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Hair-Raising Follica Study Could Point to Baldness Therapy

Xconomy Boston — 

[Updated, 11:00 am ET] Few stories have struck a chord with Xconomy’s readership quite like that of Follica, the PureTech Ventures-incubated startup founded in 2006 with plans to combat male and female pattern baldness by using adult stem cells to grow new hair follicles. Unfortunately, details regarding Follica’s science—let alone its clinical progress—have been as tough to spot as a good toupee.

Boston-based Follica and the man behind its technology—University of Pennsylvania stem cell biologist George Cotsarelis— at least partially lifted the lid (or wig?) on those secrets today with two announcements: First, a research team led by Cotsarelis has identified a key protein that could potentially be used therapeutically to help people grow new hair follicles; Cotsarelis has published the results of that study in Nature Medicine. Secondly, Follica claims to have used its technology in a procedure that successfully grew new hair follicles in humans in a clinical trial. [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].

Even so, a number of questions remain. Follica provided little else in terms of specifics—for example, how many people are in the trials, where they took place, the extent of those results, exactly what its next study will look like, or roughly how long it will take for these findings to turn into a real live procedure sold on the market. It is similarly evasive as to the details of the procedure it is devising.

“We’ve had to be careful about how we deliver the news because there’s all these huge responses,” says Follica co-founder and PureTech principal Bernat Olle.

For those new to the Follica story, here’s the synopsis: Research that Cotsarelis conducted at his lab at Penn showed that new hair follicles would form at the center of some skin wounds. The general concept is that when the top layers of the skin are removed, the skin cells underneath are essentially in a primitive, embryonic state at which they can form new skin, new hair follicles, and ultimately new hair. Follica’s quest has been to devise a procedure-drug combination to take advantage of that window of time and direct the cells to form new hair follicles.

Now Cotsarelis appears to have found the catalyst that could potentially turn that idea into a treatment. Cotsarelis and his team have homed in on a protein known as fibroblast growth factor 9, or Fgf9, that they believe to be implicated in the growth of hair follicles. Fgf9—which is found in short supply in humans, according to Olle—is part of a family of proteins formed by cells in the skin that perform a variety of biological functions such as wound healing. The researchers found in the study that cells produce a lot of Fgf9 right before a new hair follicle forms on a layer of skin. So by increasing Fgf9 while the skin is regenerating, researchers could potentially direct the skin to form new hair follicles.

“It draws a very clear link between tissue regeneration and the skin immune system,” Olle says. “It opens the way to therapeutically intervene in humans with the approach.”

Follica’s idea, then, is to use its proprietary devices—around which Olle says the company has a broad group of patents—to induce this process to occur, and then add Fgf9. 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. He did say, though, that the company has been doing a lot of work with topical formulations that are applied directly to the skin.

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 crate 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.”

Follica would still have to determine in longer trials and follow-ups with patients, for example, how long the new hair lasts so as to know if patients would have to get another procedure down the road.

Olle and PureTech managing partner Daphne Zohar co-founded Follica in late 2006 along with Cotsarelis, Harvard Medical School dermatologist Rox Anderson, and Vera Price, the director of the University of California, San Francisco Hair Research Center. Kirk Raab, the former CEO of Genentech, is the company’s chairman. William Ju, a board certified dermatologist who formerly worked at Merck Research Laboratories, Pharmacia, and PTC Therapeutics, became CEO in May 2009. The company has raised $19 million in financing through two rounds since its inception, according to Olle.

The interest in Follica’s pursuit has been enormous at Xconomy. Put it this way: our last story was written in 2011 and it is still serving as a defacto message board on the topic. Some 2,000 comments have been posted. That, if nothing else, shows the intense interest surrounding the company’s work.

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  • McJ

    Thanks Xconomy! Knew you’d come through with some further info. This is definitely a positive step forwards. We’re all rooting for you Follica!

  • Artista

    Very Positive!! Thank you Xconomy once again.. Hey McJ i had posted your earlier Follica item here on the other Website

  • Nik

    Follica, my hopes are with you. Best of luck to you science heroes.

  • Shooter

    I honestly thought this research was dead. Not even going to lie. Having said that, I’m glad these guys are still moving along (albeit at a slower pace than initially anticipated). I hope they’ll let us know when we can sign up for future clinical trials! I believe very cautious optimism and a large dose of good luck is warranted. Our hopes are with you, Follica!

    • Curious

      Right there with you. Thought you were gone as well! Glad to see you’re still around for what it’s worth.

  • A

    Wow i truly thought this place was dead since i stopped posting in 2010.
    Here is some good news and hopefully we will know more soon

  • John

    Did they mention pdg2/gpr44 blockers in their clinical trials?

  • tk

    After the Histogen disapointment, what a pleasant surprise this is!

    The big question remains though: what is the density of the hair that was grown in humans? If it’s anything over 30 hairs per cm2, this could be a real cure.

    Not counting on it, but looks good nonetheless.

    Wow! Follica seems far from dead!

    • Curious

      Why was histogen a disappointment? They didn’t grow a full head of hair?

  • Aleluia

    They´re alive!!
    Very good news

  • Lurker

    I never lost the hope in these guys. Does anyone know what clinical stage they are in “officially” then?

  • herzog

    I’m happily eating crow right now, though it seems they havent run tests on this Fgf9. All their clinical tests thus far have been on WNT proteins. It seems Fgf9 is a more potent factor in hair loss, but their clinical trials will have to start fresh. Hopefully they can move quick as the drug in question is already approved for other usage.

  • Curious

    This the new place to keep the conversation going?

