Hair-Raising Follica Study Could Point to Baldness Therapy

6/3/13Follow @benthefidler

[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.

Ben Fidler is Xconomy's Deputy Biotechnology Editor. You can e-mail him at Follow @benthefidler

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  • pedro

    When William Ju entered this company, it was all excitement and optimism.

    Now a new CEO assumes without a word from them. Why did Ju leave the team? Why this company is so damned secretive? There are thousands of guys considering doing a hair transplant, which is expensive and ridiculous in terms of results, and they can’t even give an idea, say wait a little, we’re close to deliver something good for you, we can’t tell you how close but we’re close!! I don’t know how they could tell us, but there should be a way. Say at least in which phase they are. That would help. Why can’t we know nothing, absolutely nothing??????

    • johndeere

      Can a drug applied to scalp bring back all of one’s hair that was lost? I think so. Latisse/bimatoprost did that to the eyelashes which is a kind of hair isn’t it? So another kind of prostaglandin, PGD2 probably, or another (try them all!!) should do the same with hair of the scalp and bring weak, dormant (there’s no dead ones, it has been proved by Cotsarelis himself) follicles back to life again!! Isn’t there a fucking sign screaming in front of these guys pointing this way??? Is it that hard to find a bald guy and rub PGD2 on his head and see what happens???

  • Boston

    Relatively easy read.

    “Current work is now focused on demonstrating that in human follicles, already identified GPR44 inhibitors also can reverse the hair growth inhibition by PGD2″

    • McJ

      Yep, interesting. I just hope he gets the funding he needs to find that needle. Always wondered why Follica didn’t snap up Garza too as he seems just as influential as Cots. But hey, maybe Follica don’t need him! Keep those fingers and toes crossed!

    • julian

      If it could be tested rapidly it would be great but we know these things take a lot of time so although we may be lucky enough to have a cure already, we shall wait years. Sorry, but I’m getting less and less excited with these things. The good news is always for the future. It’s always a step further.

  • nick

    looks like follica is dead, come back in tens years

    • julian

      I give up. So they need 2 million dollars to get a better treatment than minoxidil or propecia and that seems like a hurdle? 20 million to get a full head of hair and that seems like impossible?? bullshit, they have nothing. What is 20 million dollar investment to get a CURE for this shit?? BIG BULLSHIT!!! I just regret having hoped this mother… had something better than this to say, after so much time.

  • McJ

    I think this qualifies as Follica news. I got tipped off to a hairloss website just now – perhaps what Nick is alluding to quite gloomily below. You can see it here on this link;

    Basically this guy called Desmond was crowdfunded to fly out to S.Korea to get the skinny on the latest Hair loss developments at the World Hair Congress. Now, you can read for yourself but the gist is that Follica may be some way off giving you a ‘cure’. Something in the region of 10 years but that something could be released, if they had the funding, in a much smaller time frame that would be better than Minox or Propecia but not a full head of hair type ‘cure’. That would take about 20 million and 10 more years apparently.

    Soo, there ya go. The full post is worth reading. Not all doom and gloom. There may be some real hope for the future. It is of course possible that Cots is just saying this to throw people off the scent but I doubt it. At leasr if you’re a teen concerned about losing your locks or something, you don’t have that long to wait!

    • fuckedup

      let’s wait and hope the asthma trials with prostaglandins produces some hair as sides.. woww.. and this guy is the world greatest authority on the field.. we’re pretty fucked my friends…

  • McJ

    ‘disappointed’, if you have any thoughts on this, it would be great to hear it.

    I think if there was something better than minox or propecia on the market, it would be huge. Like, properly huge. Maybe not all doom and gloom here. Especially if Cots thinks that there is a potential cure still in Follica’s tech.

    • julian

      I’m not disappointed but I couldn’t be more disappointed. I think now we can forget about it finally. So they burned 20 million dollars and have something a little better than minoxidil, after all that hype!! great job!!!!

      • McJ

        Put it this way, isn’t it odd that after so much silence on the subject, we suddenly get quite a bit of info from the horse’s mouth? That’s one way of looking at it, maybe this is some type of subterfuge but I personally don’t believe that. All the same, we still don’t have much of an idea of what Follica can do – though they claim to be able to create new follicles in humans, which is very significant.

        I think Follica got people’s hopes up way too much back in 2008 so I can understand a potential backlash coming after this recent news but having something approaching a cure in 10 years or so is nothing to sniff at. Better than nothing. It would be good if Xconomy covered this news in some way.

