Histogen Update

[hellouser]

Hey hellouser,

What you're referring to are called Phase 4 trials (Post-approval) studies.

First of all, they're conducted after the drug is on the market, so don't worry you'll get to use it while they're conducting these studies.

Secondly, there are TWO main reasons why these studies are conducted:
1) FDA has asked them to conduct a long-term safety study (for risk of cancer, mortality, etc) which would most probably be the case for a biological drug like histogen that contains Wnt proteins.

2) Companies themselves decide to conduct these studies, to evaluate further potentials of their drug and broaden its indications. This could be things like:
- the compounding effects of 4 treatments at 6 weeks intervals vs. 2 treatments at 6 weeks interval
- how long does their treatment last
-etc

Another good news I can give you "hellouser" is that when you look at a company's study design, you can tell who they're targeting their product for.

FDA is big on "placebo-controlled" trials meaning you have to test your drug against a placebo group.

Europe is more of a fan of "your drug vs. our current gold standard" (i.e. Propecia/minoxidil).

So far, histogen's been conducting a "placebo-controlled" trial, where one side of scalp received Histogen's HSC complex while the other side received a placebo shot!

This most probably means their priority is a US launch. We'll know for sure when we find out the design of their Phase III trials. If its placebo-controlled, FDA will not be too harsh on them and you would see the product in US by 2015-2016 if all goes well.

Hope that clarifies your concerns, and don't hesitate to ask me any questions. I'd be more than glad to help

GREAT feedback! This is exactly the kind of stuff that makes it such a pleasure being part of this forum, thank you!

A 2015-16 commercial date sounds reasonable! I'm somewhat lucky because my hairline has receded significantly in the last 8 years causing a big widows peak although my crown hasn't been affected other than thinning (though not noticeable). That said, I could opt out for a Gho treatment or with Dr. Rahal for my hairline and continue my Minox/RU58841 regimen until Histogen or Aderans becomes available which would basically be a permanent solution effectively going back to a norwood 0 or 1.

Thanks again!

[rdawg]

Another good news I can give you "hellouser" is that when you look at a company's study design, you can tell who they're targeting their product for.

FDA is big on "placebo-controlled" trials meaning you have to test your drug against a placebo group.

Europe is more of a fan of "your drug vs. our current gold standard" (i.e. Propecia/minoxidil).

So far, histogen's been conducting a "placebo-controlled" trial, where one side of scalp received Histogen's HSC complex while the other side received a placebo shot!

This most probably means their priority is a US launch. We'll know for sure when we find out the design of their Phase III trials. If its placebo-controlled, FDA will not be too harsh on them and you would see the product in US by 2015-2016 if all goes well.

Hope that clarifies your concerns, and don't hesitate to ask me any questions. I'd be more than glad to help

Do you have any inside knowledge of any of these trials?
Thank you for the information though.

and is it true there is usually a 9 month wait after the phase III trials finish to get approval?

[rdawg]

http://www.prweb.com/releases/2012/10/prweb10032346.htm

press release from histogen, looks like it will be getting approved to go into phase III as the results are fairly positive.

seems(if i'm reading this right) after months on the treatment, growth was anywhere from 20%-40%. Sounds like a great solution for moderate hairloss sufferers,maybe with some tweaks it could be used for NW4++

[UK_]

http://www.prweb.com/releases/2012/10/prweb10032346.htm

press release from histogen, looks like it will be getting approved to go into phase III as the results are fairly positive.

seems(if i'm reading this right) after months on the treatment, growth was anywhere from 20%-40%. Sounds like a great solution for moderate hairloss sufferers,maybe with some tweaks it could be used for NW4++

An 86% responder rate which represents the given responder rate in their first pilot study - I am pleased to hear they are now gearing up for a phase 3 -

What do you 2009/2010 naysayers think now? What about you, Tin_Man?

*tumble weed/crickets?*

[rdawg]

An 86% responder rate which represents the given responder rate in their first pilot study - I am pleased to hear they are now gearing up for a phase 3 -

What do you 2009/2010 naysayers think now? What about you, Tin_Man?

*tumble weed/crickets?*

I guess the people saying nothing will come out ever can stop saying it!! it looks like we're getting a solid product by 2016!

[new bubble]

I guess the people saying nothing will come out ever can stop saying it!! it looks like we're getting a solid product by 2016!

GAME CHANGER now watch allergan aderans and others keep the positive news flowing and products like rogaine, fin and others finally up there game and give us what we want

[rdawg]

GAME CHANGER now watch allergan aderans and others keep the positive news flowing and products like rogaine, fin and others finally up there game and give us what we want

Allergan seems to have a positive announcement coming so my guess is that's the next product out.

Essentially we have Allergan hitting a late 2014 release, then Histogen a year or two after.

more products the better, as you never know what using them at the same time can give you!

[UK_]

I guess the people saying nothing will come out ever can stop saying it!! it looks like we're getting a solid product by 2016!

This is the balding community lol - people will find anything to moan about, someone will come on here soon enough and make a comment about the results.

[UK_]

Histogen grew hair on temporal regions!!!!!

[UK_]

Gail: "Available non-surgical treatment options for alopecia focus on younger patients in the earlier stages of hair loss, with a primary purpose of retaining existing hair and supporting limited hair regrowth. This is not the trend seen in the clinical trials of HSC. In both the pilot and Phase I/II clinical trial, HSC treatment has shown efficacy across age groups, with subjects age 40-59 seeing cosmetically significant results beginning at 12 weeks, including a mean increase of 39% in terminal hairs and 19.4% in total hair count in this age group in the current trial."

HAHAHAHAHA that is my ****ing age group - ive waited all this time to laugh at you young ****ers moaning about being a NW1.1!!!

Looks like this product is going to be effective then even if the hair loss has been present for over 20 years, that is truly groudbreaking, can anyone tell me whether Finasteride or Minox or Neogenic is capable of doing that? ahahhhaa