    • Hairmice

      Yeah i think it is. It´s cleaner than the older one

  • Lurker

    Herzog raises a very interesting and important point on clinical trials. I’m not certain he’s correct though that they need to start fresh. I remain confused on whether they have or have not begun clinical trials with Fgf9 and what stage. I admit ignorance to whether one would have to begin anew if they try a similar approach with a new compound (like Fgf9). But, these articles are confusing in that they “imply” they’ve begun trials (with Fgf9), where other articles (and discussions) seem to be talking about their old trials and they’ll need to start “fresh”. Bottom line – I’d like to know for certain whether they are in clinical trials and what stage from the company themselves. This seems to be a noteworthy question, which isn’t clear from these articles.

    • McJ

      This article was updated to clarify that point;

      ‘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.’

      To be perfectly honest there is no point in speculating how long or what stage they are at as they’re not going to tell us, certainly not in the near term.

      As many have admitted, most thought Follica dead and that was largely based on the fact that they were quiet. We can all start the idle speculation again based on assumptions or gut feelings or we can just let these folks work diligently and quietly in the shadows. When they’re ready to shed light on their work, they will. They’ve done it partially already and I’m confident that they’ll keep us informed when the time is right. These guys are professionals and more importantly they’ve got credibility. I’ll take diligent and quiet over shaky time-lines and even shakier claims.

      It’s the waiting game.and that kinda sucks but we’ve just heard some very positive news. Judging from the quotes from this article, they are serious about finding either a lasting or long term solution to hair loss. I’m sure there are more hurdles to come but I think we just have to have a little bit of faith in these guys.

      • Lurker

        Thanks for pointing that out. I didn’t see that. Although my gut probably sides with what you and Herzog are insinuating, my question isn’t completely answered though. My question is do they really have to start from scratch (clinically) based on the Fgf9 “inclusion”? Olle doesn’t really answer that. And I still believe it’s a relevant question, despite knowing they may not want to answer it.

        I do think there’s reason to “for us” (as sideline viewers) to try to answer this question: Does one “definitively” have to start from scratch if they add “one” new variable during clinical trials? I don’t know the answer. I assume the answer is yes, but the process will be quicker. If that’s the case, so be it That’s probably what you assume too. But, it’s an assumption and I was wondering if there were an people more experienced than I am who can more concretely answer the question.

        As for your other comments, I’ve been involved in this forum on Follica pretty much since day 1 – over half a decade ago. Like others who have done the same, I wouldn’t have kept coming back to search for them here and elsewhere had I not “had a little bit of faith in these guys”. I sincerely thought they were the answer simply because Cots was involved with them. They made a goal of getting something to market about 5 years after they began. That’s ironically, right about now. Since then, however, Cots has come up with independent research, that to me was great, but a little concerning regarding his linkage with Follica. This provides more proof, he’s still on board in 2013 and they’re not dead. It’s great news. But, greedy soul that I am – sure, I do want to know more if I can. So, now, it’s about 5 years later from Follica’s birth, give or take. Where does this thing stand exactly in terms of when it could be introduced – 5 more years? Less? I understand there are hurdles with the FDA and I also understand we know very, very little of the inner workings within the company. We don’t know what they know. For all we know, this is all part of their market strategy. Maybe they are in clinical trials approaching stage III or IV with this?

        Asking a question isn’t uncovering a mass secret that could sink the company. If it’s a dumb question, so be it. I can handle that. But, to me, it seems like it’s a worthwhile question. Do they definitively need to start at Stage I? I don’t know that quote answers the question.

        • herzog

          It sounds like they know exactly what they’re doing. It sounds like preclinical studies with Fgf9 had the desired effect and grew hair. They have their abrasion technology patented and ready to go. They now just need to go through the proper regulatory channels.

          Phase I will be a small study to prove safety and proof of concept. Phase II will recruit a lot more people to get the dosage right and check efficacy. Those back to back should take at least 2 years. Phase III usually takes the longest, which is regulatory approval from the FDA. However, if the drug they test is already proven safe and used for other purposes then we could get a fast track. My hopeful estimate is 3 years, but we are more than likely back into that old “five year” cliche.

          That said, things look promising. Just a waiting game, as McJ said.

          • Lurker

            Yeh. I guess I’m just confused on why the ‘past five years’ gets tossed out. I mean the article above says “Follica claims to have used its technology in a procedure that successfully grew new hair follicles in a humans in a clinical trial”. Of course, then they go on to say that Fgf9 was not used in that trial. But, later they hint that Fgf9 may not be “used” it may be created by something else. Later, they talk about a drug that’s already passed regulations as the new variable. So, still, I remain confused as to why several of you are so certain they “start from scratch” via trials. It seems they did a lot already with the technique. Now, maybe they try a new compound with the technique. But, maybe they don’t? Maybe their just publishing findings, which will be referred back to post market- intro. Another important quote is “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.” – Yet, they start at Stage 1? I honestly think Follica may be careful about revealing info on timelines for several reasons, some other than monetary. For example, they may be concerned that some idiots will try to do what they are doing themselves and harm themselves. I mean, just go to hairlosstalk to see this behavior in action. So, maybe they are kinda saying – “hey guys, we know you’re desperate, but don’t put Fgf9 on your head. You’re not Doctors “. Also, maybe they don’t want to say it, but Fgf9 isn’t exogenous, it’s endogenous? Maybe the endogeneity and the drug that’s mentioned will make the drug obvious. If that’s true, this thing maybe close to market already. This is just part of why I’m confused. Oh well, I should probably just shut my yap and get use to it. ;)

        • McJ

          Oh, hey man I’m with ya – I’d love to know more about timelines from Follica. I’d love way more answers. The ‘When will we get this’ part still nags at me.

          And it certainly wasn’t a dumb question and I wasn’t trying to imply that but I was speaking more broadly about those sort of questions. There’s a guy (or gal, I’m not sure) called ‘disappointed’ who seems to have a good inside knowledge of biotech. He’d be the one to give a reasonably knowledgeable answer.

          It’s just at times, really judging from the last board, that people – and I include myself in this – get carried away with emotion and start spouting dumb speculation. I can see Follica going quiet again for a year and folks start saying ‘Follica are dead’ again. That gets annoying but I get why folks do that and it’s just pure frustration.

