Histogen's FINAL Phase I/IIa Results (2013)

[greatjob!]

VC's are some of the dumbest and most arrogant people you will ever meet. .

This is may be the most accurate statement every written on these forums. Show me the biggest narcissistic sadist douchebag you can find, and I'll show you a venture capitalist.

[Thinning87]

Hey guys,

I came across an article today regarding drug development and it was so spot on regarding the current situation of Histogen that I thought I should post it here:

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Challenges of Biotech

The challenges facing the biotech firms in 2013 are acute. Once viewed as a source of fresh innovation, many biotech companies with new molecules or technology platforms are struggling to access capital, and are finding it increasingly difficult to find large pharmaceutical partners willing to take
over promising products in early-phase development.

Indeed, a 2010 survey by Lazard indicated that 89% of Big Pharma execs say filling late-stage pipeline is one of the top driving forces in pharma-biotech consolidation, while only 32% chose filling early-stage pipeline as one of the top three factors.

In the wake of the global financial crises, biotech companies are caught between a risk-averse pharmaceutical industry unwilling to license products in early development, and skittish financial markets where access to capital has become increasingly challenging.

As a result, many biotech firms find themselves in the discouraging position of having met their strategic objectives of progressing a bio-asset to a pre-determined end point of pre-clinical or early clinical development, but unable to find a partner willing to complete clinical development and commercialize the product. This poses a formidable problem for the biotech industry in three important ways:

• The most expensive part of clinical development is Phase III, requiring large studies with patients enrolled over a large geographic spread. On average, for every new molecular entity (NME) that reaches registration, 90% or more of the R&D costs occur in Phases II and III. Most biotech companies do not have the financial capital to progress a compound through late stage development.
  
• The skills needed for research versus clinical development are very different. Successful biotech companies have excellent discovery platforms and scientists, but generally lack the knowledge and skills needed for clinical development and the commercial acumen to build value into their late phase studies.
  
  
• While research and discovery are a physically concentrated activity requiring limited, albeit specialized, infrastructure, clinical development is a much more expansive global process. Therefore, many biotech companies often find the challenges of product development nearly insurmountable – the need for cross-functional teams representing clinical pharmacology, medical, regulatory, clinical operations and drug safety, plus strategic marketing input and market access strategies dispersed across geographic regions as diverse as the US, Europe, Japan and China.

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Here's the link to the article:

http://www.quintiles.com/assets/0/111/118/233/1336/cb9d88e2-ff07-4316-8784-93d75b064b9b.pdf

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So, even though Histogen has a working formulation, they are facing significant challenges to find a partner to carry out the remaining trials!

So what do you guys think we could do to help them out?

Should we be writing petitions to Pfizer, Merck and other big Pharma to provide funding to Histogen!

We certainly have a strong voice! There are a lot of MPB sufferers out there and thousands alone on this single forum! Let's get the ball rolling or we'll be waiting for a very long time for Phase 2b to start!

This has been the trend for a few years now and it's not new stuff at all.

However, this has been true of the industry as a whole, but it doesn't have to be applied to every single company. I directly know top managers in two Southern California biotech start ups who have been able to avoid these problems.

And by the way, this trend seems to be inverting as some big pharma's are investing in new companies in association with local VC's who provide guidance and expertise. Big pharma's have been taking a little bit more risk recently, which seems to be a result of the fact that they don't have much new stuff in development.

Ultimately, I would keep in mind that this is not another drug to lose weight. We are talking about products that would do a great deal against hair loss, which should be looked at differently from the biotech industry as sa whole. I say Histogen has multiple potential candidate partners and they are negotiating for the best deal they can get.

And by the way I don't understand why everyone is so negative here, we have had an overdose of good news in the past weeks. I think simply there is nothing to talk about for some time and the frustration simply gets funneled in here in the form of pessimism.

Keep positive guys we are headed towards a hairy future! It's just not going to happen in the short run unfortunately... I got my money on Follica.

[yeahyeahyeah]

Guys, when I wrote the initial post, my aim was NOT to write off Histogen. I was simply highlighting the points that were NOT known up until the recent announcement.

I think it's important to clear up what these results showed:

1) Histogen was ABLE to INCREASE Terminal hair count by up to 40%! That is VERY GOOD by all of today's standards.

2) The vellus hair count dropped significantly after 24 weeks, because obviously they had turned terminal.

3) The total hair count however, did NOT change all that much in the temporal area (temples). Total hair count in other areas of treatment were NOT provided and hence anything we say about it will be speculation.

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What these 3 points highlight is that Histogen RESCUES DYING FOLLICLES by turning vellus hairs into terminal. It puts these hairs into a long-term ANAGEN phase...hence, its overall mechanism of action is very similar to Minoxidil!

