Histogen Update - Oct 22, 2014 Presentation

hellouser

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Looks like Histogen is moving forward with work in Japan:

[video=youtube;WIM-vA6l0u8]https://www.youtube.com/watch?v=WIM-vA6l0u8[/video]

Pay close attention to what she says at 4:45

'So we're moving forward right now with the strategy to do our final clinical trial for approval in Japan starting early next year for male pattern baldness.'
 

albionlad

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If the clinical study is done in Japan, does that affect the treatment being available in other countries?
 

Future_HT_Doc

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Very interesting to see a company taking advantage of Japan's awesome new stem cell laws. I'm sure others will follow suit.

I have a few questions/issues, however - and maybe you can clarify Hellhouser:

1. It's interesting that Gail says "the strategy to do ..." opposed to "we are doing our final clinical trial in Japan." Especially because she said this a minute or two before she states that they are looking for investors for the HSC project. The reason I bring that up is because I thought Dr. Craig Ziering - a year or so back - made it sound like they ran out of funding after the lawsuit/phase I trials in the US. Is the plan to move forward with phase II in Japan if they can get investors? Or do they have sufficient funding and I'm reading too much into this? Didn't it say somewhere on the site that they need $23 million for the HSC project? I'm wondering if stating that they WOULD move forward in Japan asap was a way to entice investors?

2. It's also interesting that they are hoping for phase II trials in Japan for Androgenetic Alopecia, but specify that they will start phase I for female pattern hair loss in the US. This leads me to another question ...

3. Is the image showing the trichoscan with the marked improvement at 12 months from a female? I ask this because if you look at the data, it really shows that the biggest increase is seen in the terminal hair count. It stands to reason that this means HSC revitalizes miniaturized hair follicles producing vellus hairs and shifts follicles from miniaturized, vellus states to normal cycling hair follicles. However, the HSC does not, from what I can tell, do anything to affect the expression of DHT receptors in the follicle cells. This means that in patients with elevated DHT, these revitalized hair follicles would still be susceptible to future miniaturization. This brings me back to my question about the picture and the interesting fact that they are seeking phase I specifically for females in the US: only 40% of women with FPHL response to anti-androgen agents. From this data, researchers have concluded that only around 40% of FPHL is caused by androgen excess (DHT susceptibility). If this women had a type of FPHL that was not related to androgen excess, it stands to reason that her follicles could be revitalized by the serum AND retain normal function at the 12 month mark because there was no further insult from increased DHT (aka androgens). If this is the case, however, will the treatment be as effective in men with Androgenetic Alopecia - which, as you all know, is initiated by DHT susceptible follicle cells binding with DHT?? Is this why they are conducting phase I trials exclusively for females in the US?

- - - Updated - - -

Albion,

Yes, it would. They could not, for example, offer the treatment in the US without phase I -> III trials.
 

maher

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Thats nice, but I'm not losing my cool over some treatment that is supposed to be on on market in min. 3 years, in Japan. Maybe they can produce DIY kit and sell it on ebay for 199$. Now, that would be exciting.
 

hellouser

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Thats nice, but I'm not losing my cool over some treatment that is supposed to be on on market in min. 3 years, in Japan. Maybe they can produce DIY kit and sell it on ebay for 199$. Now, that would be exciting.

Please refrain from making such comments, it's misleading to the hair loss community.

- - - Updated - - -

If the clinical study is done in Japan, does that affect the treatment being available in other countries?

It could be approved for Japan today or 10 years ago, it'd still need to go through the FDA's torturous process for another 10 years (and expect delays too).
 

Fbalding84

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In my opinion, these statement do mean squad. In my line of work we also exaggerate when we present in front of a crowd of peers. 1 to attract investors 2 to piss of our competitors
 

TheShining

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[FONT=Verdana, Arial, Tahoma, Calibri, Geneva, sans-serif]Can someone explain the basic difference between histogen and Replicel to me? From what I have read and understand Histogen shows better result and are closer to a release, compared to Replicel. Still Replicel get much more attention and interest here on the forum. Why is that?[/FONT]
 

benjt

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Have a look at this post.

I, personally, am not sure yet if Histogen's HSC safety trials were sufficient. Yes, they followed a typical phase 1 protocol, but as Wnts can increase cancer risks such trials should take much longer for something like HSC. At least that's what I think, but I got no real clue about that. Now the thing with RepliCel is its 100% perfect safety profile and the fact that multiple treatment sessions lead to multiple growth boosts. This is why I personally prefer RepliCel. Also, I am not sure who is actually further, but I think again its RepliCel because they have the facility in Japan and Shiseido as a distributor for SEA.
 

maher

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Have a look at this post.

