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

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.

Does it matter that the patients were 40+ and thats why the effects wore off ?

I doubt it...if that was the case, I'm more than certain they'd be highlighting it! Something along the lines of those in the younger age group kept their new density for the entire 48 week trial!

I can't help but feel a little deflated at this news, to be honest. I still have great hope for Histogen but, well... :\

*scrambles for finasteride*

Desmond

Where did you get the figure of 2.5% from, for the temples?

^^^ yeah 2.5%??

Guys I also didnt know anything about the toxicity issues - where is that located on the poster linked by Desmond?

Look at the blue bar presented under the heading Temporal Recession Region

Quote:

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Originally Posted by UK_

^^^ yeah 2.5%??

Guys I also didnt know anything about the toxicity issues - where is that located on the poster linked by Desmond?

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Uk look under the heading: "FST bioactivity in hsc"

Welp...go team replicel

Bloody hell, if it wears out after only a year or so, it'd better be (relatively) dirt cheap, like a lot less than a hair transplant. I couldn't see the point otherwise.

Jesus Christ man, this is so ****ing bad.

Quote:

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Originally Posted by Desmond84

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

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Should I analyze subject's S2011 48-weeks result ...
http://www2.picturepush.com/photo/a/...C-48-weeks.jpg

... as I did it with the other subjects?

http://www.baldtruthtalk.com/showthread.php?t=10051

In advance: I can only see a completely normal circulating (anagen-catagen-telogen) test area.
There is absolutely nothing unusual to see.

I can't see any difference between the baseline and 48 week pictures

Same ere lol.

WAIT A MINUTE!!!

...oh no thats just a shedded hair on my screen.

Quote:

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Originally Posted by UK_

Jesus Christ man, this is so ****ing bad.

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And we thought the Replicel results last May were bad... This is awful. Beginning to think this will be canned long before it becomes a marketable product.

The results are not that bad! 19% increase in hair density is pretty decent. The question is what role does hsc play in terms of management of MPB. I suppose what these results show is that it will be an add-on therapy rather than a stand-alone treatment!

It will simply thicken up thinning areas and then finasteride will maintain these cosmetic results.

Thats my opinion anyway

The bottom right looks thicker but nothing Propecia/Minox couldnt already achieve.

What we needed was proof this could grow hair on slick bald regions.

It cant.

For people with advanced hair loss - their better treatment will come in the form of better transplantation methods, such as the procedure invented by Dr Coen Gho.

Quote:

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Originally Posted by Desmond84

The results are not that bad! 19% increase in hair density is pretty decent.

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How much is 1 hair + 19% ? :rolleyes:

Admittedly boys, it's not where we'd hope to be.

Thanks for the post, Des.

I never expected this to be a stand alone treatment. I am thinking it can be a solid adjunct if it is not too expensive (or if the regenerated hairs can somehow be immunized to re-miniaturizing)
I would rather use this than rub in minox 2x every day

Quote:

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Originally Posted by Desmond84

It will simply thicken up thinning areas and then finasteride will maintain these cosmetic results.

Thats my opinion anyway

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So you think the "degradation rate" (hair count at 12 weeks vs 24 vs 48) can be helped with DHT blockers?

This is why I choose to not hang onto hope. This is very disappointing to say the least.

I got news for you, if you think Replicel is going to be our savior then you my friends will be disappointed once again. 19% density I'd take right now, but by the time Histogen is to be released (big if) I'll need a treatment to grow hair on my slick bald spots. This is deflating.

Time to research Gho further and take the plunge.

double post, apparently

The frustration lies in how many of cannot tolerate DHT blockers. For us, these 'results' are entirely grim.

Thanks Des!

I always thought Histogen's HSC was the most like Botox, and I don't think that changed with this news.

The longevity is less than I hoped for, but I wonder what is the toxicity of a Botox injection by comparison?

How many injections of each can you get at one time?

This is really disappointing

Why doesn't someone contact Histogen to quiz them about the results and implications for further trials. Can these be improved with a new trial?

They seem to think the results were exciting (yes I'm aware they are bound to say that)

Quote:

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Originally Posted by Desmond84

The results are not that bad! 19% increase in hair density is pretty decent. The question is what role does hsc play in terms of management of MPB. I suppose what these results show is that it will be an add-on therapy rather than a stand-alone treatment!