        • julian

          I think this talk was really odd. Cotsarelis wouldn’t say a thing like that that way. Say they’re out of money??? need 2 million dollars?? or 20 million??? looks awkward… or was he drunk when the guy talked to him??

          • McJ

            See, either it was a completely unguarded moment – which is possible – or it’s just to throw this guy of the scent. Very hard to know.

            I mean, the market currently for hairloss products is roughly in excess of 10 billion. Products that are frankly crap. If you had a procedure that was even slightly better than minox or propecia, why wouldn’t you release it now and then release something better later. Use those funds to further fgf9. I don’t get it. Perhaps I’m missing something. The current market, which apparently only accounts for 10% of it is billions and yet…no product.

            I dunno. It’s not like puretech have difficulty finding money;


      • McJ

        I’d love ‘disappointed’ to throw in his two cents. Part me thinks the numbers don’t add up. If you have something better than what is currently on the market – which rakes in upwards of 10 Billion a year for not very good treatments – then why not release it and use those funds to pump money into fgf9 trials if that’s what will create a more fully realized, bald to full head of hair treatment.

        The more I think about, the more it doesn’t make sense to me. I’d love to hear a more enlightened opinion but years of being water tight with info and now all it took was a guy going to a conference and informally interviewing Cots and the floodgates open so to speak. Very strange to me

        • julian

          That is strange, you’re right. It doesn’t make sense really, I agree.

  • Lurker

    Been a while, I really think Cots is telling the truth. I think he’s been trying in his own way to put out a cure and he realizes that they are close to getting somewhere, but that means very little. It’s probably frustrating. I think he also realizes he’s not good at two things. First, research dealing with the FDA is tough. The FDA slows down everything. He can’t effectively do research in a timely manner. Hence, why he brought up Rogaine and Rogaine foam and how long even that transition took. Second, he’s not good at raising money. Follica has raised money, but not enough to get them through the hurdles involved. Trials cost money, research costs money… lengthy research is extremely expensive. If he’s saying we could get you “something”, but it will be about on par or just a bit better than what already exists, it’s a tough sell to obtain cash.

    At the end of the day Cots is a researcher. He is paid to do research. I think he’s actually frustrated that what he’s shown can’t be put out soon. Frustrated that the trials he’s conducted could give us a new product very soon, but won’t due to the hurdles we already spoke of. He knows, of course, he could keep moving but is probably tired of the entire process and in order for him to continue, he knows he needs money. This isn’t a gimic. It’s probably legit. In my opinion, we’ll see them trying to obtain more soon.

    I understand his point of view completely. I don’t think he would have said anything at all if what he was saying wasn’t true. I don’t think we should expect to see even this propecia/rogaine style product any time soon.

    • McJ

      Yeah I’m inclined to agree with most of that. Still, it’s odd that after all these years, it took one person with a vested interest in hairloss to meet him and he’s spilled more in about 15 minutes than Follica have over 7 or 8 years.

      Bit of a bummer overall I guess.

      • Lurker

        Agreed. But, we all know how hyped this thing was from the get-go. Follica et al probably told him to stay quiet in the beginning. Years later, I assume he’s kinda frustrated, even with Follica. They were supposed to be his vehicle to get this stuff out and in all honesty, they clearly suck at doing that if they don’t have the money they need. He’s got something, but can’t get it to the masses because of the legal bureaucracy and monetary thresholds that stand in his way. He wants us to know that. So, that’s my guess on why he’s speaking out now. But, I should say, are we so sure he wouldn’t have spoken out in the past? Did anyone actually go to him in person and ask him questions? Probably not. It’s funny because I live near him… I actually thought about it early on. I probably should’ve followed through.

        • McJ

          Yeah, again, that’s probably not unreasonable to think that. Follica did come out with all guns blazing media wise and Cots himself said in that NBC piece, ‘yeah, if all goes well, we might have something in a few years’. I guess he looks a bit silly saying that although there was an ‘if’ in his answer.

          But, who knows whats really going on. I am inclined to go with your theory though. Unless someone with a bit more insight has any thoughts. On the point of him being asked, I’m sure he’s been asked quite a bit over the past 5 or 6 years. However, if it’s someone with a vested interested in hairloss who’s traveled all the way out to S.Korea, maybe he’s less inclined to BS them.

          I’m not naturally an optimist and I’d love to think that this is all some sort of misdirection but Follica were really the best shot in the short term. Unless Follica get another injection of funds or have some super surprise around the corner, I think it’s best to keep expectations at a low setting. Hopefully ‘disappointed’ can chime in. Love to hear his thoughts.

