New Puretech Article Mentions Follica

[Noisette]

They seem to have the simpliest method (wounding and possibly minoxidil) and it takes this long to get a trial started? Tsuji will have his work done before these jokers get out of the starting gate.

" "Developing products to generate new human hair follicles and hair. Clinical stage, expected to enter FDA pivotal/registration studies in the first half of 2017."

" Follica is a clinical stage business utilising its regenerative biology platform technology to develop a novel treatment for hair loss. Follica's technology employs a technique designed to stimulate the growth of new follicles and hair through disruption of the skin, followed by treatment with drugs and chemicals to enhance the effect on these new hair follicles and potentially further develop new hair. Follica has completed three human clinical studies of patients with androgenetic alopecia to demonstrate hair growth and new hair follicle formation following application of its technology. Follica has also performed and funded preclinical work which, together with research from the University of Pennsylvania, serve as the foundational observations on which the technology is based. Follica plans to initiate a registration study in the second half of 2016, with data read-out in 2017. If the data are favourable, Follica would potentially plan to seek FDA clearance in 2017, with commercial release to follow as soon as 2018 ".

It's not really that simple because Follica have different products, and this is not a simpliest method as we can think Maybe Follica expected to enter different clinical trials as a pivotal study (for the different drugs and chemicals?) and another one is called registration study (a study before the release of their device and maybe one of their drug )

 

[champpy]

" "Developing products to generate new human hair follicles and hair. Clinical stage, expected to enter FDA pivotal/registration studies in the first half of 2017."

" Follica is a clinical stage business utilising its regenerative biology platform technology to develop a novel treatment for hair loss. Follica's technology employs a technique designed to stimulate the growth of new follicles and hair through disruption of the skin, followed by treatment with drugs and chemicals to enhance the effect on these new hair follicles and potentially further develop new hair. Follica has completed three human clinical studies of patients with androgenetic alopecia to demonstrate hair growth and new hair follicle formation following application of its technology. Follica has also performed and funded preclinical work which, together with research from the University of Pennsylvania, serve as the foundational observations on which the technology is based. Follica plans to initiate a registration study in the second half of 2016, with data read-out in 2017. If the data are favourable, Follica would potentially plan to seek FDA clearance in 2017, with commercial release to follow as soon as 2018 ".

It's not really that simple because Follica have different products, and this is not a simpliest method as we can think Maybe Follica expected to enter different clinical trials as a pivotal study (for the different drugs and chemicals?) and another one is called registration study (a study before the release of their device and maybe one of their drug )

Maybe i am over simplifying it. I would LOVE if they had a compound that wasnt minoxidil, but something that worked differently than minoxidil. I could then understand why this is taking so long.

God, but if this does end up only being wounding + min.......
Makes me think they are still perfecting things and they still dont have the protocol down yet

 

[Mach]

I thought I read before the product was already in the market. So it's something available now. I also thought this will be a home treatment. I don't think a home treatment would be intense wounding like BBQ man. The treatment has to be idiot proof.

 

[champpy]

I thought I read before the product was already in the market. So it's something available now. I also thought this will be a home treatment. I don't think a home treatment would be intense wounding like BBQ man. The treatment has to be idiot proof.

No its not out yet. People have been wounding for yrs, but not with follicas device. This wont be out till 2018 at the earliest

 

[Mach]

No its not out yet. People have been wounding for yrs, but not with follicas device. This wont be out till 2018 at the earliest

I was off on my message. I the chemicals follica used are already FDA approved or known drugs from other companies like Johnson and johnson (rogaine) or maybe setipiprant (allergan). Here's an old quote.
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.”
http://www.xconomy.com/boston/2013/06/03/hair-raising-follica-study-could-point-to-baldness-therapy/

https://clinicaltrials.gov/ct2/show/NCT02781311
Has anyone signed up fir the setipiprant trail?