However, Histogen has a much longer biological half-life as patients remained above baseline for 48 weeks after 2 applications...whereas, the effects of Minoxidil last 12 hours, thereby requiring TWICE DAILY application!

So in comparison to Minoxidil, it provided far greater potency in terms of increasing the terminal hair count.
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4) Follicular neogenesis (brand new follicles) did NOT occur! Or if it did, it was not statistically significant (i.e. 2.5%)...Hence, it is fair to say it will thicken up recently thinning areas BUT will NOT do much on slick bald areas.

This was clearly evident in the Ziering photos that was published in October 2012...It had simply thickened up the thinning areas in the male patients

5) The potential for toxicity is there...BUT
The BUT makes all the difference.... Histogen still does NOT know the safe dose range! So far, they have injected up to 40 injections per session without any signs of toxicity (Zieiring trial). 40 shots would approximately cover a 2.5 cm2 area!

Their Phase IIb trial which is the "Dose-range finding" trial will clarify this critical question! If we can get 100 injections per session without the risk of toxicity then we will be able to maintain our hairline for a very long time to come!

CB-03-01 will become available at around the same time to take care of the crown...

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Finally, I'd like to say that losing your hair is very traumatic for most. We are all emotional and we all would like this to end! So we are hoping for a silver bullet that will fix everything! Unfortunately, as we all have figured out, there is no such thing...In the future, we will most probably need a combination of treatments to combat AGA!

What's important is these tools are becoming available...But non of them are perfect and they all will have pros and cons...

Our aim should be to study these therapies thoroughly and get a full picture of what to expect from these treatments rather than what we would like it to do...

My aim was to help those with no medical background to fully understand what was being presented by Histogen without bias! No one likes to be the carrier of bad news and many are upset with me for highlighting the possible limitations of Histogen! BUT like I promised, I will NOT be putting any of you guys at risk of a possible harm by being overly optimistic and blinded by false hope! I will never forgive myself if I missed a critical piece of information and put some of you guys in the harms way!

Hope that makes ppl a bit more happy!


Regards,

- Semi-optimistic Des

+1

I have been saying this forever - that histogen is basically minox on steroids that won't benefit NW7s.

The likelihood is, this will be used in conjunction with a HT. And is a great treatment for those have are NW1 - NW4s as we can:

1) say bye bye to propecia and it sides
2) bye bye to minox

and

3) Have much more aggressive HTs, without worrying about losing hair behind it, due to being able to get a top up.

The only thing stopping Dr's from being aggressive with their HT is hairloss.

Note:
If you are a NW2 in your mid-to late twenties, without crown thinning, chances are you wont lose your hair anytime soon. Tend to find the high norwoods lose their hair earlier.

Stay off the forums.

[yeahyeahyeah]

Pretty much it. You can only put your life on hold for so long. Focus on improving yourself and making the most of what you have.

Yes, hairloss sucks, especially at a young age, but there's very little you can do about it right now. It's tough accepting something when you know you're not living up to your full potential. But when there's no other options, you have to move on.

I still think it's worth keeping up with the forums periodically to read about the latest developments. I'm sure the next couple of years will bring alot more positive information than the last year or so. But obviously you have to keep it from being compulsive.

Great post.

Being a NW2, I have accepted that I am one, despite hating it. But glad my hairloss is slow. I have like you said stayed off the forums. Only to check back periodically.

I am finding the time is going by A LOT quicker, whereas when I was checking this place every day, it felt like things were going at snails place, plus my obssession with hairloss increased.

[john2399]

+1

I have been saying this forever - that histogen is basically minox on steroids that won't benefit NW7s.

The likelihood is, this will be used in conjunction with a HT. And is a great treatment for those have are NW1 - NW4s as we can:

1) say bye bye to propecia and it sides
2) bye bye to minox

and

3) Have much more aggressive HTs, without worrying about losing hair behind it, due to being able to get a top up.

The only thing stopping Dr's from being aggressive with their HT is hairloss.

Note:
If you are a NW2 in your mid-to late twenties, without crown thinning, chances are you wont lose your hair anytime soon. Tend to find the high norwoods lose their hair earlier.

Stay off the forums.

We still are prob going to need propecia still so i wouldnt go that far. Def bye bye to minox tho.

[yeahyeahyeah]

We still are prob going to need propecia still so i wouldnt go that far. Def bye bye to minox tho.

Why would we need propecia, when this thickens up thinning hair, unlike minox - it is not cosmetic either - it is reversing the damage DHT has caused.

Just keep getting it topped up every 24 weeks.

