Spencer Kobren Speaks To Dr. Craig Ziering - Histogen’s HSC Update 6/16/12
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pretty weird, but the main update is still coming in october so yea.Comment
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what stage are they in and at how many months in will they be when they announce results in OCT?Comment
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From what I can tell they either go into Phase II part 2 in January 2013 or Phase III.
they'll be about 10 months in when they announce results in October.Comment
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Thanks for checking rdawg I couldnt find anything - it is strange being that the presentation is advertised on Histogens 'upcoming events' section of their website - I only ask because mid-October still feels far away lol.Comment
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I dont know, maybe they will maybe they'll go straight to Phase III. You know I remember Gail stating way back in 2010 that the product could be due for pan-Asian release as early as late 2013, but who knows.Comment
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I suspect they will do a proper Phase IIb before a Phase III, much as I hope they go straight to Phase III. But I don't see anything in that clinicaltrials.gov record that clarifies they're doing Phase I/II part 2?
If anything, this is Phase I/II part 2, because the original study was I/II part 1.Comment
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Sorry, how does it clarify that? I must be missing something.
I suspect they will do a proper Phase IIb before a Phase III, much as I hope they go straight to Phase III. But I don't see anything in that clinicaltrials.gov record that clarifies they're doing Phase I/II part 2?
If anything, this is Phase I/II part 2, because the original study was I/II part 1.
either way if it passes this phase, it's ONLY good news, and depending on the results we could know it already works whether it's going into phase IIb or phase III.
this is only for europe though, NA is going to be behind a year or two even after approval of this in europe(if it gets that far.)
if this passes in december to the next phase, we're looking at a late 2014 launch in Europe/Asia and late 2015-2016 launch in NA.Comment
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ie the formulation tested contains both HSC and DMEM (which is the cell conditioning serum that grows the fibroblasts), and the formulation is being tested in both Phase I and Phase II.
But yeah, no matter what it is, the 3 month results were fantastic. I'm waiting impatiently for the next results. One of the subjects nearly doubled his total and terminal hair counts at 3 months - his results at 12 months will be very interesting. Subject S1027 in the previous trial only had 5% more total hair at 3 months, but 50% more at 12 months.Comment
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If it only adds density or reverses vellus hairs, that's still great for thinning or moderate hair sufferers.Comment
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The guy from histogen interviewed in june said they had JUST injected a slick bald area on a new test patient. so it's been about 3-4 months. Undoubtedly we'll find out in October.
If it only adds density or reverses vellus hairs, that's still great for thinning or moderate hair sufferers.
They could actually distribute this product as a treatment to have every 6 months after a HT to ensure continued hair growth on top of transplanted grafts.Comment
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