Histogen Presentation April 2019
After initiating a rousing new trial for female hair loss last year, Histogen has been back on many people’s radar again. A video of Histogen’s recent presentation in New York City has been uploaded online and it contains some interesting items from the company.
New CEO
One news item coming from Histogen earlier this year was the appointing of new CEO and Chairman Richard Pascoe. He is featured in the presentation along with longtime Histogen executive Gail Naughton. Pascoe has a background in the biotech industry raising large amounts of capital and leading companies to strategic partnerships and buyouts. Naturally, Histogen is hoping that he can continue his streak of successes with them.
HSC As A Cosmetic Product?
I’m going to cut to the chase on this one. The most interesting topic I heard mentioned in this video at the 7:40 mark was Richard Pascoe mentioning:
“…we also believe there is tremendous opportunity in the retail skincare market where we could take the CCM product and put it into any number of cosmetic type products that could treat the skin, the hair, and other things…”
Briefly, the CCM product is the “cell conditioned media” that Histogen creates from fibroblast cells to create its HSC660 (hair stimulating complex) serum. All signs would point to the CCM being used to create a topical hair growth product. To be clear, it was not spelled out during the presentation that this is the case but I don’t really see how the CCM would be used for anything other than a retail hair growth topical product. There’s certainly no need to use a CCM to create a styling gel or shampoo.
Clinical Trial Forecast For HSC 2019
The video displays a timeline chart around the 3:07 mark of the video. This chart proposes that data from the phase 1 female hair loss clinical trial will be announced in the 2nd quarter of 2019. At this point we can guess the data will be shared sometime between June and July, stay tuned for an update on that. The chart also optimistically aims at a 4th quarter 2019 time table for the initiation of the follow up phase 2 trial for females.
Its also mentioned in the video that Histogen is looking to initiate a phase 2 trial for male androgenic alopecia which is somewhat mysteriously about 10 years in the making. No definite timeline was mentioned for this trial.
One topic that was not mentioned in the video is Hisotgen’s phase 3 trial for men which was initiated in Mexico last year in 2018. Presumably, this trial is still underway and there is not a need to mention it currently. An update could come later in 2019.
Now that Allergan is no longer suing Histogen and has become a business partner it would seem like product development for the company would be seamless. Everyone knows that HSC works for hair growth and they have a huge partner in Asia (Huapoint) and a major ally in North America (Allergan), you would think Histogen would be stampeding towards the finish line at this point. Hopefully we hear more about meaningful developments for Histogen over the next 6 months.
Thank you for linking to this article when sharing it and thanks to Corwin for the tip.
Posted in Hair Growth Treatment, Histogen
They state that their next objective is to move into a phase 2 trial with their new hair product in men. It seems like they must have abandoned their previous HSC formulation that was supposed to be in phase 3 trials in mexico.
This is not necessarily accurate, there has been no announcement of abandonment.
What is your basis for this? The only information we have that they may be in phase 3 in Mexico was from an interview article with Gail which may have been a misunderstanding in the article, or not a for sure thing at that point. It seems like a phase 3 for this company would be something they would be advertising everywhere as a major goal reached, especially as they are still trying to get financing.
Thanks for reading. It was stated in a major news publication. It wasn’t a misunderstanding or Histogen would have called them to correct it. Histogen read that article.
I guess what we can take from the presentation is that they are moving foward and that they have already commercial skin care products in the market.
For us, the crucial development will be what is happening in Mexico. Sadly, no mention of this. Is it a bad sign? No idea, but at least the competition is moving forward too..be it Celino or Follica. That should be an incentive for Histogen to speed up things.
thank you to the followers who always get us the latest news
I’m very happy to help. Let me know if there’s any other way I can volunteer.
What I do not understand is how to make a future Phase 2 trial, when there is one in progress for phase 3? What does this mean?
One is in USA (phase 2) and Mexico is in phase 3.
The Phase 3 trial for Histogen started on July of 2018. And typically Phase 3 studies are 12 months I believe?
I’d be interesting to see if Shiseido possibly announcing RCH-01 in July impacts Histogens timeline. First to market alway’s gives that extra edge to the first company.
Does anybody know if Histogen has to only launch in Mexico and/or when could they launch in the US? I’d imagine the US is the real prize market to enter.
Shiseido has a partnership (in Japan) with Replicel, another biotech company working on stem cell research for hair loss
US is definitely the prime market to enter and Histogen just has to meet safety guidelines for the FDA. It will still be arond 4-5 years before Histogen could be approved in US.
Hello Joseph, it has been quiet re Huapoint and the use of HSC in China. I thought first that their cooperation collapsed.
Anyway, as I am living in Austria I would rather prefer flying to China for treatment instead of Mexico, once HSC hits the market.
Have you got any detailed Huapoint info?
Thanks
M
I’d have to guess that they are still working with regulatory officials in China to get approved for a trial.
Perhaps they sent the new HSC660 data to China to help build a case to convince the authorities in China for a phase 3 trial there? Just a hypothesis.
Sounds promising, although when it comes to flaky Histogen I always feel a bit like Charlie Brown determined to really, truly kick that football before Lucy yanks it away yet again. BUT, in the spirit of Oddball (Kelly’s Heroes), I’ll dispense with the negative waves.
Phase 2 starting for men? I thought they completed a phase 2 for men years ago. That phase 3 was left for USA approval and that phase 3 started in Mexico last year? Something doesn’t add up right. Maybe phase 2 is for their new HSC product ? Can’t believe this company has been doing trials since 2009 and still so far behind. Sad sad business development team and operation at Histogen. I had the most promise for this company in early 2010. It would have saved my density and hairline. I’m actually really mad at them.
I guess that trial in Honduras was considered a phase 1/2, but they did start a phase 3 for men in Mexico. Mexico has different regulations. Yes, the Histogen story has been frustrating for a lot of people. It’s been a lot of legal issues for the company and only they know the whole story. Certainly a very odd case.
Hairguy, you’ve crystalized my thoughts perfectly. These guys were on a fast track and they sat on their laurels for half a decade and did nothing while the competition waved bye-bye in the rear view mirror. Gross mismanagement.
Any news on histogen? Admin, how could they have skipped a phase 2 and go to phase 3 in mexico? They def did a phase 2 back in 2016 I believe and released pics. I have a feeling they are going to shelf the old hsc and start phase 1 of new hsc here in the states. So we are looking at another 7 years or so. I mean I don’t know whether to laugh or cry. It’s just hair and nobody can bring a solution. I give up……
Histogen completed a pilot study in 2009 and then a phase I/II in 2012. In addition to that it completed a physician sponsored trial with Dr. Craig Ziering. Because of all that combined data, that is how the company was able to convince the Mexican authorities to allow it to go into a phase 3 clinical trial. There’s no reason at this point to believe they are not continuing with their phase 3 in Mexico which was previously announced. However, it is possible that the trial stopped. Companies tend to stay on the quiet side.
In the post above, it says that in the video there is a phase 2 trial that maybe on for men and that it may take another 10 years.
Does that mean we still have so long to wait for?
It meant to say that the phase 2 trial for men has been waiting about 8 years to begin. As far as how long it could take to enter market, that’s another case. I would say at least 4 more years.