[Kiwi]

So, even though Histogen has a working formulation, they are facing significant challenges to find a partner to carry out the remaining trials!

So what do you guys think we could do to help them out?

Should we be writing petitions to Pfizer, Merck and other big Pharma to provide funding to Histogen!

We certainly have a strong voice! There are a lot of MPB sufferers out there and thousands alone on this single forum! Let's get the ball rolling or we'll be waiting for a very long time for Phase 2b to start!

How do you know that they are facing challenges for carrying out the remaining trials? I've not read anything official from Histogen to that effect :/

[Kiwi]

I think it's important to clear up what these results showed:

*) The total hair count however, did NOT change all that much in the temporal area (temples). Total hair count in other areas of treatment were NOT provided and hence anything we say about it will be speculation.

*) The potential for toxicity is there...BUT
The BUT makes all the difference.... Histogen still does NOT know the safe dose range! So far, they have injected up to 40 injections per session without any signs of toxicity (Zieiring trial). 40 shots would approximately cover a 2.5 cm2 area!

Are you so sure? Histogen explicitly said that HSC works on typically hard to treat areas such as your temples.

My understanding is that the only thing HSC is toxic to are cancer cells!!!

Also Desmond - do you think that the next phase is the riskiest phase since they are trying to increase potency? Also you do realise that IF they do manage to increase potency and prove safety at the same time then we are all in luck!!!

[k3nk3n]

Sorry guys but a little off topic here but has anyone contacted Histogen or Dr.Gail for the pass few days? I have been emailing with Dr.Gail for a couple of weeks about when will the next sponsored trail will begin. She usually relies in a day or 2, but now it's been a week and still no words from her.

Has anyone been in contact with her? Or maybe she doesnt want to answer my questions lol

[FearTheLoss]

Sorry guys but a little off topic here but has anyone contacted Histogen or Dr.Gail for the pass few days? I have been emailing with Dr.Gail for a couple of weeks about when will the next sponsored trail will begin. She usually relies in a day or 2, but now it's been a week and still no words from her.

Has anyone been in contact with her? Or maybe she doesnt want to answer my questions lol

My guess is they don't want to release any information to the public right now because every time they do people overreact and make wild assumptions. We get proof of a treatment that is better than minox and fin in their last results (with no loss of the dick, mind or puffy face) ...and people call it a fail????? WTF

[rdawg]

My guess is they don't want to release any information to the public right now because every time they do people overreact and make wild assumptions. We get proof of a treatment that is better than minox and fin in their last results (with no loss of the dick, mind or puffy face) ...and people call it a fail????? WTF

lmao agreed, this stuff works.

IMO this and Bimatoprost are the first generation of products that will actually give us noticeable gains but not fullout cures.

I think Follica and the whole wounding thing will the be next generation of products, to actually get us near NW0 status.

anything that works better than fin or min is a success in my eyes, the only dissapointing part is how far away this stuff is!(at least 2-3 years)

[FearTheLoss]

lmao agreed, this stuff works.

IMO this and Bimatoprost are the first generation of products that will actually give us noticeable gains but not fullout cures.

I think Follica and the whole wounding thing will the be next generation of products, to actually get us near NW0 status.

anything that works better than fin or min is a success in my eyes, the only dissapointing part is how far away this stuff is!(at least 2-3 years)

I agree, hopefully it is closer to 2 years haha...

but who knows what aderans has up their sleeves as well. They are supposed to be releasing a product in 2014...but they leave us in the dark.

I have high hopes for Follica, but I think replicel will be the cure..in 6-8 years.

[ar50]

man thats to long.

I really hope they invent some kind of Limitless drug and some of these scientists uses it and finds the cure in 1 week and we all will be happy.

[rdawg]

man thats to long.

I really hope they invent some kind of Limitless drug and some of these scientists uses it and finds the cure in 1 week and we all will be happy.

short term(as in like a year or so) we could get topical finasteride so there's that.

There's also ALOT going on in terms of grey market products that inhibit PGD2, just gotta find the right one, which will only take a few months hopefully.

we also have the chance of what desmond was talking about, where they create human organs for testing which would shorten the FDA process alot! but that's probably years away too haha.

[FearTheLoss]

short term(as in like a year or so) we could get topical finasteride so there's that.

There's also ALOT going on in terms of grey market products that inhibit PGD2, just gotta find the right one, which will only take a few months hopefully.

we also have the chance of what desmond was talking about, where they create human organs for testing which would shorten the FDA process alot! but that's probably years away too haha.

topical finasteride reduced serum DHT close to the same as oral...people who get sides from oral fin will still get sides from topical...but topical will be more effective. So topical is only good if you can handle fin....sucks, i know.