  • McJ

    Though maybe just to add, there have been times in the past when Follica were thought to be have been dead and buried and that hasn’t turned out to be the case. It doesn’t sound great this time around but only time will tell on this one. I wonder do Xconomy keep tabs on this forum (and Follica) as it would be great to hear some official word.

  • Froggy

    Maybe Replicel is close to finish phase 2 and thinking about starting phase 3 in a near future.
    “based on phase 2 results we would determine the best location for a phase 3 trial”
    “RepliCel’s licensing partner, Shiseido, opens cell processing center in Kobe today for hair loss trial”
    More details at:

    • Froggy

      Shiseido announces plans to open the
      Shiseido Cell-Processing and Expansion Center.
      The center, located in the in the Kobe Biomedical Innovation Cluster in
      Kobe, Japan, will centralize research and development on hair
      regenerative medicine with an AIM TOWARD COMMERCIALIZATION.

      Regenerative medicine in Japan is an emerging industry which the
      government aims to foster through NEW LEGISLATION and revisions to
      existing law as part of economic reform strategies, in order to advance
      in this field. Shiseido has a long history of conducting comprehensive
      research and WORKING TOWARDS COMMERCIALIZATION of the regenerative
      medicine for hair.

    • julian

      At least this company is very transparent about its progresses and development. Hope they get it. It will take some time but there’s promise to their tecnology. And being backed by Shiseido is good reason for optimism. If Follica had something really good they’d would have already found a big partner and wouldn’t be begging for 2 million dollars? If Cotsarelis really told that there’s nothing more to say. They’ve failed miserably!!

  • allergansnext

    Let Follica and Cotsarelis go. Forget them. The thing with greatest potential, I think, is the PGD2. Other than this, The Replicel or the Germans idea of cloning follicles, which would solve the limitation and replace or enhance hair transplants. PGD2 or another prostaglandin, maybe even bimatoprost (waiting Allergan trials end maybe by the end of 2014 or beginning of 2015 we know), latanoprost or any prost.. these might be a good solution for mild cases, for thin hair. This dermabrasion Follica thing you can forget, it sucks.

    • McJ

      Seriously? Look, those are all good alternatives but Follica have been written off in the past and they’ve kept coming back. There are too many inconsistencies with that report from that guy on the hairloss forum. I’m sure he was actually there but there were too many contradictions with the report. It’s aint over till the fat lady sings and she very plainly hasn’t sung yet.

    • julian

      have an idea: it’s expensive though. But who knows? Bimatoprost and/or latanoprost injections like in mesotherapy rbut instead of using their bullshit cocktails of growth factors and minoxidil, use bimatoprost or latanoprost or both. Something like 1 or 2 mls a day. What’s needed is a intradermal injector, one of those guns where you put a syringe and needle and a lot of bimatoprost and latanoprost. The only problem is the cost of this experience. But I believe it should yield better results than minoxidil or finasteride alone.

      • McJ

        Plus why would Follica get a new CEO and make their ‘we can create new hair follicles’ announcement last year if they were a sinking ship? That interview that that Desmond guy got was utter nonsense. Has to be misdirection. I’ll say it again but time will tell with Follica.

  • Froggy

    The race is launched.
    Clinical trials might be very quick in Japan:

    In November 2013, as one of the new economic reform strategies, the
    Japanese government passed the Regenerative Medicine Law, which ensures
    safety of regenerative medicine, and approved revisions to its existing
    Pharmaceutical Affairs Law to:
    - IMPROVE THE TIMELINES for the development
    of regenerative medicine

    Maybe this is good:
    - Histogen (if they are still alive) is also conducting clinical trials in Asia. But is it in Japan?
    - But more important remember that Replicel is propably already at the end of phase 2.

    • curious

      There is no way that these guys are the end of phase two… the article below refers to presenting phase 1 data in February. Also the fact that this was only an oral study and it didn’t release the data on the website seems super suspicious.

      Also, referring back to your article… you can choose what you wish from this sentence “Shiseido’s state-of-the-art facility will focus on the continued research and development, and the commercialization of RepliCel’s RCH-01 hair regeneration technology.” I chose to read it as that they are focused on R&D (research and development) more than commercialization.

      Again here, pick what you would like “…the island has been developed as a focal point for research and development of highly advanced medical technologies with the goal of streamlining processes from research to clinical application and commercialization.”

      To me it seems like they are setting themselves up in a specific area where they are supported by R&D.

