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

[Pentarou]

If this treatment could be given twice a year without comprimising health (so no adverse effect on hemoglobine) AND the treatable size of the scalp would be big enough (again without effecting hemoglobine), then yeah, this could be something. But even then, visiting their clinic twice a year, for pretty marginal results, would still suck. And would indeed also be quite a drain of money.

Imagine if it was the cost of a modest hair transplant - but yearly. It'd be unaffordable for all but Hollywood A-listers and other assorted multimillionaires.

[TravisB]

So Histogen is basically dead...

Next stop - Aderans, Replicel, CB 03-01

[BoSox]

I'm glad I read the results before I saw all your comments. You guys are soo negative it's embarrassing. Histogen is moving forward, and that's all that matters.

[Thinning87]

That's what they said but to me it seems just a part of the negotiations strategy. If they'd admit they were broke, finding an investor would even be more difficult (since its power over Histogen would be bigger).

God are you serious? Why don't you just look at how much they raised and do an estimate of how much they must have spent. No way they ran out of money. Stop looking for reasons to complain.

I'm glad I read the results before I saw all your comments. You guys are soo negative it's embarrassing. Histogen is moving forward, and that's all that matters.

Yeah, unbelievable comments. No one had ever promised a permanent reversion of hair loss. HSC is clearly a thickness and count booster, with benefits obviously decaying over time.

The real question will be wether it'll be possible to continuously take shots to get some good results in combination with a good HT and other stuff.

But don't forget phase 2B will be about optimizing the product. Hopefully they can do better and we will have an upper limit for how much of the substance we can have us injected with.

[Arashi]

God are you serious? Why don't you just look at how much they raised and do an estimate of how much they must have spent. No way they ran out of money. Stop looking for reasons to complain.

Chill out dude, don't take it personal. I'm just basing my comment on what I've read here on this forum, on how Histogen has supposedly communicated towards several people that they're currently looking for an investor. And with those really disappointing results that's going to be quite difficult in my opinion. No way I'd invest a dime into this company with those results.

[Thinning87]

Hey guys,

Histogen has finally published the results of their 12 month Phase I/IIa results. Here's the link:

http://www.histogen.com/downloads/ii..._hsc_final.pdf

There's a lot of information which is provided and requires extensive discussion.

1) Duration of Efficacy: Although the patients remained above baseline at the 48 week follow-up, the effects started to wear off by that point: % Change from baseline: 19% (Week 12) compared to 12% (Week 36). This means that patients will need booster shots at least ONCE A YEAR.

Also, isn't it odd how they haven't provided data on % change from baseline for the 48th week even though they did measure it! (Food for thought)

2) Total Hair count in the Temporal Region (temples) increased only by 2.5% at the 48 week follow-up.

3) Therapeutic Window: They found a direct relationship between dose and possible toxicity (Haemoglobin count). Therefore, only so many mL of HSC can be injected at a given session. Otherwise, your Haemoglobin levels may drop and lead to anaemia and other related conditions. This is very important, as it means you cannot get Histogen injected all over your scalp in a single session... HSC will be simply used in your most problematic areas to give you that extra boost in hair density.

4) Safety: using only 8 shots of HSC lead to no abnormal parameters in trial subjects. Furthermore, all reported side effects were mild and transient, which is a big plus.

1 and 2) The benefits decay overtime, we all knew that....

3 and 4) We don't know yet how often and how much can be injected. Assuming your deduction of an upper limit is correct, I wouldn't conclude the maximum level than can be injected is insufficient for significant growth and results. I think this is where phase 2B comes in, but we don't know that this is a major problem. They could figure out strategies to inject larger amounts in such ways not to increase significantly the risk of dangerous side effects.

[Arashi]

Yeah, unbelievable comments. No one had ever promised a permanent reversion of hair loss. HSC is clearly a thickness and count booster, with benefits obviously decaying over time.

Well at least to me it's new that the effects start to wear of within 24 weeks already. Maybe even much sooner. And that HSC decreases hemoglobin production. And that it thus seems like you'll need at least 2 shots/year but that would risk hemoglobin levels (and even if it didn't, then it would still be a huge hassle to visit them twice a year for injections for only a marginal improvement).

[Thinning87]

Chill out dude, don't take it personal. I'm just basing my comment on what I've read here on this forum, on how Histogen has supposedly communicated towards several people that they're currently looking for an investor. And with those really disappointing results that's going to be quite difficult in my opinion. No way I'd invest a dime into this company with those results.

I'm very calm.

Also, you are the perfect example of why need the forum to be reorganized in a way so that official information is stored and quickly accessible.

You deducted Histogen ran out of money. That is not true; Dr. Naughton released an interview with the MIT Enterprise Forum of San Diego back in Octoer/November stating they were looking for a partner with considerable financial and marketing weight to accompany them into their later stages of product development, and then eventually rely on their marketing power to launch the product the right way.

This is what Replicel is also doing, and what a lot of biotechs have been doing increasingly in recent years because of how tough it is to fund this type of research. As you may have noticed in fact, additional funding to Replicel will come only if they meet certain milestones...

Apparently some of us have received emails from someone at Histogen that any additional funds would be welcome. This is what you have read and this is not equivalent to saying they have no money.

[Arashi]

I'm very calm.

Also, you are the perfect example of why need the forum to be reorganized in a way so that official information is stored and quickly accessible.

You deducted Histogen ran out of money. That is not true; Dr. Naughton released an interview with the MIT Enterprise Forum of San Diego back in Octoer/November stating they were looking for a partner with considerable financial and marketing weight to accompany them into their later stages of product development, and then eventually rely on their marketing power to launch the product the right way.

This is what Replicel is also doing, and what a lot of biotechs have been doing increasingly in recent years because of how tough it is to fund this type of research. As you may have noticed in fact, additional funding to Replicel will come only if they meet certain milestones...

Apparently some of us have received emails from someone at Histogen that any additional funds would be welcome. This is what you have read and this is not equivalent to saying they have no money.

Ok. But either way, they're looking for an investor. In my opinion something that won't be easy with these results. We'll see about that.

[Thinning87]

Well at least to me it's new that the effects start to wear of within 24 weeks already.

Well no one ever promised your hair would be back to where it was on its own. I bet if you had read and informed yourself you would have noticed that the fact that benefits decay overtime. Let me tell you now: this is like botox in the sense that it's an injection of some stuff that makes you look better for some time because it adds longevity to your skin, but it doesn't "reprogram" the behavior of that skin telling it to go back to what it was before.

Maybe even much sooner. And that HSC decreases hemoglobin production. And that it thus seems like you'll need at least 2 shots/year but that would risk hemoglobin levels (and even if it didn't, then it would still be a huge hassle to visit them twice a year for injections for only a marginal improvement).

This is just speculation from our good Desmond. That there would have been some upper bound in terms of how many shots you can take in a given amount of time was a given, we just need to find out in phase 2B what that upper bound is so we can weigh in the safe growth benefits with the expense and frequency of expenditure for a treatment.

What I'm telling you guys and Desmond is that they don't know that upper bound yet, and that's what they'll work on in phase 2B.