 

[Swoop]

I was off on my message. I the chemicals follica used are already FDA approved or known drugs from other companies like Johnson and johnson (rogaine) or maybe setipiprant (allergan). Here's an old quote.
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.”
http://www.xconomy.com/boston/2013/06/03/hair-raising-follica-study-could-point-to-baldness-therapy/

https://clinicaltrials.gov/ct2/show/NCT02781311
Has anyone signed up fir the setipiprant trail?

Setipiprant isn't an option for Follica. It hasn't reached phase 3 yet and even if it will reach commercialization (highly likely won't) Follica would need to pull out the money for Allergan to come to a possible agreement. It's still a patented molecule.

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.

It's pretty simple; It's probably going to be either minoxidil or a PGF2a analogue (like latanoprost). Both off patent. They have already tried a GSK3B inhibitor and that didn't meet their expectations.

 

[NewUser]

In this article from 2013, it says Follica was in pre-clinical stage testing the device along with a number of known and novel drugs. Novel and NCE mean new drugs or molecules. And it sounds like they were and perhaps still are interested in boosting FGF9, a protein Cotsarelis discovered increases in the scalp immediately before follicle neogenesis.

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.

Are there currently any approved drugs which upregulate fgf9? PGE2?

 

[Tracksterderm]

In this article from 2013, it says Follica was in pre-clinical stage testing the device along with a number of known and novel drugs. Novel and NCE mean new drugs or molecules. And it sounds like they were and perhaps still are interested in boosting FGF9, a protein Cotsarelis discovered increases in the scalp immediately before follicle neogenesis.



Are there currently any approved drugs which upregulate fgf9? PGE2?

Sounds good in some ways to upregulate FGF9, but it also sounds scary.

http://www.ncbi.nlm.nih.gov/gene/2254

The protein encoded by this gene is a member of the fibroblast growth factor (FGF) family. FGF family members possess broad mitogenic and cell survival activities, and are involved in a variety of biological processes, including embryonic development, cell growth, morphogenesis, tissue repair, tumor growth and invasion. This protein was isolated as a secreted factor that exhibits a growth-stimulating effect on cultured glial cells. In nervous system, this protein is produced mainly by neurons and may be important for glial cell development. Expression of the mouse homolog of this gene was found to be dependent on Sonic hedgehog (Shh) signaling. Mice lacking the homolog gene displayed a male-to-female sex reversal phenotype, which suggested a role in testicular embryogenesis. [provided by RefSeq, Jul 2008]

 

[NewUser]

Yes it sounds like FGF9 affects WnT signalling pathway which apparently can also affect tumor growths through some molecular chain reaction. And yet Samumed announced "successful modulation of WnT pathway" recently. This is from Cotsarelis' paper in the journal, Nature:

Here we show that fibroblast growth factor 9 (Fgf9), initially secreted by γδ T cells, modulates hair follicle regeneration after wounding the skin of adult mice. Reducing Fgf9 expression decreases this wound-induced hair neogenesis (WIHN). Conversely, overexpression of Fgf9 results in a two- to threefold increase in the number of neogenic hair follicles. We found that Fgf9 from γδ T cells triggers Wnt expression and subsequent Wnt activation in wound fibroblasts. [...] The importance of Fgf9 in hair follicle regeneration suggests that it could be used therapeutically in humans.

In 2013 a Follica scientist claimed they are creating new hair follicles by skin "perturbation" and a few known and novel chemical entities(new drugs) applied topically.

Just as interesting, Christiano on JAK-inibs affecting WnT (2015):

Hair growth after JAK-STAT inhibition mimics normal anagen initiation by activating the Wnt and Shh signaling pathways

We know that JAK-inibs have a high success rate for growing hair in people suffering from autoimmune disorders: psoriasis and AA, AU and AT. I find it interesting that Cotsarelis' work on fgf9 overlaps immune disorder to a certain extent. Could it be that all hairloss disorders including Androgenetic Alopecia could be treated with a few drugs applied topically including JAK-inibs and perhaps a NCE which upregulates fgf9?