          The only thing I can add to the conversation at this point in time was what the author of the article pointed this out;

          ‘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.’

          That ‘extensively tested’ part would seem to hint that we wouldn’t have as long to wait. Maybe, if all goes well but that’s just slight informed speculation. It’s still speculation. They aint gonna tell us as you know but I’m getting to be ok with that because this latest announcement restored the faith – faith that had been wavering.

  • Lurker

    This patent is from 2009/2010. Open it up and search for Fgf9. They were using it then. http://www.freepatentsonline.com/WO2010056759A1.html

  • Curious

    Hey Lurker. So I just read through this long list and figured that not adding to the long tabs that you have to keep clicking regarding where Follica is at. As McJ said, let’s not get to speculating whether that be the timeline or the actual procedure.
    With that said, here is my opinion after watching these forums freak out at this type of news. My guess is that Follica failed with their last procedure and went back looking for ways to improve or where problems occurred. They found that this new Fgf9 was something that may be affecting the outcome so they tried it in pre-clinical trials (or some drug that affects it). My guess right now is with every “we have found the cure” is that it is in pre-clinical trials that still needs to pass through phase 1-3 before becoming commercialized.
    Let’s say that it is using a drug that is already being widely used for a different purpose. All that means is that the Phase 1 trials which deal with safety will be easily passed as the drug already has been vetted for safety. What it doesn’t pass is phase 2 and 3 which are the longest parts of the trials and deal with efficacy. What we get with that is that we shave off a year of trial period at most (if the FDA says that a safety trial is not necessary). In the end, they still need to test efficacy to see if it is marketable.
    That said, I think that they really feel that they have something with this new treatment but really if all they have is a few patients that have responded well they still need to see if it works on a mass scale. I once read somewhere that a guy had burned the top of his head with some hot liquid or something like that and ended up growing back a significant amount of hair afterwards. I feel like that is still where we are at with Follica, we have a procedure that has worked for a few people but honestly… until I see some better data I won’t be pouring any hot liquids on my head, if you get my drift. Let’s hope Follica has some good stuff here but don’t take their ultra secret silence as a noble thing… they weren’t talking because their last trials failed. Now they have something new to talk about so they are talking… yet they don’t have a cure.

  • ZZ

    Some thoughts & observations:

    Timelines: We have seen many discoveries of pieces of the puzzle as as well as pre-clinical and early stage trials indicating possibilities of future success but we have never seen a “breakthru”. So any timeline projections based on these prospects have been little more than wishful thinking. Any timeline would have to include a period of time for actually finding an effective approach (the hard part) and then the requisite remaining time period for FDA approval (depending upon where you are in the trial process when you discover the “breakthur”). This may be the “breakthru” that allows us to legitimately start the timeline clock running. I base that on this quote by Olle: “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,” Emphasis on “consistent” and “substantial”.

    Explaining a Lot: We have all seen trial after trial that grew hair on mice but then failed in humans. We may now know why….. given that mice skin has cells that produce fgf9 whereas human skin is relatively lacking in these cells.

    Success w/o direct application of fgf9: It is hard to know the exact details but from a reading of the article above, it sounds like the “consistent” and “substantial” quote is based on trials using a compound other than fgf9 since they say that fgf9 has only been used pre-clinical to date. Therefore, it is possible that Follica could proceed on 2 parallel paths, one with the compound that has already been tested and a theoretical quicker path to market; and the other with fgf9.

    fgf9: I have not yet been able to google research as to the safety of fgf9 or whether it has already been FDA approved for certain uses. Given that fgf9 proliferates cell growth, I would think it would draw close scrutiny by the FDA with respect to unintended cell growth possibilities. No knowledge here, just asking the question. It would be great if knowledgeable people in this area could weigh in.

    Parallel Paths: If Follica is confident of safety and effectiveness, it is possible that they could run Phase II and Phase III trials concurrently. This has been done in the past resulting in FDA approval.

    • Lurker

      Interesting take. Thanks for that.

      One additional point – this ‘article’ quote is also important: “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.”

      I sincerely believe they are trying to get around having to ‘start over’. That said, like everyone has reiterated, there’s no need to jump up and down over this. It’s a good first step, but we’re all to use to failure.

      • ZZ

        Great point Lurker……………..so it definitely looks like they will be pursing an avenue with a potential faster track. It would appear that they are also going to test a protocol (that may be more robust) with fgf9 since they have already completed a pre-clinical test. Only time will tell what it all means but it certainly sounds as positive as anything I have seen yet.

    • Curious

      ZZ, great look on things. I think people are getting a little too excited about skipping processes and rushing the timeline. I know we want to have this product today and have it work as they say it will with “consistent and substantial new hair follicles” but I think everyone should keep their pants on. Gathering information is the best thing we can do now regarding where they are at but as McJ said below the only fgf9 studies that they have done were preclinical. Let’s hope they found the “breakthrough” as ZZ puts it but as he also says they still need to continue on the FDA timeline for wherever they are (preclinical studies at this point). Undoubtedly they will try streamline the process if they know they have a solution that works and works well but that is the best they can do… they can’t just jump that process because they have other trials for other methods going on. For example, Latisse had their eyelash growing treatment already approved… they still had to go through all of the normal trials with the FDA which turned out good because they found that the treatment doesn’t work as well, if at all (I don’t remember), for the head. Can you imagine if these guys started to market this and the backlash that would have happened if they would have just assumed? This trials are set up to stop that from happening. If you add one new chemical to the procedure it will have to go through all phases again guys… that’s just common sense. All data collected before that is irrelevant now. THE GOOD NEWS: consistent and substantial new hair follicles! But again, take that with a grain of salt. As much as I want this to be the breakthrough as ZZ puts it, the rhetoric sounds very similar about many other preclinical treatments that have came with big noise around them and quietly faded away with time once in trials. Either way, cheers to the good news!

