Follica European Trials

[crafter]

no way are they on phase 2 or 3! they're not registrered on Clinical Trials.gov, a trial like that would mean 100s of participants, there would be some info on it, like recruitment info.

[crafter]

http://www.the-scientist.com/?articles.view/articleNo/37149/title/A-Hair-Raising-Solution-/

[locke999]

For a guy that slams speculation, you sure do it a LOT yourself.

Are you stupid?

The only thing I said is stop speculating and throwing it off as fact.

Link reads "there was a patent in 2010."
Post says "they are done with phase 2 will come out with a cure in 2015."

Stop arguing just to win an argument. Let it ****ing go.

I only threw counter speculation to make a point that anything could have happened, and that you guys always come to overly optimistic conclusions based on so little information.

You find a dermaroller article and start touting that dermarolling is the cure we are so close forget follica forget hair loss industry.
You read a CB article and then start touting CB is better than finasteride.

I applaud your enthusiasm to be proactive but you always cling onto every new bit of information that you found on page 203 of google results after searching "hair loss cure".

Get that chip off your shoulders, this isn't some hair loss crusade and you aren't the captain.

[HairBane]

Are you stupid?

The only thing I said is stop speculating and throwing it off as fact.

Link reads "there was a patent in 2010."
Post says "they are done with phase 2 will come out with a cure in 2015."

Stop arguing just to win an argument. Let it ****ing go.

I only threw counter speculation to make a point that anything could have happened, and that you guys always come to overly optimistic conclusions based on so little information.

You find a dermaroller article and start touting that dermarolling is the cure we are so close forget follica forget hair loss industry.
You read a CB article and then start touting CB is better than finasteride.

I applaud your enthusiasm to be proactive but you always cling onto every new bit of information that you found on page 203 of google results after searching "hair loss cure".

Get that chip off your shoulders, this isn't some hair loss crusade and you aren't the captain.

Ooh. Everyone do what this guy says, he's clearly a badass.

Anyway, you're too pessimistic and some people are too optimistic. The reality is that it's probably somewhere in the middle. They appear to be finished with phase 2, which is good news and something not many people here knew, so we're happy and it means they're closer than we thought to releasing a product. Don't get your knickers in a twist over people being 'overly optimistic', when you're just as guilty of the reverse. Get that chip off your shoulder.

[shredder]

no way are they on phase 2 or 3! they're not registrered on Clinical Trials.gov, a trial like that would mean 100s of participants, there would be some info on it, like recruitment info.

why should they be on both clinicaltrials.gov and clinicaltrialsregister.eu? One of them is sufficient, both sites serve the same purpose.

[Sogeking]

"A Study to Explore the Effect of Controlled Cutaneous Perturbation and Pharmacologic Modulation for Inducing Follicular Neogenesis"
Where does it say they have been testing this with PGD2 or FGF-9? This might be phase 2 which is over, but it might not be different at all from the dermarolling community trial being done by forum members. And we know how effective that is. We are missing some component, growth factors, or gene activators (basically we might need a specific gene more expressed) to turn velus hair to terminal hair. So we might expect the same results from this trails as well.

I apologize for playing the devils advocate here, but someone has to.

[Knockin on NW4]

"A Study to Explore the Effect of Controlled Cutaneous Perturbation and Pharmacologic Modulation for Inducing Follicular Neogenesis"
Where does it say they have been testing this with PGD2 or FGF-9? This might be phase 2 which is over, but it might not be different at all from the dermarolling community trial being done by forum members. And we know how effective that is. We are missing some component, growth factors, or gene activators (basically we might need a specific gene more expressed) to turn velus hair to terminal hair. So we might expect the same results from this trails as well.

I apologize for playing the devils advocate here, but someone has to.

Don't naively compare derm rolling to derm abrasion. DA actually removes about 3mm of flesh. Were as rolling just puts little holes here and there. Your comparing a bb gun to a bazooka

[brunobald]

The trials state they are using lithium gluconate @ 8% post wounding so that is something dermarolling plus minox does not do.

From what I can gather they are surface wounding and then applying the lithium gluconate in bald areas. After a few weeks they take a 4mm punch biopsy of the skin and count the follicules.

The part I am interested in is this... After they have taken a 4mm punch biopsy this 4mm hole in the skin become a new test wound site and they fill it again with lithium gluconate, wait and then take a new biopsy in the exact same site weeks later. Because this has previously been harvested this skin should be void of follicules. If there are any new follicule they have been born out of the skin regenerating to close the 4mm wound.

[Knockin on NW4]

and i quote

Although Follica has released few details on their proprietary procedure, the general idea is clear: their patented minimally invasive “skin perturbation” device removes the top layers of skin, causing the underlying skin cells to revert to a stem-like state, after which a molecule is applied topically to direct the formation of new hair follicles.

Indeed, Follica has already done preclinical and clinical trials, says Olle, “all of which confirm that we can consistently create new hair follicles in mice and in humans. As far as I know, no other approach has been able to achieve that.”

what part of consistently create new follicles in humans dont u guys understand? they didnt say maybe, or sometimes in the murine model... and the drugs being used are already fda approved. this will expedite the entire process.

this isnt skimming the bottom of the internet in desperation. this is a real cutting edge/ future treament. but for some reason discussing this in the appropriate boards irritates some members. Wow guys, really?