      And not to rag on you or anything, but seeing as we are internet junkies we should try to take the 5 minutes of research necessary before making bold statements of companies are finishing phase 2 trials when they have only just completed phase 1.

      And finally, to answer your question, Histogen (if I remember correctly) is in Malaysia but my memory could be bad and it could be the Philippines or Indonesia.

      • Froggy

        Excuse me!
        1) I’am not making bold statement. I just posted a little maybe with 3 links so you can read it and think what you want.
        2) Maybe is maybe. It is not a bold statement.
        3) If you want to do some research about other links you can but you missed somes.
        4) Speeking of bold statement what you are saying about phase 1 is also a bold statement.
        This is not because Replicel presented phase 1 results in february that phase 1 has just finished in february and that phase 2 has not begun several months ago.
        - Let me use your words “And not to rag on you or anything, but seeing as we are internet junkies
        we should try to take the 5 minutes of research necessary before making
        bold statements”:
        - There is a video of David Hall presenting interim data six month results from phase 1 from may 2012.
        The oral presentation of february is not suspicious because we had a slide of a presentation at the Waldorf Astoria from october 2012 (about phase 1) speaking of the upcoming phase 2 (at this time planned with 108 male patients) with a lot of data, pictures, facts about the process about phase 1 first results… And Replical already have a big partner.
        - Replicel is for sure in Canada (Vancouver), Germany (Berlin), Japan (Kobe). Are you absolutly sure that phase 1 has just finished in february and that they not already in phase 2 in one of those countries? Specially now that we know that Japan wants to improve timelines about this technology and we know that this technology needs only a few weeks from the injection to see the efficacity (phase 2 goal is dosage and of course efficacity).

        Based on that I am just saying that Replicel sayed:
        - Japanese government passed a law to improve timeline on regenerative medecine (including hair regeneration).
        - According to Replicel tweeter account “based on phase 2 results we would determine the best location for a phase 3 trial”. MAYBE this is a good sign to talk about an hypothetic phase 3 about a technology that show efficacity a few weeks after the first injections (except about cycling of course but this technology is tested in phase 1 from at least early 2012).
        - A research center opened in Japan with the aim of commercialization (so this is not a basic research in some unknown university without any preclinical trial or just on some mouse).

        You can’t tell that this is bad news!!! This is just news.

        I’am not saying they have a cure or they failed.
        I am just trying to bring some links with a possibility that this is good news because every one seems to be a little bit depressive after Aderans failed and those RUMORS about follica failling.

    • joseph

      The race? the race of snails!!!

  • McJ

    I guess there’s been a little bit of negativity after that guy on the hairloss forum ‘interviewed’ Cots but there were so many inconsistencies and a lot of stuff didn’t add up. Anyway, the guy who went out to S.Korea has been posting videos and I see this latest one has Cots go into detail about fgf9 and the Dkk1 thing that come out in January of this year.

    Bottom line is Follica is in the game until they say otherwise.Until there’s something in the clinic, I peronally won’t believe it but I think the positives outweigh the negatives at this point in time. The process, as detailed in the article above, works in humans and that’s huge in itself. How well it works is another question but perhaps fgf9 is a good indicator for further trials. Follica gets a name check towards the end of the presentation but the whole thing is worth watching.

    • disappointed

      Thanks for posting the video. This is much more substantial vs a casual interview/article. I don’t know of the interview you are referring to that is a downer, but keep in mind this is a Dr. C. presentation, not a Follica presentation. No mention of market, current methodologies, etc. etc. and of course no human trial data. The conclusion is that this is all well and good but Follica are the ones to answer whether these things translate to human. I know that in some cases Dr. C. and his lab looked at balding scalp and reverse engineered a mouse with e.g., a protein that’s lost in balding men. That’s a fine start but until the protein is blocked/amped up, depending on the pathway, in human subjects hard to draw conclusions. For example, Dkk1 is a “monkey wrench” in the system, but could be one of multiple factors involved.

      I just don’t know, hopefully they have some results investors in this climate would not just watch a ship sink slowly and lose boatloads of $$. 5-6 bad board meetings in a row and no results would kill a venture like Follica. It could be that they are simply accumulating data or if their investors are super merciful, allowing Follica to concentrate efforts on one of their other areas. the latterr would seem doubtful if their flagship tech is for hair regrowth.

      • McJ

        Hey disappointed, glad to see you chime in. The interview in question and the context surrounding it has a lot of holes to my mind. Basically a hair loss forum/forums funded a guy to go out to a hair congress meeting in S.Korea – the same guy who filmed the linked video – and got him to document the congress and conduct some interviews. One of those was with Cotsarelis.