      • Lurker

        I respect your opinion… but,… you think they’ve know about this enough to publish about fgf9 into 2010, yet, they never conducted studies with it? Really?

        P.S. I get the whole – don’t get too excited theme when you’re looking out for someone’s welfare (guarding them against a let down). But, I think it’s gotten a bit too close to patronizing (“let’s not do get to speculating”, or that’s just “common sense”), which is a bit harsh. I’d suggest you tone that down a bit.

        • Curious

          My apologies if you find what I wrote patronizing, that wasn’t my intention.

          I do think that they have done studies but only the studies that they have said they have done which have been preclinical studies. I mean no harm when I say this will still need to go through clinical trials which means time. I truly hope that this works and I’m on the same page as everyone with the sooner the beter.

          I think that we tend to get carried away and like to read into things that aren’t there. I’m trying to balance the conversation out as it tends to go on these roller coaster rides as news articles come out. On the opposite end, when people start to say things like we are screwed and that there is no hope I try to put a non-patronizing “common sense” into why we aren’t screwed and why there is a ton of hope. Let’s take the news that comes to us with strides and hope for the best. I’ll be the first to admit that I am wrong if Follica is already in Phase 1,2 or 3 when they say they are but right now all I have heard from them is that they have only done preclinical studies. I’m not one to sit and dwell on the good or bad but what we have today is very exciting and I’m in the same spot as everyone, hoping that they have found something big.

          • Lurker

            Well, there’s a lot of assuming going on, by everyone (you, me, author of the article), which admittedly is problematic. These guys aren’t exactly open and have never been. I’ve been watching this at this source alone for over half a decade and I wouldn’t be slightly surprised if they “don’t need an additional study” or “do need one”. My issue with your assumption is your 100% assuming the fgf9 is endogenous. And that’s an assumption. It could be created exogenously. I’m not sure. Moreover, I’m not sure it hasn’t even been used considering they mentioned it in a patent before the trial “we have on file”. Truth be told – they may need to start from scratch. I don’t know. I don’t know much other than the very promising, but absolutely confusing article posted above, and neither do you. Hence, why the question… “what particular stage are they in”? …which you were kinda implying we shouldn’t ask in posts below (which kinda started this dialogue)… is actually quite relevant. It’s worthwhile question and doesn’t really need a “hush, hush”. In fact, it would be good for everyone (me, you and all readers) to get it answered.

          • Curious

            Hey Lurker,

            I think you’ve gotten me all wrong. I’m not trying to hush anyone and agree with you in regards to that we don’t know much (kind of a Follica trademark).

            As far as exo/endogenously I have made no claims and could care less. If it works, it works whether we add it from the outside or it is induced from the inside as long as it is safe. I’ve never made a claim for either and have no science, article or even educated guess to suggest either.

            Here is my point, again: I’m not sure why they are announcing it right now but my understanding of this article and past news/ trials is that this, fgf9, was not included in their previous trials. I’ve not read anything in regards to their clinical trials that focuses on fgf9 but if you could point me to a source that does mention that they were testing this in trials (outside of just having a patent for it), I would happily admit that I am wrong and have more hope for this solution as they are surely one step closer. As I see it, if they are adding in a new substance (either fgf9 or something to induce fgf9) into the trial they will need to start from Phase 1. As ZZ mentioned above, once we have the “breakthrough” is really when we can start the timer for FDA trials because until we have the breakthrough it is just putting a timer on something that may not be effective. I’m not 100% convinced we have the “breakthrough” here (as we have been taken for rides before) but I am definitely excited by the news and hope that this is what we’ve been hoping for.

            With that said, I’m going to politely remove myself from the conversation as I feel that you may have completely misunderstood me from the beginning. You seem to be having a conversation with me that I’m not part of.

          • Lurker

            At the end of the day, I want to know what stage they are in or will be. That’s all. I get frustrated when I come to a forum of like-minded people and hear “let’s not” do this or that (like ask questions on timelines). I think to myself – ummm, why? They didn’t tell us the timeline. I’ve been here just as long as you, I know let downs, but…. of course we want to know the timeline!

            On exogeneity or endogeneity, it’s important, considering we don’t know for sure the stage and we all want them to come to market quicker. If it’s endgenously created, that may hint to them being at further along as a new compound may not be needed for fgf9 to to be created “within” (hence, why start over?). If it’s exogenously created, you’re probably right they’d have to start at stage I. Yet, this is ALL confusing because of the patent I showed – which shows dates and clearly indicates they knew about fgf9 BEFORE their ‘confirmed’ trial. Are we sure they didn’t use it in the trial then?

            I don’t want to argue with anyone. We’re on the same team. What I want is for us to not argue on what we should or should not be discussing (hence the patronizing aspect). It’s a discussion forum. I believe timelines are important – I know I’m not alone. I understand we don’t want to get hopes up, but guess what – I’m here because my hopes are and have been up on Follica. Let’s get the question on staging answered if possible.

          • herzog

            Fgf9 has only been in pre-clinical tests. They told us plain as day. Any questions beyond that should be directed to Daphne Zohar’s twitter page.

          • Lurker

            Well, you’re right,,, but, that was stated after the fact – a revision. Which was a touch odd, but ok. However, then they go on to say they can grown new hair follicles and they’ve completed trials, including a mid-stage one. This leaves one scratching their head – so ummm… when did you grow the hairs? When/where did this happen? Then you got the patent (where fgf9 is mentioned all over it) that was published a year or so prior to their one trial to which we have information. And on top of that, perhaps when they clarified that Fgf9 was only used in pre-clinical testing, they meant to dampen the flame (hope)…. but were honest – literally,they hadn’t used Fgf9 “itself” outside of pre-clinical testing, but HAVE USED a drug that sparks Fgf9 already. Lots of confusion here, maybe there’s a purpose to it.