I, personally, am not sure yet if Histogen's HSC safety trials were sufficient. Yes, they followed a typical phase 1 protocol, but as Wnts can increase cancer risks such trials should take much longer for something like HSC. At least that's what I think, but I got no real clue about that. Now the thing with RepliCel is its 100% perfect safety profile and the fact that multiple treatment sessions lead to multiple growth boosts. This is why I personally prefer RepliCel. Also, I am not sure who is actually further, but I think again its RepliCel because they have the facility in Japan and Shiseido as a distributor for SEA.

So, you're saying that there is a chance for cells to mutate, and cancer cells developing. EMA will never approve this. FDA maybe.

Do you think these "new" follicles will be DHT sensitive? (RepliCel)
 

Fbalding84

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More importantly than the sensitivety of the follicle is how do hair transplants performed previously affect the area where the follicles have been planted. Should we expect a loss of minuturized follicle that could have been revived with histo/repicell???? Due to the incision make can we assume those follicles are lost permanently and damaged in the process of a hairtransplant??

If so, should we wait and not get a transplant in hopes of future cures??
 

benjt

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So, you're saying that there is a chance for cells to mutate, and cancer cells developing.
This is what some Stanford researcher said at the Stem Cell Meeting on the Mesa. I still haven't dug deeper into the matter. Question is also how big this chance is; if its "virtually zero" and only one in one million treated actually gets cancer from it within the following ten years, a) how can you tell and b) would it be "that bad"? The latter question is subjective, but given how desperate many people are to have their hair back...

Do you think these "new" follicles will be DHT sensitive? (RepliCel)
I thought they would be, but according to RepliCel they won't because the DSC cells they harvest for restoring the follicle to old health will be taken from the back of the scalp. See the excerpt from an interview with their CEO in this post.
 

Future_HT_Doc

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Maher,

That's the problem with injecting growth factors; once they are in the body, it is very difficult for them to make "good" things grow without also making "bad" things grow. For example, they may support DP cell growth and proliferation, but they could also support growth and proliferation of other, non-targeted cells (ie a tumor). The problem, as well, is that it wouldn't really take a pre-formed malignancy for these cells to cause a problem. We experience inappropriate cell growth, improper genetic coding, incorrect division, etc, on a daily basis, but our body contains mechanisms to compensate and stop the problem before it really becomes bad. If we shift the body into a permanent anabolic state, however, with growth factors, issues could occur. Like Ben said too, it's difficult to interpret the safety trials - in my opinion - because these types of issues often happen over a longer period (not just during the 12 months its evaluated during a safety trial). Now, absolutely no one knows if this would happen for sure, but there will always be concern with injecting growth factors.

In my opinion, I think it's difficult to say that the cells will or will not be DHT resistant. In the video, David Hall states that the cells are taken from a DHT resistant region of the scalp. However, I was under the impression that the androgen receptors on the DP cells, not the DSC cells were the issue. If new DSC cells are implanted and support existing DP cells without creating new ones, the same androgenic receptors will exist (and they will still be prone to DHT). Maybe I'm interpreting it wrong and someone can clarify?
 

maher

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Guys, tnx for your explanations. I'm sure as trials go on, this will(have to) all clear up.
 

hellouser

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Yes, all we can do now is wait.

Thankfully and finally with Histogen and Replicel only needing ONE trial in a speedy environment like Japan, it won't be too long. Thank god.
 

benjt

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I wish. I am not familiar with the new Japanese legislation (and it actually hasn't been passed yet), but I think the reason why Shiseido are doing their trials now is that the fast-track approval trials need to be in Japan, maybe? That means that Shiseido needs to finish first and they even haven't started their trials yet.

Also, what is absolutely for sure is that the low number of doctors that will be trained and licensed to perform RepliCel's treatment will be a huge bottleneck. RepliCel estimates that only a few thousand people can be treated per year for the first few years after initial market availability. So even after their treatment is on the market and the cell multiplication facility is running, it will take some time until most people can get treatment.
 

hellouser

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I wish. I am not familiar with the new Japanese legislation (and it actually hasn't been passed yet)

It's going to be passed in about 2 weeks/some time this November. David Hall from Replicel mentions this as well as by Yoshihide Esaki (director at ministry of economy):

http://youtu.be/3dB5yK2k8-w

but I think the reason why Shiseido are doing their trials now is that the fast-track approval trials need to be in Japan, maybe? That means that Shiseido needs to finish first and they even haven't started their trials yet.

AFAIK, conditional release during Phase II trials is possible, so once safety is known during the next trial with Shiseido, they can then move forward with bringing it to the masses.
 
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