        Now the Cots interview did not happen smoothly according to his account with Cots being slightly cagey about such a interview. In the end he got it and here’s the gist of it.

        Now the holes to my mind are, if you have a treatment that is better than minox or Fin, surely you would release it if all you needed was as little as 2 million? A drop in the ocean in VC terms, no? The other thing that niggles is that later on, this Desmond guy says words to the effect that other researchers are keeping stuff to themselves and not letting on how far ahead they are. Now, surely it’s conceivable that Cots, who was initially reluctant to give an interview, would just give this guy bogus info to get rid of him or fend him off?

        I dunno what to make of it to be honest. I guess I always thought that given the money already put into Follica and the news last year that (they claimed anyway) they had successfully grown new hair in humans for the first time that they were perhaps the ones to crack this thing. Be interested to hear what you make of all that anyway and the figures involved.

        • McJ

          Also just to add, in the link to that forum I provided, the guy said that Cots told him phase 2 was ‘completed recently with promising results’. According to clinical trials register, that trial finished in 2011 – which I wouldn’t regard as ‘recent’.

          • dissapointed

            Thanks, that is interesting…but also hard to interpret (unlike the Powerpoint presentation) since the “interviewer” isn’t a scientist and is jotting down some things and asking some questions, but without a trained background it’s tough to ask the right questions (or important follow up questions).

            Out of that list I’d say the discussion on #1 and #3 might be worth looking at more. The rest is garbage or conjecture not worth going at (Dr. C. famously put his foot in it with the Matt Lauer interview in 2008, right?).

            Again, the interviewer – this aint his thing, no matter how self-educated he is. I wouldn’t developed the details on #1 vs every getting to fgf9, etc. What did it cost Follica for Phase 2? It’s not uncommon for that cost to # in the 10′s of millions, so was it a real phase 2 and what was the max efficacy? It’s kind of odd to state “we are doing well but don’t have funds to continue.” So many eager scientists are getting rejected left and right because they haven’t made it to Phase 2. These guys are sitting there, and have Puretech on their side. So yes, you’re right it is a drop in the bucket. But then the statements make no sense because I think (let’s make it clear, this all my opinion), Dr. C. again, unfortunately, is blurring the lines between

            Part of the problem, and I don’t want to give the interviewer a hard time, is lack of staying on track with spontaneous follow up vs walking in with a set of prewritten questions. Questions like #1 were asked but not with immediate follow ups such as “results similar to propecia — in what time frame and lasting for years?”

            My response is getting long here. I stepped away and came back to this in case to think it over some more. Basically, we’ll probably have an answer in a year or two because Follica will have to fire most of its small group at a steady burn rate – 11million series A for six years? Of course everyone at the company will have a lower tier salary than someone on the first day at Merck, but 11 million plus a small Phase one+two trial… By this time next year they’ll have to have results of close shop. Very difficult to speculate without speaking to one of the scientists, are they going backwards and doing fundamental R&D to boost what they have in Phase two? You don’t carry out “on the job” R&D on patients in Phase three, that’s why some of the “answers” the guy in that link posted are a bit odd. Or possibly the company has tightened their belts and more in afundraising mode while a small bit of R&D takes place and Puretech drums up support for a phase 3 that is “as good as propecia.”

          • McJ

            Thanks, once again, for those insights. I know that this is all your own opinion but you’re one of the more straight forward/realistic contributors here plus you have experience in the field of biotech and generally know what you’re talking about.

            I’ve accrued a decent amount of knowledge in the past six years but it’s a drop in the ocean. I know virtually nothing and neither do most of these arm chair scientists. It’s good to actually hear some balanced opinions instead of wild conjecture or baseless accusations.

            It sounds cliched but you’ve hit the nail on the head (yet again!) – it’s a waiting game with Follica. Waiting to see if they’ve failed or (fingers crossed) succeeded. I had my doubts about the reliability of that quote unquote interview and they’ve only grown since I’ve read it. A couple of things stand out for me in the positive – the Fgf9 thing a little over a year ago today and the fact that they do have a new CEO in Neal Walker (though they’ve yet to announce that officially but he seems to have good pedigree in the field). Those things would at least indicate they have something left in the tank.

            Just one last thing, I think one of your points got cut off there;

            ‘Dr. C. again, unfortunately, is blurring the lines between’

            I think I can guess what you were going to say but would you mind finishing that thought? I’d assume it would be unproductive to give out such info to a random guy who cajoles you into an interview.