          • Curious

            Thank you herzog, that’s all I’ve been trying to say. I really don’t see anything beyond that. Otherwise I think they would have been explicit in saying”… but we have tested something that induces fgf9 in wounds.” That statement just never happened.

        • Curious

          PS. If you were wondering what clinical trials they have done so far as being recorded by some govt. agency : https://www.clinicaltrialsregister.eu/ctr-search/search?query=follica

          • Lurker

            PPS… if you were wondering that particular clinical trial began after the findings in the patent I posted below were published. That’s the patent by Follica that mentions fgf9 about a multitude of times in a “patent” they put together BEFORE the trial. Think about that.

  • André

    I just can’t wait for this to happen…that’s freedom from drugs that just doesn’t work…such a waste of money!!!!!

  • Aleluia

    Fgf9 will be the last follica´s discovery?
    Because first was the WNT protein, then the PGD2 and this one.
    I don´t care about hairy mices, i care about human hair!

    • herzog

      Was thinking the same thing. It’s turning into a circus.

    • Vikki

      Check out this quote again:
      “We’ve been able to consistently show that we crate 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.”
      They are actually claiming that they’ve got it WORKING in humans! This is great news!

      • Vikki

        I trust that they actually meant, “create”, as opposed to, “crate”. But hey, if they’re growing crate-loads of hair, then who cares about a typo? :D

  • Colt

    Sorry to jump in with this, but can this additional discovery be applied for hair removal as well? That has always been another focus for follica…

    • Vikki

      I’m not an expert at all, but I would have thought that, if up-regulating Fgf9 after skin disruption increases hair growth, then down-regulating Fgf9 at the same stage would discourage hair formation.
      Which, if true, would also be pretty exciting. (Maybe time to get rid of your Gillette shares…)

      • Colt

        Thanks Vikki- yes, there is definitely potential. I guess i just wonder if follica is actually pursuing the hair removal track alongside the hair growth one. They don’t seem to talk about it as much, although you’re right, the science would suggest it is certainly possible. I certainly hope that they are because that would be very significant!

  • Vikki

    I thought this quote was quite interesting:
    “Olle says the procedure isn’t painful, but the area could be numbed anyway.”

    This would suggest they have a fair amount of patient data in this regard, e.g. they performed the procedure on x number of patients, and x-n number of patients report it to be not painful.
    There’s also the possibility that Dr Olle has experienced this procedure for himself. I’m speculating wildly, of course, but he sounds confident.

    Also interesting was the fact that they claim to have run a series of human clinical trials, including this mid-stage one that’s produced de novo follicles.

    All in all, very exciting :)

    • McJ

      I agree. That was quite specific wasn’t it? We’re not quite at that break through moment yet I don’t think (I’ll be happy when I see some before and after pics) but judging from this article, we could be darn close.

      The only really bothersome part is having to wait for the next bit of news from them. But yeah, exciting.

  • John

    What would you people do? get a hair transplant or wait another couple of years? I am getting very desperate and dont want to make the wrong decision. Realistically how long do we have to wait? I have been following Follica since 2007 and this is the first time they release any news that makes me believe they are still working on a treatment.

    What happened to Histogen? are they still doing studies?

    • Curious

      If you’re waiting for “the cure” it isn’t going to come for awhile. There are treatments that are coming down the pipeline but really we can’t give any detail on those as the data that has been release is from preliminary trials, the data wasn’t completely impressive (although I thought it was good) and they haven’t followed up with any more news whether they are going to go into Phase 3. I think in October after the conference we will know more, not only about the treatments discussed here but also advances in HT (including wesley’s “scarless” surgery).

      The way I see HT’s is that it is definitely a last resort. Once you get a transplant, you will be investing in hair treatments for the rest of your life which will in turn be very costly. Real treatments are being tested and we will break the code soon… there is too much good research going into this that it will happen sooner than later (we will see new treatments that will advance the field within our lifetime, within the next 10 years). My question to you is how much do you trust in that? Can you buzz (maybe not slick) your head until that comes around. Are you okay looking at life as one big whole and not just focusing on the few years that you have to buzz your hair short?

      Once you’re cut you’re cut but I also see the treatments that are coming down the pipeline like this: pictures or it didn’t happen. If you don’t buy an HT you can invest the money in other parts of your life.

  • Troy

    Even if it generates a couple of hairs, they should release it now. Forget the FDA and even the USA for that matter, release the product in Africa or the Middle East and let people that want it that bad fly there.

  • McJ

    Bit of news/non-news – actually it depends what comes up down the line. Dr. Robert Langer now appears to be on the Follica team. Now, you may not have heard of him but he’s a pretty big name in the biotech field. This is his wikipedia page;


    Now that could be a big deal – but I don’t know in all honesty. But it certainly adds to the credibility. As a bit of a side note, the Follica site is currently down. Possibly getting a revamp with added info maybe? Or just a glitch?

    Anyway, I’ll repost this. I was initially shot down when I posted this on the last board and probably rightly so but in light of the recent news from Follica. I reckon it’s fairly salient;


    That guy used to be (and still could be but isn’t listed) on the Follica board, I wouldn’t be too shocked if we got some more info on Follica later this year.

  • Colt

    Thanks Vikki- yes, there is definitely potential. I guess i just wonder if follica is actually pursuing the hair removal track alongside the hair growth one. They don’t seem to talk about it as much, although you’re right, the science would suggest it is certainly possible. I certainly hope that they are because that would be very significant… it would be good to know either way, though. They have discussed hair removal in previous patents, which means it is still on their radar.

  • Sammy

    Hi all, i’m new to the forum. Colt, I am curious about the hair removal question. Anybody have any thoughts on it? I guess it is all speculation, but maybe others have some information or insight to add .