[locke999]

and i quote

Although Follica has released few details on their proprietary procedure, the general idea is clear: their patented minimally invasive “skin perturbation” device removes the top layers of skin, causing the underlying skin cells to revert to a stem-like state, after which a molecule is applied topically to direct the formation of new hair follicles.

Indeed, Follica has already done preclinical and clinical trials, says Olle, “all of which confirm that we can consistently create new hair follicles in mice and in humans. As far as I know, no other approach has been able to achieve that.”

what part of consistently create new follicles in humans dont u guys understand? they didnt say maybe, or sometimes in the murine model... and the drugs being used are already fda approved. this will expedite the entire process.

this isnt skimming the bottom of the internet in desperation. this is a real cutting edge/ future treament. but for some reason discussing this in the appropriate boards irritates some members. Wow guys, really?

Here's the thing. They say they have consistently grown new follicle, but that doesn't state the density that it will grow at. It could be that they grew new follicles that wouldn't make a cosmetic difference that hair loss sufferers would be happy with. Making new follicles in itself is a step towards the right step and I am very happy about that.

But members go above and beyond the information given and jump to conclusion that they are almost done and will release a procedure in 2015.

These clinical trials may proves that they can make new hair follicles via damaging the skin but it doesn't mean that they have optimized it into a procedure that would "cure" hair loss, which would require another set of clinical trials.

[Joker]

Just chiming in real quick.

This trial was discovered and discussed quite a long time ago on a different forum.

When the most recent Follica press release says they initiated pre-clinical and clinical trials, this is clearly what they were talking about (in addition to an introductory trial they conducted at Harvard wherein absolutely no chemical elements were applied to wounded skin).

Like most things Follica does, the timing of this trial, the discovery of Fgf-9 and the most recent press release make absolutely no sense when viewed together.

The Wnt/wounding thing was discovered in '06 and talked about in '07. The Fgf-9 thing was discovered in '09, patented in '11 and talked about in '13. Meanwhile, a European trial was commenced in '10 and completed in '11. Then from '11 to '13 it looked like the company dropped tons of employees. Now, in '13, they are saying that the Fgf-9 discovery merits a new clinical trial. If that's true, why didn't the '10 trial include Fgf-9? After all, Cotsarelis made the discovery year earlier.

The statements about "consistent, significant hair follicles" are meaningless because if that was true, they would have pursued Phase 3 immediately and wouldn't have needed Fgf-9. Evidently, there was a problem with their results that forced a cessation of the company's productivity from 2011-2013. Hopefully that problem is fixed by Fgf-9 and will be tested soon.

Likely, it will take them many years to institute and then many more years to run this new clinical trial. I'm not saying it HAS to take a long time, but given Follica's track record (6 years to Phase 2 with drugs and devices that have been approved since before the inception of the company), I'm guessing it WILL. Now that companies like Aderans have failed, I'm also guessing Follica will approach the clinical translation of this technology with even less haste than it has in the past.

Also, this is a good read: http://www.nature.com/nm/journal/v19...l/nm.3181.html

[Joker]

A hopeful hypothesis (because I've been having a bad day otherwise):

Follica might have dropped employees because it is outsourcing the day-to-day research to a large pharma partner.

It might have delayed the transmission of its Fgf-9 discovery until it was closer to releasing a product.

Phase 2b, which includes Fgf-9, might be just around the corner, with a seamless transition to Phase 3 if successful.

A more likely hypothesis:

Follica is a hopelessly opaque company that will continue to obscure its meager progress for several years before announcing another study that brings them "really close" to another variant of a solution we've already waited too long to receive.

This is why Dr. Wesley's research - which, assuming the FDA doesn't step in the way last-minute, is much closer to fruition - is so important. It's not "perfect," but it could potentially create great results for most guys with hair loss.

One theory I had w/ re: Pilofocus that I think is hopeful is the following:

We know that Artista says there has been significant regeneration on several patients.

We also know that Dr. Wesley has done exhaustive survival studies of transplanted grafts that prove they grow really well in the recipient area.

Putting these things together, we might have established that Pilofocus really does accomplish a "true" donor increase. I guess we'll have to wait and see.

[crafter]

why haven't follica done any presentations like Histo and replicel? or released any data, photos etc?

[Sogeking]

You guys are grasping straws here. The experiment about adding lithium gluconate with derma abrasion was the first testing Follica did, even before PGD2 and FGF-9. It was known on ************ a year and half ago, however it was being done in silence. So the trials with PGD2 and FGF-9 haven't even started yet as said before about Follica. I am sorry guys, I really am, but they've been testing this lithium thing for years now, I don't think it will pan out...

The thing about lithium being good to kick start follicle neogenesis is an old thing, I mean TRX2 is basically lithium...

[HairBane]

You guys are grasping straws here. The experiment about adding lithium gluconate with derma abrasion was the first testing Follica did, even before PGD2 and FGF-9. It was known on ************ a year and half ago, however it was being done in silence. So the trials with PGD2 and FGF-9 haven't even started yet as said before about Follica. I am sorry guys, I really am, but they've been testing this lithium thing for years now, I don't think it will pan out...

The thing about lithium being good to kick start follicle neogenesis is an old thing, I mean TRX2 is basically lithium...

Pure conjecture, no one knows. Let's wait and see