          • dissapointed

            Yes, sorry, I walked away when writing that post. Post was way longer than I intended but this area has seriously curious people like yourself and others who want to vote thumbs up or down like its a movie. It’s both science and business and not an easy area to get into.

            What I was suggesting is that Dr. C. often blurs what he thinks is possible vs the reality of the biotech world. Dr. C. is not a serial entrepreneur, and I don’t care how many advisory boards he sits on. The make a real product is a heck of a lot different than showing your best result, on your best day, in ~1-2 square centimeters on the back of another species such as mouse.

            Having said all that, Follica may be in trouble. Though companies with real VC backing generally don’t dry up the remaining 2-3 million (if they have that much in the bank or available from their VCs for a draw down). VCs aren’t a mom and pop store and need to cut the cord. The exception (sometimes) is when the entire infrastructure of the company is set up so that a few hundred thousand $ of more testing to see a “hit” is at a lower threshold now than shutting it all down and 6 months from now a scientist saying “wait, I know how we can test X.” So the sick feeling in my stomach is that the board, which has some genuine scientists in it, are going for the Hail Mary pass at a few more preclinical tests. After all, the pipeline – cells–>tissue–>mouse–>patient is set up.

            Follica aside, at the end of the day, I would focus on what people know are the proteins involved in hair loss and new technologies. Though nobody wants to hear that, I wouldn’t stress over this company. They are certainly an example of scientists and business people not knowing how to properly deal with the press (and subsequently potential patients).

          • McJ

            Haha, sorry – I may have upvoted you in the past but generally I tend to ignore those up/down things. Yeah, I appreciate it’s not an easy thing to explain to a lay person – though you do a good job – but I’m largely sanguine about the whole thing nowadays. I can’t do anything about it personally anyway but I’ll keep tabs on Follica and nothing more. I’ve been done for a while trying to find out whatever scabs of info I could find.

            Whenever I found out (got tipped of by a fellow curious person!) about the Cots ‘interview’, I was dubious and I still am frankly. Until they’re out of game officially, I won’t rule them out and I’ll say it again, I reckon you’re spot on about how in a year or two, we’ll find out what the score is. I think the Neal Walker hire is big positive;


            Anyway, as always, super informative. Thanks and as ever, I’ll check in periodically here and hopefully pick your brain again soon when Follica announce…something… I hope! Take it easy.

  • Bruck

    Hello all. I have followed Dr. Cotsarelis and his research, and have the utmost respect for him. I am in the medical profession, and actually understand much of his detailed lectures and writings. I find him to be very honest and intelligent and dedicated to finding a good treatment (topical medications) for hair loss. His work (and his collegues, including Dr. Luis Garza) are some of the best and most advanced I have read so far.
    And I am just as frustrated as most people that the progress has been slow, that many large drug companies are not yet interested in this huge potential blockbuster (25 million men, 20 million women potential patients by one study), and that the Phase 1, 2, and 3 studies are so expensive (2-3 million dollars each). I do believe that if anyone can get funding for hair research and potential drugs to market, it is Dr. Cotsarelis.
    From all us us, please hurry up…..!

  • Bruck

    Also, thank you Desmond for all your good work and dedication in bringing back a lot of good information for all of us.

  • McJ

    Not Follica related at all sadly but further contributions to understanding this problem;

    Mice yet again but ya gotta start somewhere. This would also appear to be a Chinese study.

    • dissapointed

      Thanks for posting. Actually, very interesting. This is basically akin to what Histogen has been claiming to do. The difference is that Histrogen would grow specific cells in conditions of low oxygen in order to induce a more foetal-like state to enrich for “factors” (some of which they clearly state, I believe).
      The difference here is that mesenchymal stem cells (MSCs) are in use. Nothing special with those cells (I’ve grown them a fair amount in the past). They grow for a limited lifespan, but in this case the MSCs are retrofitted with production of a specific Wnt. So the “Wnt-CM” the authors refer to essentially means growing the cells to a specific density in a plate and then not giving the cells fresh media but waiting a day or two for the cells to build up a ton of product in the media. The conditioned media (CM) can then be filtered to remove and dead cells, particulate matter, and used directly in patients.
      So bit of different style and specific Wnt than Histogen, but straightforward to scale up and ready for Phase I clinical trial as is.