  • McJ

    I’m sort of glad it’s quieter here these days as it means most of us accept that Follica being quiet is par for the course and also just possibly, they could come through for a lot of people – folks looking hair and folks looking rid of unwanted hair. Just wanted to add a bit of further observation to this though.

    It’s been almost a month since the news broke – yet no major news outlets have picked up on the story. That’s kinda odd given the whole ‘ follicular neogenesis in humans for the first time’ thing.

    I know Xconomy added further info to the story (And by the way, thanks again Ben and co!) but the mainstream media loves a sensational headline, particularly regarding hair loss treatments or as they love to say ‘cure’. Is this because Follica haven’t contacted them or does it not work like that?

    Well, no major news outlets apart from The Wall Street Journal. The story appeared there. And a certain type of person, generally speaking, reads the WSJ. Is this possibly to gear up for more money or something else? I noticed in this Xconomy article that Olle said they had raised $19 million in funding. Yet the previous two rounds yieldled $5.5 million and $11 million. So did they quietly get 2.5 million from somewhere else? Would that maybe explain the addition of Gwill York from Lighthouse Capital Partners?

    Or I’m possibly reading too much into all this. Still, when Follica really landed on the radar in 2008, there was quite an explosion of interest and they hadn’t even tested on humans at that stage. Perhaps Follica are getting wiser in this regard and don’t want too much attention…yet!

    Just a few stray thoughts anyway. Hope everyone is hanging in there.

  • Jayson Jade

    Buy a hair clipper and shave it. It’s only hair, who cares?

  • tk

    It’s great that they could create “substancial hair”, but without a picture to show, this means very little as far as I am concerned. I mean, what density are we talking about here? Will it work on thin areas, bald areas?

    With the terrible state of hair loss treatments, “substancial” could very well only mean an increase of 20% in density, or something ridiculous like 10 new hairs per cm square.

    So allow me to be cautiously optimistic.

    Oh, and there is no reason to believe that the hair will be DHT resistant. So without DHT blockers, and repeat treatments (no idea if this will be doable), this can’t be a cure.

    In order to have a cure, you would need to repopulate the bald areas with hair that is DHT resistant, with a type of cloning approach like the japanese are trying to do. Otherwise, it’s just another treatment in our arsenal.

    • McJ

      Correct me if I wrong and assuming all were to go well, wouldn’t the hair last at least 2- 6 years or something like that – however long a cycle takes. And doesn’t the level of DHT in men decline as they get older?

      I’d take that if that were the case. I think most folks would. But too much is unknowable at the present time without further info. Given the way Olle was talking, I think substantial means a full head of hair. Otherwise, why bother. I get the impression these guys are in this to change the game. At the very least, to get there before someone else does.

      But you’re right, I need to see a picture before I totally lose my sh#t and jump up and down.

  • vin diesel

    OK enough sciency talk, when can I have my hair back?

    • Pedrada

      BUT…If you get your hair back you won´t be vin diesel anymore

  • Toni24

    Man can you believe if they ever came out with a solution to reverse balding. I can honestly say every investor would be a billionaire within the first year. I hope they figure something out I’d be the first one in line. I hope to god they come out with a cure

  • McJ

    Bit of non news but Puretech have revamped their website once again (still no redesign of the Follicabio page though) and it shows where all their various pipeline products are at;


    It would appear, according to the chart, that they are half way there. We know they’ve admitted to phase IIa. It will be interesting (and good hopefully) if the FDA process can be expedited as the Xconomy article indicates.

    Has anyone read or had access to this;


    Any new info in it?

    • Vikki

      I’m hoping the fact that they misspelled ‘Fluoro Pharma’ as ‘Flouro Pharma’ doesn’t mean they have poor attention to detail.

      Unless I’m wrong, and actually they’re trying to treat various disorders with flour.

      • McJ

        Ha! Good spot. Yeah, that doesn’t look so good. With the website rejig, they appear to overlooked that. We should let them know about that and maybe in exchange, they can give us some hard facts about Follica and when it might hit the market…..

        Not! (that’s a bit 90s but what the hey)

  • Froggy

    Aderans completed ALL their current phase 2 clinical trials!!!!!!!!!!
    So including the last one which seemed to be an extension of an old phase 2 clinical trial.

    We will probably have some news.

    • Herzog

      That’s cool. Where did you hear this?

    • herzog

      I just looked into this. It appears all their clinical trials for phase two have come to a halt as of the 7/9/13. No results are yet reported, but it’s odd that all 11 of their trials would stop at exactly the same time. Phase II trials prove that the therapy works. It sounds to me like nothing worked so they pulled the plug.

      I mostly think this because at exactly the same time they began liquidating all their equipment in their main office in Atlanta.

      This looks really, really bad to me for Aderans.


      • Froggy

        My joy was very short
        Indeed there are RUMORS (at this time) that Aderans stopped financing the lab. But according to those same rumors the crew is still working on Ji-gami and is searching for some new investors.

        There are many reasons for this:
        – maybe because the results are not so good,

        – maybe because Aderans have financial problems and cannot afford a lab anymore even if the results are good.
        – maybe because follica’s solution (or other) is better and will be very soon on the market (according to this article they will test a well knowned drug (so quick FDA approval) with a special devise of their own to disrupt the skin (probably no FDA needed).

        But if there is something to be affraid of is that if the rumors are true we lost one of the biggest competitors and the others might feel more comfortable on the release date.

        Let’s hope follica is working and we be soon on the market.

  • Froggy

    By the way, 2 important questions:

    Follica will test a well knowned drug with a special device to disrupt the skin.
    – So FDA approval will be fastest that’s sure but how many phase?
    – Also very important concerning the speed: will Follica be able to protect their discovery? Will they trick to protect the discovery by introducing new components? (Then they will need to run all FDA procedure).