 

[NewUser]

They are a privately held company and company officials restricted from talking to news reporters. And, they listed on the London stock exchange. Is there a rule that says they must do clinical trials immediately in the US? Too, I don't think that advertising (and pumping-up stock shares for a quick sale) is Puretech's business plan. How many of us knew Follica was doing a phase 2a clinical trial in 2013?

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. (June 2013)

Lots of secrecy. I doubt they are creating new hair follicles with minoxidil but not ruling out the possibility perhaps if used with their new device for skin perturbation. Hair counts from the Indian study Swoop pointed us to are impressive by what I can tell. I think minoxidil would fall under the category of "known" but not a novel drug or new chemical entity, though.

 

[NewUser]

The more I see their device and the app, along with it more and more likely being bundled with minoxidil...I'm thinking what exactly is going to be the difference between what they do at the clinic sites, and what the stand alone device with minoxidil does differenty. We know the clinic is going to be for people more hard to treat cases as it was said in the documentation in the Follica thread I created, but I really am at a loss. I also am wondering if minoxidil would have to be used indefinitely. Since the wounding is creating the new hairs and minoxidil is just making them terminal, but would it be the same as just applying minoxidil on miniaturized hair. I am inclined to think no, since miniaturized hair has already been damaged by dht where as a new hair hasn't been exposed to the years of dht damage. Thoughts?

I read, I think it was the xconomy article from 2013, a doctor, and using Follica's patented device, will do the initial skin perturbation and perhaps use a mild anesthetic beforehand. Then they will apply a special topical in the first visit. But everything after that will be done by the patient at home using the smart phone app and perhaps applying min at key time intervals? Speculation after reading the 2013 xconomy article.

And if it is only minoxidil, then they plan to waste a lot of expensive doctors' time because anybody can squirt that stuff on their scalps. They've been doing clinical trials going on 4 years now, and I suspect they will include a new and "novel" drug in the formula.

 

[Blackber]

I read, I think it was the xconomy article from 2013, that a doctor will do the initial skin perturbation and perhaps use a mild anesthetic beforehand. Then they will apply a special topical in the first visit. But everything after that will be done by the patient at home using the device and smart phone app apparently.

And if it is only minoxidil, then they plan to waste a lot of expensive doctors' time because anybody can squirt that stuff on their scalps. They've been doing clinical trials going on 4 years now, and I suspect they will include a new and "novel" drug in the formula.

If what you say is true they wouldn't be wasting the doctor's time, they'd be wasting our money and making easy billable hours for the doctors.

 

[NewUser]

If what you say is true they wouldn't be wasting the doctor's time, they'd be wasting our money and making easy billable hours for the doctors.

Ya doctors and insurance companies are money-hungry for sure. Insurance companies won't pay for expensive drugs used off label, like Xeljanz and tofacitinib not approved for AA, AU & AT. Not yet, anyway.

What this would lead to, in theory, is a hair-raising procedure: a doctor would use a device specifically created by Follica to remove the top layers of the skin in a targeted area of hair loss. (Olle says the procedure isn’t painful, but the area could be numbed anyway.) While the skin is in this state, the doctor would then apply a drug. Olle declined to specify what type of drug this would be, whether that drug would contain fgf9, or if the procedure/drug combination would induce the body to produce fgf9 on its own.

I think it will be a "novel" new chemical entity which may be a protein called Fgf9 or perhaps a drug which induces your scalp's own production of Fgf9. If so, they probably wont be letting the drug circulate publicly outside of the clinical setting because generic drug producers and kitchen sink chemists will be mixing up batches of the stuff even sooner. But I don't think it will take a doctor to slather minoxidil on someone's scalp. Doctor or dermatologist will probaby use Follica's patented device for removing top layers of skin and then apply a topical drug. I'm guessing the smart phone app and maybe minoxidil would be part of the patient's own followup treatment.