Histogen 02-20-2016 (never Seen This Document Before)

Xaser94

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https://www.zacksinvest.com/sites/default/files/offer_files/Histogen PPM February 20 2016.pdf

Hey guys, I really dont know if this has been posted before. I dont think it has, because I remember scouring the ZacksInvestment page that was linked in the Histogen page. I guess once they got that intital 9 million or whatever and updated it to 18 million, they added this document which may have only been privy for certain investors back then, but now linked in the ZacksInvestment page as well.

There is some interesting info in here.

"MEXICO PHASE 3 TRIAL In 2015 the company partnered with a leading stem cell treatment company in Mexico for approval and roll out of HSC in that market. The company was granted an option for testing and a long term license with a supply agreement to deploy HSC in Mexico following its approval by COFEPRIS (the Mexican FDA). This is a large study being designed to treat 300 subjects in the company’s existing clinics with a 4:1 randomization to HSC or placebo. Fifty injections will be administered at baseline and an additional 50 injections at week 6. Subjects will be followed for one year and the primary safety and efficacy endpoints will be assessed at week 18. All costs of the study being paid by our Mexican partner. Initial meetings with COFEPRIS have indicated that the company will be permitted to move directly into Phase 3 on the strength of prior work in Latin America and Asia. That prospect is currently being followed up to permit final study design and filing of an application in Mexico by the second quarter of 2016. Approval for the commercial roll out of HSC in clinics throughout Mexico is targeted for late 2017/early 2018. The partner plans to actively promote HSC treatments as both a domestic hair loss solution and as a medical tourism business.

JAPAN PHASE 3 TRIAL The company is negotiating with a partner for a similar arrangement for Japan – an option for a license and supply agreement preceded by a study of the product for approval in the country of Japan. All funding for this study will be provided by the partner as well."

I think the picture with the man who is around nw4 who got really good regrowth only had 20 injections and another 20 injection regrowth, so this trial may bring even better results with 50 injections and another 50 injections!

"It should be noted that while clinical tests to date indicate that a large percentage of patients respond to HSC, not all do."

Thought this was interesting and wondering if there was a common factor between people it didnt work for. Maybe when someone was slick bald for too long?

"In summary, clinical data to date shows that HSC has benefits that other products do not offer – hair growth appearing to be permanent 2 years after tests, temporal recession restoration, effectiveness in men over 40, and efficacy in female patients. HSC offers the potential as a standalone alternative treatment option or an opportunity to be given in conjunction with other treatments or products. It has the potential to improve results as a follow on treatment to hair restoration surgeries, offer an option to patients who are not candidates for surgery, and to be a more effective option for those presently using or considering Rogaine or Propecia."

I think some people were wondering how long the results last, and to my knowledge they never specifically said so knowing they are permanent for atleast 2 years is nice . I know this isnt recent news but there is alot of interesting stuff in there, especially about how they plan to roll out Histogen, and what they think of their competition along with more detail about their individual trials.

If anyone is in touch with Histogen, knowing if they started their trials in Mexico would be huge!
 

pegasus2

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If this thing comes out in Japan before Mexico I'm gonna be mad. I'm already going to be making at least 3 trips to Japan between Replicel and Tsuji. Mexico would be so much easier and cheaper.
 

Blackber

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If this thing comes out in Japan before Mexico I'm gonna be mad. I'm already going to be making at least 3 trips to Japan between Replicel and Tsuji. Mexico would be so much easier and cheaper.
Lol tell me about it!

If it's Mexico I could fly there and back in one day.

They've already secured a partner in Mexico and have been given approval to commence trials there as well. In Japan they haven't secured a partner or received clinical trial approval - which if we take into account how long Replicel had to wait for trial approval I highly doubt Japan will beat Mexico on this treatment.
 

hellouser

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Oh man, I'd LOVE for this to get released in Japan just before the 2017 Hair Congress in Kyoto, I'm definitely down to go and report again about new progress AND could go in for some injections. You guys know I can document the hell out of a regimen, so... BONUS!
 

Blackber

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Oh man, I'd LOVE for this to get released in Japan just before the 2017 Hair Congress in Kyoto, I'm definitely down to go and report again about new progress AND could go in for some injections. You guys know I can document the hell out of a regimen, so... BONUS!
I'd glady help fund your mission to get there either way!
 

Blackber

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Please please PLEASE don't turn this into a debate on this picture - see the attached.

Although if you can't admit there's noticeable regrowth in this picture you need glasses and a mental healthy professional.

The reason I'm posting it is to show that this patient was given 20 injections on two separate occasions. The trial is Mexico is for 50 injections on two different occasions. Hopefully we see even better results.
 

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kawnshawn

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I certainly hope that the effects last longer than two years. Correct me if I'm wrong but doesn't Histogen need to take a scalp biopsy just like Replicel? I would have reservations going back each time if I would need to have another scalp biopsy. Still very exciting news though.
 

jc3303

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I certainly hope that the effects last longer than two years. Correct me if I'm wrong but doesn't Histogen need to take a scalp biopsy just like Replicel? I would have reservations going back each time if I would need to have another scalp biopsy. Still very exciting news though.

They don't need a biopsy, which is why I'm very excited for this. It could make this as easy as getting the injections and going on your way.
 

hellouser

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Hmm, next question for Histogen should be this:

Follicles that grow terminal hair have dermal papilla cell counts between 1,400 - 3,000 cells. Has Histogen looked into the follicles after HSC injections to see if the DP cell count has increased? Wouldn't it have to considering (as far as we know) the hair size is relative to the size of the follicle which depends on the DP cell count? If the DP cell count is higher, would that mean that Histogen has figured out a way to migrate the DP cells back to the DP and follicle?

I spoke with Dr. Claire Higgins and she mentioned that a simpler method of reversing hair loss would be to get the DP cells to come BACK to the follicle.
 

Torin

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I spoke with Dr. Claire Higgins and she mentioned that a simpler method of reversing hair loss would be to get the DP cells to come BACK to the follicle.


Is Replicel/Shiseido trying to do that with their method?
 

Afro_Vacancy

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Wouldn't it be expensive to keep going to Mexico over and over again? I thought histogen required multiple treatments?
 

farkhairloss

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This is my most anticipated treatment. We have pictures both micro and macro, and proper trial figures. (Unlike Dr Brutzi's magical potion, perhaps he should add some jizz into his it). Now just hurry up and release it, Mexico isn't the closest destination from Australia, but I will do what it takes to get there if it becomes available ;)
 
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