    • curious

      Hey Guys, It seems that this conversation keeps happening over and over. Follica may have the cure or not (photos or it didn’t happen seems to be the philosophy around here). As far as the timeline goes, as I see it, it doesn’t really matter until there is a break through. We have seen a number of companies now go through phase 2 we perceived timelines that really didn’t matter because their invention/ solution did not work. What this means in regards to Follica is even if they have a product that has already been approved by the FDA, that means any safety trials would not need to be done (assuming that the medicine is applied in a similar way with a similar amount). Even then they would still need to prove that it works meaning the biggest parts of the trails would still need to be done. If it worked and worked well, let’s say after phase 2 trials, the FDA might allow them to fast track Phase 3 (again this is speculation and FDA might not care and make them do a full blown phase 3) allowing them to finish a bit sooner. Someone surely has said before that the FDA only bypasses trials for procedures/ medicine that could be life saving and only when there are no available treatments. I highly doubt that the FDA would consider balding in the same category as say cancer. The most important thing we can hope for are good results. Good results will give us the solution faster than a fast track through the FDA for a drug that does not work.

  • L

    Thought this was interesting. Tempered optimism, but it seems we get closer and closer everyday. Hope it’s not too much longer.


    • McJ

      Yep. Getting closer. A full proper cure doesn’t seem like sci-fi anymore but I’m just hoping that we’ll see something in the nearer term (Fingers crossed for Follica) that at the very least can give cosmetically viable results that last a few years.

    • Aleluia

      I tought that the 3d impressed hair could be used direct into the head, but i think it´s wrong:

      “If commercialized, this technology could be used by pharmaceutical companies in the drug discovery stage to screen potential promoters or inhibitors of hair formation. Consumer care companies would also be interested in this technology platform as it would allow them to screen the effectiveness of active ingredients in personal care products for hair growth.”

  • herzog

    Ken Washenik just disclosed that Aderans has stopped funding the their J-Gami research at ARI. He’s going to try to find private funding on his own, but the fact is that ARI is dead.

    In better news, Replicel just got 4 million dollars in funding from Shiseido cosmetics for exclusive distribution rights of their hair regeneration formula. Pretty awesome.


  • McJ

    Next bit of Follica info could come from here;

    A new era: The melding of drugs, devices and information’

    Daphne Zohar will be speaking at Biopharm 2013;


    Drugs and devices would certainly be up the Follica alley. Also Puretech Ventures is now PuretechHealth.

  • tk

    Where did you find that info about ARI? I can’t find any of this on the web.

  • Froggy

    So the rumors that I mentionned earlier are true!

    According to this video Dr Washenik said that his technology is working and that he is searching for some new investors.

    IF TRUE Dr Washenik will have to bring some SOLID EVIDENCE (specially after losing Aderans) otherwise he will not find new investors.

    So we will be fixed very soon. But this sound very very bad.

  • McJ

    Does anyone have any knowledge about patent applications and typically how long it takes from filing the patent application to actually studying it and/or doing clinical trials?

    It’s just, as was pointed out on the last thread and possibly also this thread, that the application for the patent regarding FGF9 was filed in 2009;


    disappointed, are you still out there? Any thoughts or insight on this?

    • Vikki

      I was listed as a co-inventor in a patent in 2006, and it took until 2008 until it was actually ratified. However, the work had already been done by the time the application was filed.

      • McJ

        That’s interesting… it’s certainly worth keeping in mind.

  • tk

    ARI’s results were probably a bit better than Intercytex or Replicel’s. Unger, Bazan, and even Gho went through the same thing.

    Simply injecting cells in the scalp won’t grow hair consistently, at least not with the current state of technology. Growing hairs in vitro (like the Tsuji lab), or in vivo (like Gho and maybe Nigham are doing) is the best bet for the next decade.

    Follica is just a wildcard. It’s just completely different from other procedures as it highjacks the body’s own regenerative abilities. My hunch is that it will work somewhat, but won’t turn slick bald into Zac Effron anytime soon, if ever.

    • curious

      When you say ARI’s results are “a bit better” it is a negative connotation.
      I still don’t know what people are complaining about with ARI’s results. I don’t have time to go back to the data and pull numbers out but from what I understand, at the very least, is that they are receiving results that are either equal to or better than those received with finasteride… and that is with a single injection! What is there to complain about? People want a treatment with no sides… yet we aren’t happy because we aren’t growing a full head of hair over night yet.
      I’d bet that if ARI was to release their product as it is, there would be a large number of people to use the treatment which would be very profitable… not to mention that multiple treatments would probably yield better results and in turn mean more money for ARI. Leaving me to believe WTF are they thinking by stopping the studies?

  • McJ

    Biopharm in Boston next month is something to keep an eye on;

    The Melding of Drugs, Devices and Information.

    Not hugely likely that anything might come up but possibly worth keeping a close eye on due to the whole drugs and devices part.

    • mmmmb

      I agree

  • Aleluia
  • McJ

    Follica appear to have filed a new patent a few days ago;



    This one appears to be called ‘combination therapy’. Another big name in the science field appears to be on the last couple of patents too – Seth Lederman.

    Can’t pretend for a second that I can understand any of what that patent says. But it’s a newbie at least.

    • Aleluia

      At least they are working!
      thanks for sharing

    • Boston

      It’s a shame, but this isn’t new. From my understanding patents are granted regionally. Your links are for the one for the US, here is the link to the earliest version of this patent: http://patentscope.wipo.int/search/en/WO2011123218 which is from 2011

      • McJ

        Ah I see. Wonder why there was such a gap in time between the filing of the patents. Are the US patents normally filed after euro/asian ones?

  • McJ
    • McJ

      I reckon the best things to take from this are that the science is strong, as we’ve known since this Xconomy article was published, and that Follica are going about this in exactly the right way. Properly testing it to make sure it’s safe and perhaps equally importantly, efficient.

      Given that the patent was filed in 2010 for Fgf9, I wonder have they progressed more that they are letting on with their clinical trials with Fgf9?