      Personally, I think that until someone comes up with serious efforts in e.g., lower primate models, the current system will really be hit or miss. Propecia and minoxidal work in monkey models of “male pattern balding” but with mouse models straight to human it seems there can be quite a leap. The exception were the microarray results out of Dr. C’s lab but for whatever reason they are trying to troll big pharm to do the work vs just doing it themselves via collaboration with primate facilities or with better human skin culture models.

      Funny you mention its a Chinese study. Labs over there can produce crap but this study seems reasonable with no outlandish claims. Kind of surprised it got into Nature but the wow factor is that they are using conditioned media from MSCs – adult stem cells that are generally deemed safe – to produce a liquid product. Histogen does the same thing but with specific, rarer cell lines and more involved culture conditions, and with naturally produced proteins. On the other hand, the media collected from the MSCs could be modified to produce as many proteins as necessary, at different rations (e.g. Wnt1-highlevels, fgf9-low levels) and then injected into patients scalps.

      Definitely a pick-me-up for Independence Day. Have a good 4th.

      • McJ

        Wow, that is interesting, especially the potential for the MSCs to be modified to produce as many proteins as necessary. Yeah the Chinese part raised eyebrows for me as most studies in this area that I’ve seen tend to come from Europe or the US but if it made it into Nature, it must be someway credible.

        You mentioned the better human skin culture models, I remember seeing this earlier this year;

        Shouldn’t something like this eliminate animal testing altogether or is it a cost thing?

        • dissapointed

          Thanks and yes and no on the skin model. You have to keep in mind that whether its academic or a new company, those researchers are putting their best foot forward on a general platform for which a test drive by others has not taken place. The tech is so early that we don’t know if it will a good model. So it’d be like doing research, to do research. Any new tech will have risk so a more straightforward approach to getting a product must be done.

          You’re right, the Nature paper does give it more credibility and the STAP cell fiasco (really sad) reminds us that even top journals get duped now and then.

          The neat thing with the MSC study is that its believable, its within range/comprehension to most biologists. Though a hair loss vaccine would be great, its these simpler “why didn’t I think of that?!” studies that we tend to celebrate in translational science. Many in the lab (myself included) have generated transgenic MSCs, that’s no big deal. But utilizing modified cells as a neat “trick” to bypass special cell conditions and it makes a big impact. Especially when the Wnt protein had a substantial impact in mice (maybe not a homerun, at least a double or a triple). It says that physiological levels of protein for skin surface therapy can be obtained from cells in a dish. SOme questions are – which proteins, how much and how often?

          I do have a bias because I work in a different area, but an area that unfortunately involves a lot more technological effort for therapy. This approach would realistically be the first method offered up that is would allow for more competition because of lowered technical threshold and cost. Question is, who will get into the game? If I were at Follica, with a system in place, I’d bit the bullet and collaborate these guys ASAP to get in on the ground level of the IP. Might fail but if the Follica therapy is “as good as Propecia” and needs to do tests, this use of conditioned media is far more straightforward than laborious GMP preparation of a single protein.

          Or maybe Histogen could collaborate. Either way, I think its going to open the door for the smaller “home kitchen” companies to enter the race. I should stop there, post is gtting very long.

          • McJ

            No, not at all, it’s all fascinating stuff… the longer the better! No, the skin tech is interesting (and a bit frustrating) as, if I’m following you correctly, it’s so new that tests need to be done on it first to see how good it’ll will be as a means of testing. One for the future then.

            Really fascinating about how this recent discovery could open things up – maybe even in regard to Follica. This Neal Walker guy, given his background, may be useful in this regard.

            Even if Follica don’t move on this (or maybe they don’t even need to if they do have something up their sleeve) and, if like you say, it opened the door to smaller companies, that would be fantastic potentially.

      • McJ

        Hope you had a good 4th too btw!

  • McJ

    Erm, Follica have a new look website…is that news? I dunno.

    Very shiny looking. I like. Like a treatment more but hey, it looks good!

    • julian

      I think it is good news..

      • McA

        I’ve heard that before somewhere ;) Stay skeptical!

      • McJ

        Here’s the funny thing, they’ve updated their news section portion of the website and they’ve put in the Cots presentation video from that hair conference thing – ya know the one where the guy went to S.Korea funded by those forums and filmed it and got his ‘interview’ with Cots.

        So, they’ve obviously been paying attention (I still think that ‘interview’ was deliberate misinformation) but the curious thing is that they link the video that focuses on PGD2 rather than the one where he talks about FGF9 and actually name-checks Follica. So yeah, I don’t really know if you can read anything into that or not or the whole new web design thing. Worth keeping an eye on though.