It will simply thicken up thinning areas and then finasteride will maintain these cosmetic results.

Thats my opinion anyway

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Will it be affordable as an 'add on' treatment for all but the very wealthy? That is the issue. Imagine if these injections cost €2000 or whatever, is that something most of us could justify each year, every year? On top of prescriptions for finasteride and minoxidil? Are the results even good enough for the company to afford to go through Phase 3?

Quote:

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Originally Posted by clandestine

The frustration lies in how many of cannot tolerate DHT blockers. For us, these 'results' are entirely grim.

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:( I guess CB and the elusive mystical PGD2 blockers and the only hope for those people, God knows how many years off those may be.

...damn

Quote:

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Originally Posted by Pentarou

Are the results even good enough for the company to afford to go through Phase 3?

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Looking at the results, it looks like you should almost get 2-3 treatments each year. But then again, that might adversely impact the hemoblogin count and thus bring health risks ...

Man, this surely is disappointing !

Another one bites the dust. Thanks for the find Des. My only hope is topical fin with minimal sides. Clan, that's what we should be waiting for. Start saving for a good HT.

At least we now understand why they have such difficulties finding investors ...

These are not new results! What are you talking ABOUT??? WAIT FOR OFFICIAL RESULTS!!

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Originally Posted by veca

These are not new results! What are you talking ABOUT??? WAIT FOR OFFICIAL RESULTS!!

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How is it not official?

Quote:

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Originally Posted by veca

These are not new results! What are you talking ABOUT??? WAIT FOR OFFICIAL RESULTS!!

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Eh ? just look at the document's name: HSC_final. Besides previous releases didnt contain 48 weeks data

I contacted HISTOGEN via e-mail, and here's what I got from them:

"Thank you for your interest and message. In the Phase I / II clinical trial of HSC, Which has recently passed the final timepoints, a Significant increase in vellus hair count was seen for the first time. this was in addition to improvement across efficacy measures, including total and terminal hair counts. this supports the hypothesis that the HSC treatment rescues dormant follicles, in addition to converting vellus to terminal hairs and becoming the number of hairs per follicle. However, there is much more to be learned in this area before mechanisms can be pointed to with any level of certainty.



While the Phase I / II has passed all timepoints, data from that trial is still being analyzed. I anticipate Histogen HSC will have updates to share in the next couple of months. The Company is not currently releasing any estimated timeframes for market introduction of HSC, however we can say that at least one additional clinical trial will be required in any geographic region where the HSC will be brought to market ..



I look forward to sharing HSC updates soon. Please do also check back to our website periodically for the latest news Histogen. "

I got this 10th May!

Quote:

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Originally Posted by veca

I contacted HISTOGEN via e-mail, and here's what I got from them:

"Thank you for your interest and message. In the Phase I / II clinical trial of HSC, Which has recently passed the final timepoints, a Significant increase in vellus hair count was seen for the first time. this was in addition to improvement across efficacy measures, including total and terminal hair counts. this supports the hypothesis that the HSC treatment rescues dormant follicles, in addition to converting vellus to terminal hairs and becoming the number of hairs per follicle. However, there is much more to be learned in this area before mechanisms can be pointed to with any level of certainty.



While the Phase I / II has passed all timepoints, data from that trial is still being analyzed. I anticipate Histogen HSC will have updates to share in the next couple of months. The Company is not currently releasing any estimated timeframes for market introduction of HSC, however we can say that at least one additional clinical trial will be required in any geographic region where the HSC will be brought to market ..



I look forward to sharing HSC updates soon. Please do also check back to our website periodically for the latest news Histogen. "

I got this 10th May!

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So you got this 3 weeks ago, they said they were to release this in the 'next few months', which is consistent with what they did.

I got this three weeks ago! Finally, the output from will be published in the "NEWS" on the official website HISTOGEN. Now, there are currently no news! http://www.histogen.com/aboutus/news.htm

Quote:

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Originally Posted by veca

I got this three weeks ago! Finally, the output from will be published in the "NEWS" on the official website HISTOGEN. Now, there are currently no news! http://www.histogen.com/aboutus/news.htm

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But again, look at how they named the document and how it contains 48 week's data. It must be final

I do not get too depressed .... at least until they are confirming this information! I just sent an e-mail, I hope that they will respond. To be honest, I've given too much hope in Histogen.