      Either way, let’s hope the translation of Fgf9 on human skin yields the results both men and women across the globe want – getting their hair back!

      As mentioned in the article, a long way to go (hopefully not too long!) yet but things are looking brighter for a solution to this. Keep at it science guys and gals!

    • curious

      This seems like a fluff piece meant to pat the backs of those who made a discovery that hasn’t been proven yet. What I can take away from this is that their initial news release about the product and how they were going to streamline the process was wildly exaggerated (surely by reporters, bloggers, commenters as well as the company it self). They should have been more careful in creating such hype around the “discovery” and not left anyone thinking that they had already tested this clinically. They still have a long road ahead of them and any progress they are making needs to be backed up by photos/ evidence. As I said before, the countdown does not start until we actually have a real discovery. When we start seeing pictures of people growing their hair back in a substantial way, then we can say “okay, how long until they get through the trials and that will be our timeline.” If they produce nothing yet again the timeline is meaningless. I 100% agree with you McJ let’s hope that the translation works well on human skin! Thanks for posting.

  • McJ

    This is the kind of hyperbole that doesn’t help;


    This almost gives the impression it could be available in no time at all.

    I think, after the initial discovery in 2007 and the now infamous NBC piece in 2008 – Follica weren’t quick enough to shut down the comments (albeit from a ‘tv’ doc) that this could be available in ‘a few years, maybe sooner’.

    That last press release, if you hadn’t already noticed, didn’t pick up a lot of media coverage – in fact i think it was really only picked up mainstream media wise by the WSJ. I think that was deliberate.

    It’ll be interesting to see now after this huffpo piece if other outlets pick up on it now – several months after initially being announced – and the steady stream of ‘cure on the way’ crap that we’re all sick of seeing.

    Bernat Olle acknowledges in this Xconomy article that they need to be careful about how they handle Follica news so if there’s big reaction on the way, we could well see them putting out those flames a lot quicker than they have down in the past.

    Personally my biggest hope is that they’re much further ahead than what they are letting on – that Fgf9 patent is from 2010 if I’m not mistaken and Vikki in the comments below made a very interesting comment regarding patents. It may be relevant to Follica or it may be a totally different scenario.



  • McJ

    This has been mentioned before but a week from tuesday sees a topic at Biopharm 2013 that in all likelihood won’t throw up any new info but is possibly worth keeping an eye on just in case – A New Era: The melding of Drugs Devices and Information.

    We know with a certain degree of certainty that a large part of Follica’s tech revolves around a device to remove a layer of skin on the scalp plus the addition of something topical. This topic would seem to be up Follica’s alley but perhaps even more so because Puretach and Follica’s Daphne Zohar is chairing the discussion.

    Again not terribly likely to throw out anything new or even anything related to Follica but you never know,

  • curious

    McJ I like your enthusiasm but I do have to say that until further news comes out regarding this procedure you are really grasping at straws. I don’t want to be a downer but we have to look at things realistically. I really don’t think Follica has anything here (yet) and keeping the buzz going is keeping a false sense of hope. I don’t want to say we shouldn’t have hope but I do think that reposting articles and digging deep/ reaching far to have something make sense isn’t practical in this circumstance. I agree that Follica has to be careful with that they say but I really think they are doing just the opposite. If I were to tell you that I had the best surprise that is going to change your life but I’m unwilling to tell you what it is, I’m sure you would get skeptical within the first few minutes and thus followed by boredom. Follica, along with other companies, have done this way more than once and for some reason we don’t learn as a collective. When I initially found out about all of these treatments, about 4 years ago, I got extremely excited and had told myself that 2015 was the year or close to the year that these things were going to happen. Call me a cynic but I now want to see proof and data, not some silly article written by the huffington post that states that all they really have done is create a “platform” for this technology to be tested. I’m not sure what that even means. I know you have the best of intentions but we have to walk this path carefully. We have made so much progress here but we need to stay vigilant ourself and to be honest. We need that so we can do some self reflection instead of obsessing. I truly hope for the best. When the cure comes it will be shouted across the world, not vaguely stated with no facts to back it up. I still say, picture or it didn’t happen. Cheers!

    • McJ

      Fair enough. Wouldn’t say I’m trying to keep it alive for the sake of it though. There appeared like there might be a genuine swell in news reports again after that unhelpful and misleading Huffpo click bait article.

      So far that hasn’t happened, which maybe might be a good thing, but I reckon that if it had, Follica might be prompted into making a statement that corrects certain misleading articles, like the Huffpo one for example. Maybe even giving us some solid facts.

      I’m a pictures or it didn’t happen guy too but at this stage, I’m not going to call Follica on their credibility. If they say they’ve created new hairs in humans for the first time, I believe them. They’ve got too many people with big reputations to either lie or in turn release a treatment that is only as effective as what we currently have.

      All that being said, it won’t come tomorrow and obesessing certainly won’t help and I agree wholeheartedly on that front.

      PS If I’m not wrong though, you said the exact same thing to me on the last thread about stuff I was posting and then Follica kinda laid out some big news. 2013 probably won’t see any further action on the Follica front but you can’t ever be too sure ;)

  • Aleluia

    Sometimes I feel a little bit sad sometimes for waiting for years about follica. But i really believe that they are doing real progress and what they´re showing now to us is past to them. Maybe in 2 years they´ll have a final product.

  • john terry

    Histogen’s Composition for Hair Growth Receives US Patent…

    Something to Cherish?


  • tk

    @john terry
    Histogen? Their stuff isn’t working so well. Better off putting all your life savings in Replicel stock.

    The biggets issue with Follica is weither or not it can be used on areas that still have hair. Are they sanding the skin deep enough to kill existing follicles? If not, then it opens the door to compounding treatments.

    It’s crazy how lives can be affected by hair loss. If your life was not affected, then you probably weren’t very outgoing or socially talented to start with. It’s destroyed my life so far, to be honest.