ok to put it on our heads?

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## gagost

Samumed Presented Data on Increases in Hair Follicles Observed in Its Phase 2 Biopsy Study for a Potential Treatment of Androgenetic Alopecia (AGA) at Annual Meeting of the American Academy of Dermatology (AAD)

https://www.samumed.com/medium/image...t_63/view.aspx

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## gagost

double post

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## BoSox

> Samumed Presented Data on Increases in Hair Follicles Observed in Its Phase 2 Biopsy Study for a Potential Treatment of Androgenetic Alopecia (AGA) at Annual Meeting of the American Academy of Dermatology (AAD)
> 
> https://www.samumed.com/medium/image...t_63/view.aspx


 Great news!

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## Notgivingup2

Soooooooo... we're cured?

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## beetee

> Samumed Presented Data on Increases in Hair Follicles Observed in Its Phase 2 Biopsy Study for a Potential Treatment of Androgenetic Alopecia (AGA) at Annual Meeting of the American Academy of Dermatology (AAD)
> 
> https://www.samumed.com/medium/image...t_63/view.aspx


 Seems like it could be good news. But don't clinical studies of minoxidil show "statistically significant" regrowth too (and I don't think of minoxidil as a legitimate treatment, let alone a cure)?

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## lurker1

> Seems like it could be good news. But don't clinical studies of minoxidil show "statistically significant" regrowth too (and I don't think of minoxidil as a legitimate treatment, let alone a cure)?


 "Patients who took the drug seemed to see the number of hairs in a one square centimeter area of their scalp increase, while those in the control group lost hair. In the control group, hair count dropped from 114 hairs per square centimeter to 111.5. In the 0.15% group, hair count increased from 104.9 to 115. In the 0.25% group, hair count increased from 110.8 to 118.5."

https://www.forbes.com/sites/matthew.../#58a4a8492a44

Keep in mind, the results are just from 90 days of use, and hair counts were performed at baseline, on day 90 and day 135. There was continued improvement even 45 days after the treatment was stopped.

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## FearTheLoss

Anyone know what their next step is? If they are planning to head into phase three next or what?

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## allTheGoodNamesAreTaken

What I found interesting is this:
https://www.samumed.com/medium/image...t_63/view.aspx

"
- SM04554 may be the first treatment leading to follicular neogenesis

- Both treatment groups exhibited statistically significantly higher total follicle counts compared to vehicle  
"

It's notable because if I'm not mistaken, Histogen's Gail Naughton talks in one of her interviews about it being augmented a lot by something that could cause new follicles to start forming. I think Follica was suggested at the time. But this could be useful.

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## jay woo

The link below contains links to abstracts and posters from recent conferences.
https://www.samumed.com/publications/default.aspx

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## Gon

should we open the champagne bottles ?

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## BoSox

What for?

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## BoSox

> should we open the champagne bottles ?


 What for?

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## Gon

> What for?


 for this 



> "
> - SM04554 may be the first treatment leading to follicular neogenesis
> 
> - Both treatment groups exhibited statistically significantly higher total follicle counts compared to vehicle  
> "

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## BoSox

> for this


 Ohhh, they even saw growth when the treatment was stopped. I hope this doesn't just grow "some of our lost hair". Anybody know when they plan on commercializing this?

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## BoSox

> for this


 Ohhh, they even saw growth when the treatment was stopped. I hope this doesn't just grow "some of our lost hair". Anybody know when they plan on commercializing this?


SORRY FOR THE DOUBLE POSTS. MY INTERNET KEEPS LAGGING.

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## WanderingOracle

> - SM04554 may be the first treatment leading to follicular neogenesis


 Is it true neogenesis, or just an extended time before it fully wears off? Dut sticks around in your system for months after use.

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## Vincent21

A resource that will help in writing https://rocketpaper.net/argumentativ...n-writing-help

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