Histogen Update - Spencer Kobren Speaks With Dr. Craig L. Ziering

[DepressedByHairLoss]

I don't know about Histogen not beginning their clinical trials. I found a timeline on their website which apparently says that they've completed Phase I already. http://www.histogen.com/products/clinical_status.htm

[HairTalk]

I don't know about Histogen not beginning their clinical trials. I found a timeline on their website which apparently says that they've completed Phase I already. http://www.histogen.com/products/clinical_status.htm

They completed a pilot study in January of 2009. The graph to which you've provided a link has been on Histogen's Web site since at least early in 2011 — that pilot study is the only thing to which it could be referring.

What we're talking about is the phase I/II trial Histogen was supposed to begin on H.S.C., during June, 2011.

[Pate]

They completed a pilot study in January of 2009. The graph to which you've provided a link has been on Histogen's Web site since at least early in 2011 — that pilot study is the only thing to which it could be referring.

What we're talking about is the phase I/II trial Histogen was supposed to begin on H.S.C., during June, 2011.

Yep just to clarify, the pilot study was basically a Phase I that tested primarily safety with a single injection and secondarily efficacy.

This one is a I/II study for multiple injections and repeated injections, with both safety and efficacy as primary goals. It's also on a larger group (though not as much larger as we'd hoped).

So the Histogen timeline is starting to really slip. From memory Phase II has by far the greatest failure rate for clinical trials so if they can make it through this one there is a good chance of a product, but 2015 would seem the absolute earliest at this stage.

I wish they'd give us more info. But of these companies only Replicel is publicly-listed so they are only ones with a real desire to drive up the share price... hence IMO why Replicel have so far been the best at keeping us informed.

[Sogeking]

Where did you hear they had enrolled subjects who were on minoxidil and/or finasteride?

Ahh I can't remember, sure without evidence it doesn't really matter. I believe it was on hairsite. It was also given as reason for their late start with phase 2. But still what matters are pahse 2 trials they have started.

[RichardDawkins]

Hairsite any more questions?

Believe e when people here got full heads of hair again those hairsite lulers will still talk about more Gho proof

[UK_]

Any news?? I thought i'd take 6 months off but I just couldn't keep away any longer

[Sogeking]

Any news?? I thought i'd take 6 months off but I just couldn't keep away any longer

Hi UK. I was wondering where you went .
Apparently they(Histogen) started phase II trials in the beggining of December with 59 participants.
Most of us are eagerly awaiting phase I trial results from Replicel in late March. Until then there probably won't be anything to report .

[yeahyeahyeah]

Hairsite any more questions?

Believe e when people here got full heads of hair again those hairsite lulers will still talk about more Gho proof

Well has there been anyone who has got a full head of hair from ghos treatment.

[UK_]

Hi UK. I was wondering where you went .
Apparently they(Histogen) started phase II trials in the beggining of December with 59 participants.
Most of us are eagerly awaiting phase I trial results from Replicel in late March. Until then there probably won't be anything to report .

DECEMBER?!?!?!?!?!!!!

Chrissake what happend to starting the trials in June 2011? -

I bet you they were held up by that damn court case. Aderans should finish up phase II this summer when they hit 350 - then its a looooong wait through Phase III lol.

Any news on Intercytex? lol only joking

[Sogeking]

DECEMBER?!?!?!?!?!!!!

Chrissake what happend to starting the trials in June 2011? -

I bet you they were held up by that damn court case. Aderans should finish up phase II this summer when they hit 350 - then its a looooong wait through Phase III lol.

Any news on Intercytex? lol only joking

Actually I read somewhere, and it is really hazy, somewhat questionable that some of the first participants for phase II trials were actually using Minox or Fin, so they had to scrap it all, and start all over... They are wininng the lawsuit so that shouldn't give them any more problems.

As for Aderans yeah they are finishing their phasse II trials. If they enter phase III trials this year than we have something to be happy about. Also it seems the results are at first weak but compoundable .

I am still rooting for Replicel(I've been rooting for Trichoscience from the start). As for Follica I think they are mostly in research side of it all...

[HairTalk]

Hi UK. I was wondering where you went .
Apparently they(Histogen) started phase II trials in the beggining of December with 59 participants.
Most of us are eagerly awaiting phase I trial results from Replicel in late March. Until then there probably won't be anything to report .

That sounds like misinformation: Histogen is listed as currently recruiting subjects (http://clinicaltrials.gov/ct2/show/N...istogen&rank=1) (to-day is 1/7/2012) for this study. Unless one counts the period in which an investigational team searches for subjects (which, I believe, most people in this forum really would not), you cannot say the phase I/II trial started in December, 2011; the trial has yet to begin.

Now, I don't know whether the company indeed did begin work in June, 2011, and is now simply seeking to enroll additional persons, or they actually have "not yet done anything."

[Sogeking]

That sounds like misinformation: Histogen is listed as currently recruiting subjects (http://clinicaltrials.gov/ct2/show/N...istogen&rank=1) (to-day is 1/7/2012) for this study. Unless one counts the period in which an investigational team searches for subjects (which, I believe, most people in this forum really would not), you cannot say the phase I/II trial started in December, 2011; the trial has yet to begin.

Now, I don't know whether the company indeed did begin work in June, 2011, and is now simply seeking to enroll additional persons, or they actually have "not yet done anything."

Hmm that is possible. Actually it was said in this thread that they've started phase II trials. So I'm sorry if it was wrong. I just did not check that.
Thank you for the correction.

[2020]

stupid question:

from what I understand, this new treatment will ENCOURAGE HAIR GROWTH, right?
I'm sure it will work but the problem is that those new hairs are still going to be susceptible to DHT... wouldn't those new hairs continue "shrinking" from DHT?



ALSO: the guy in the interview said something like this:

... there are better ways to make money, but we love what we're doing so we'll keep doing it...


huh??? wouldn't this make A TON of money considering how many balding men there are WORLDWIDE???
unless most men don't care about losing hair...

[Kampung101]

stupid question:

from what I understand, this new treatment will ENCOURAGE HAIR GROWTH, right?
I'm sure it will work but the problem is that those new hairs are still going to be susceptible to DHT... wouldn't those new hairs continue "shrinking" from DHT?

Yes, the wnt proteins and growth factors from your own body that the treatment uses is supposed to encourage hair growth (and the phase 1 results show it does). As for susceptibility to dht, thats what they are going to have to find out through the entire trial process. After 2 years, the participants from phase 1 still had all the hair they grew back intact. Whether that means the hairs are now permanently resistant to dht or will last for the amount of years your hair was intact before the balding process began is still a question mark.

[Pate]

As for Aderans yeah they are finishing their phasse II trials. If they enter phase III trials this year than we have something to be happy about. Also it seems the results are at first weak but compoundable .

I think the results were weak at first because they were still perfecting the formula. In the presentation video by Washenik that you can find online he shows a graph that shows results weren't great at first but with each new trial they got a bit better.

On top of that they seem to be doing the first tests on whether it's compoundable, with anecdotal reports suggesting it is. All in all they may have a theoretically less perfect solution than Replicel, but until Replicel show us some results Aderans seem to be the leaders in the field. Looks like they will get it to market first too given Histogen's delays.

As for Follica I think they are mostly in research side of it all...

Follica seem to be the Dark Horse in all this, they have an official policy of not commenting on R&D. Which is really annoying for us, but I guess it does mean there's a faint prospect of them suddenly announcing they've cracked it.