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So it's likely that they will have to conduct new trials?? Which could go on for several years.Comment
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What old trials? Can you provide the from-to dates of the trials you're talking about?
As far as I can tell, they gained approval and patented a number of compounds back in 2010 (one of them being lithium for hair loss) and began A clinical trial in that year, now we have the results of that trial.
How is this news therefore related to old findings of old trials? FGF9 is part of the entire hypothesis - the compounds used are clearly aimed at altering the gene in question as the following clearly states:
"This discovery sheds light on a novel mechanism to regenerate hair follicles and opens an exciting new avenue to develop treatments for hair loss in humans," noted Dr. William Ju of Follica, Inc. "Follica has developed a technology platform that is uniquely suited to support clinical translation of these new findings. The Follica platform can be used to induce skin reepithelialization, which creates a "window of opportunity" during which the Fgf9 pathway could be modulated to potentiate hair neogenesis."Comment
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2% increase in terminal hairs, tho neogenesis was achieved
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Apparently this is not the correct phase 2a trial. this was a separate one that run in conjunction.
Quoting from a poster at HS
Follica conducted two different studies that we know of. One had wounding and no topical compound, the other had wounding with a topical compound (Lithium). The former actually exhibited modest hair growth. We still have no indication of efficacy for the latter.
Follica do not make this easy to follow lol.Comment
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Hey brother
Welcome to BTT...so this study that was published was conducted in humans! That is definitely worth a read!!!
Guys is anyone able to access this article and either post it on this site or email it to me or anyone you like...let's see if it is really as ground breaking as everyone thinks it is...here's the link:
Thanks in advance btw
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That article you linked us to isnt what they're talking about in the following segment:Hey brother
Welcome to BTT...so this study that was published was conducted in humans! That is definitely worth a read!!!
Guys is anyone able to access this article and either post it on this site or email it to me or anyone you like...let's see if it is really as ground breaking as everyone thinks it is...here's the link:
Thanks in advance btw
Follica have run a number of human trials based upon the theoretical work associated with mouse studies and FGF9 including a human preclinical trial, that particular work is not related to the link you posted. Follica are immensely secretive, it's very difficult to know exactly what they're up to, however I have never seen them come out and state in a news release they have shown human hair follicle regeneration, that is important to note.Follica has conducted preclinical testing of proprietary device configurations for skin disruption in combination with a number of known and novel drugs. The company has run a series of human clinical trials, including a Phase IIa trial, which have demonstrated follicular neogenesis in humans for the first time. These trials pave the way for the development of a breakthrough combination of a device to produce targeted skin perturbation coupled with a well-studied drug compound.Comment
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Well we have some indication here:
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Articles about Follica Breakthrough...
1- http://www.xconomy.com/boston/2013/0...dness-therapy/
2- http://www.marketwatch.com/story/new...ess-2013-06-03
3- http://www.follicabio.com/news/folli...stigationi-44/Comment
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Hmmm, Hariri all those 3 links use the Nature Medicine article as their reference!
They also mention that these new findings were conducted in mice...they still need to conduct a small human trial to test for efficacy!
So the first step is to culture dermal γδ T cells in a lab and then get them to produce lots of FGF-9 in order to inject them into patient's scalp.
This is a very recent finding...I really doubt they would have conducted a Phase 2 trial on this stuff back in 2010, but I may be wrongComment
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No they dont, they're just not discussing in any detail their human trials, they wont even tell people where they're being conducted, here:Hmmm, Hariri all those 3 links use the Nature Medicine article as their reference!
They also mention that these new findings were conducted in mice...they still need to conduct a small human trial to test for efficacy!
So the first step is to culture dermal γδ T cells in a lab and then get them to produce lots of FGF-9 in order to inject them into patient's scalp.
This is a very recent finding...I really doubt they would have conducted a Phase 2 trial on this stuff back in 2010, but I may be wrong
I really hope this sends a clear message to Aderans, because it looks like any moment Follica could come out with something which will make Aderans' decade long research agenda completely pointless. Oh well, that's what you get for dragging your feet and keeping your future customers in limbo for all these years.
Xconomy:
Follica said in its statement that it has already done preclinical tests that combine devices it has created to disrupt the skin with several unspecified “known and novel drugs.” It also claims to have run “a series” of human clinical trials, including a mid-stage study that has caused new hair follicles to be produced in humans. Unfortunately for our rabid readers, however, Olle and Follica aren’t offering many details from these studies, other than to indicate that the platform is proving to work so far and that the research has paved the way for the company’s next step: to try a specific device configuration with a specific, well-known and studied drug (meaning it wouldn’t have to be as extensively tested as a new chemical) in a group of human patients.
“We’ve been able to consistently show that we create substantial new hair follicles in humans, and that’s something that no other approach in hair loss as far as I am aware has been able to achieve,” Olle says. “That’s a critical step. The goal of some of those early trials has been to test the hypothesis of the mechanism that we had seen in mice.”
To the poster before who stated this wouldnt help as the new hair would still be vulnerable to DHT, well there's an obvious procedure that would benefit from a discovery like this. If the scalp requires wounding and then an application of a certain agent to induce neogenesis then clearly, a set of 3 hair transplant sessions with 4000 grafts each should become a norm with 100% donor regeneration. A finding like this would extend the work of Dr Gho to 100% full donor regeneration and a true limitless supply of grafts that are all DHT resistant.Comment
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OK, a good friend just forwarded the Nature article to me!
This was definitely a mouse study! But here's the interesting part, when they used Doxycycline on the mice, the amount of FGF-9 expression increased by 150-fold!
Maybe this is the novel therapy Follica is going to experiment with now! Wounding + Doxycyline!
Just a thoughtComment
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UK I don't know when xconomy edited their article, but they just added this in there:
[An earlier version of this story indicated that Follica used that protein, Fgf9, in its clinical trial. Olle later clarified that the protein, Fgf9, has only been involved in Follica's preclinical work so far].
So, FGF-9 never made it to human trials! It was being used in their pre-clinical studies prior to their Phae I/II trials (i.e. they only tested it in mice)...
That's OK though! They're onto something for sureComment
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