Histogen's Presentation 2014 (video) thanks to noisette

[Scientalk56]

Hello guys ! We have finally the histogen's presentation : Histogen - Company Presentation*: http://youtu.be/WIM-vA6l0u8

4:44 - 5:01
So We are 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 and to go into phase 1 for women here in the US.
We are also actively looking for partners both here and Asia.

[hellouser]

Two questions:

1) How long will this final approval take before they can roll out the procedure for commercial use?

2) Can they get conditional approval for commercial release in Japan during the final clinical trial in accordance to Japan's new legislation for stem cells, or is their method completely different and does not apply?

[noisette]

Great Idea for making an another thread on this video Thanks to you too Scientalk

[Scientalk56]

Two questions:

1) How long will this final approval take before they can roll out the procedure for commercial use?

2) Can they get conditional approval for commercial release in Japan during the final clinical trial in accordance to Japan's new legislation for stem cells, or is their method completely different and does not apply?

Well, that's a bunch of good important questions...
My question is will it be only phase 2b trial or phase 2b/3 trial...

[BoSox]

Vellus to terminal hairs. Music to my ears.

[whatsgoingon]

japan is the future. glorius nippon

[Westonci]

Everyone was saying Histogen was dead. Goes to show that everything should be taken with a grain of salt, and this includes peoples pessimism on this board.

What kind of timeframe can we expect? 2016?

[Haircure]

I think that a product will likely be released in 2018 given that they have yet to complete a phase 3 trial (which will likely take at least a year) and/or license it, and have clinics open to provide a treatment.

[nameless]

It sounds to me like they're saying next year they're doing the last clinical trial necessary for release in Japan and their clinical trials take about 1 year to complete so it sounds like they're saying that they'll be done with clinical trials for Japan the end of 2015 with release likely in late 2015 or early 2016.

This is what it looks like to me. But this looks a lot like AAPE and AAPE would be a lot cheaper.

[rdawg]

Two questions:

1) How long will this final approval take before they can roll out the procedure for commercial use?

2) Can they get conditional approval for commercial release in Japan during the final clinical trial in accordance to Japan's new legislation for stem cells, or is their method completely different and does not apply?

1 year for the trial +3-6 months for approval I believe, that's how it works with the FDA at least. My guess is Japan will be a little quicker to approve than the FDA takes, they are dreadfully slow.

so summer 2016? sounds about right, dont know about the 2nd question.

[rdawg]

Well, that's a bunch of good important questions...
My question is will it be only phase 2b trial or phase 2b/3 trial...

Isnt the law in Europe/Japan that they only need to go through phase I and II?

they've already done 2 Phases, this will probably be a smaller Phase IIb trial(60-80 patients instead of the hundreds needed for phase III trials) as it's much cheaper.

I just think Histogen hasnt found a partner as they dont believe this product is worth the trial costs(i.e putting it through phase IIb and III would cost millions) in order to gain approval.

I think Dutasteride just recently finished it's phase III trial as GSK didn't think it would make them over 500 million which they felt was the lower limit in order to pursue a phase III finish. Obviously they changed their mind though two years later. Here's the article talking about it, interestingly enough it's guarenteed to be the first drug approved for hair loss in 17 years within a few months!
http://www.****************/hair-los...e-pageid-1.php

[FearTheLoss]

DUT is in a different league though. It won't make much of an impact on the hair world because it is basically a more powerful fin, still with massive sides. Histogen doesn't have threatening sides.

[Bald Russian]

Never have been excited about Histogen, I aimed to some real cure. But this is good news anyway. Can anybody tell me how good are their results? What to expect? Will it turn NW6 to NW1 or maybe at least to NW3? Any photos before/after?

[rdawg]

DUT is in a different league though. It won't make much of an impact on the hair world because it is basically a more powerful fin, still with massive sides. Histogen doesn't have threatening sides.

Oh for sure, Im just talking about how serious companies take on the money side of things, DUT clearly works for hairloss in terms of maintanence for many(albeit causing bad sides for some) but because it's an older drug they dont feel its worth it.

the same issue may happen with Bimatoprost, it clearly helps to some extent with hairloss, but is it good enough to warrant a phase III and release? we'll find out after the january results.

[rdawg]

Never have been excited about Histogen, I aimed to some real cure. But this is good news anyway. Can anybody tell me how good are their results? What to expect? Will it turn NW6 to NW1 or maybe at least to NW3? Any photos before/after?

No idea, we'll see how well it works for agressive/diffuse hairloss sufferers as well, there's big difference between than and a NW3 45 year old guy, the slower sufferer will most likely have a better response.

in terms of their results before, it seemed to bump people up a norwood or at least cause some thickening, was nowhere near a cure. More of a much more powerful Minoxidil(lets say minoxidil caused <10% growth, histogen would cause 20-30%)

HOWEVER, that being said we dont know how well it will do in conjunction with FIN for example, mix them together and you may get a very good result(inhibiting whats hurting your hair and adding a growth stimulant= reversal of vellus hairs theoretically).