        • julian

          They are really stressing the creation of new follicles rather than trying to regenerate the existing ones. It is a hint maybe that they have not give up the development of this treatment and still believe it can provide a solution. All is not dead, it seems.

    • Vikki

      Although I wouldn’t read *too* much into the new site, I think it’s good news.
      One quote from the new site : “Follica has an exclusive, worldwide license from the University of Pennsylvania to develop and commercialize a breakthrough technology ***that has been demonstrated to stimulate the genesis and development of new follicles in humans.***”
      (The asterisks are mine).
      Good news :)

      • McJ

        Mmm… we did know that before though to be fair with this Xconomy article. I think it’s a watch this space scenario – although it’s been that type of scenario for a while now – but certain things language wise may point to something positive.

        They do mention in their opening page about ‘Follica’s treatment’ which would indicate that they have something. Which I don’t think has been in doubt, it’s just how effective said treatment is.

        I’m definitely on the fence about it, I think it’s the best place to be. ‘disappointed’ may be able to chime in but I think the best we could maybe hope for now is an announcement about funding possibly, maybe an announcement about Neal Walker joining the company? Who knows but the new web design is much better than the last one.

        • disappointed

          Honestly would make very little of the website. I only would have thought something more of the update if there was the specific naming of a product. The company would not have to give away any trade secret, but naming a product and giving a time line on development. This makes me concerned on whether they are in the research phase, still, and not focusing on developing an actual product. The danger is setting the bar so high that no product moves forward and funding dries up (what funding do they have/are they getting?).

          • McJ

            Thanks for that, yeah, I’m unsure what to make of the timing. Why change it and why now? Technically there’s nothing new there language wise… it still mostly says the same stuff.

            It’s a slicker design no doubt but the only real thing of note is the inclusion of the S.Korean Hair Congress video featuring Cotsarelis. Not curiously the FGF9 video where he namechecks Follica but the one on PDG2.

            I almost thought of its inclusion as a tacit acknowledgement that Follica or the people at Follica have some degree of awareness of what goes on on the interwebs – certainly some of the talk about that Cots ‘interview’ that put Follica’s efforts in a more sobering light. I still think that interview was a misdirect of some sorts. It didn’t really add up for me.

            Perhaps I’m totally wrong in thinking that but I thought the inclusion of that video was interesting. Cotsarelis certainly features more prominently on the new website or his quote about hairloss certainly does.

            Yeah I’d worry about the high bar too but if they did have something that was only marginally better than what’s currently available, that would likely be huge financially. It’s still up in the air I guess. Maybe the new website is meant to attract new investors possibly?

          • julian

            I think the new website doesn’t say much but says something.. I would even risk to say that the image of the guy with open arms kind of thanking to the sky or Gods would be meaningful.. like he’s thanking for a miracle, the miracle that regaining hair would be in reality. Is it a hint that Follica has this miracle or is almost there or are optimistic that they may be close to or are just daydreaming about it like all of us? That answer only they know… and we can only wait and hope as always.

          • disappointed

            I think what I posted earlier was not written clearly enough. What I was getting at is that any biotech company with a real product in clinicals will often (not always, but often) have an indication for potential investors on drug timelines. In this case you could call it “wound induced hair regrowth” but there has to be a NAME of some type that Foll. Bio refers to in clinical trials. There is no such description with a progress bar. No offense to Foll. Bio but if they are going to meetings and not discussing the “progress bar”, it could very well mean they are focusing on research and not development. If the current results are 10% induction of hair growth and it would make most patients go from bald–>scraggly bald, doesn’t make sense to spend tens of millions to get to the end of Phase 2. But as I’ve posted at other times, the company has an assembly line in place, and even if the conveyer belt isn;t moving on now, it can be kicked on with a flip of a switch.

            The mouse to human translation of results is where a lot of biotechs die. Researchers get “some result” in mouse, and assume they will get the same result in human. And the further assumption is “with careful effort we’ll even get better.” When the results don’t pan out, what then – do you crush the lab or give them a few more shots? Another way to look at it is — do you stick to the cookie recipe that semi-sucks and try to build the next “Mrs. Fields cookies” on that and commit to 50,000 tons of ingredients? Or, do you try another recipe while you’re still at the mom and pop bakery level and have the ability to back off recipe #1 and try experimental recipe #2, #3, etc. while have all the equipment and no major commitment yet?

            I’ve seen this stuff in biotech all the time. Notice nobody here talks of the other applications of Follica Bio. Acne, etc. Likely because investors DO see the $ making potential if Follica wins out. There are so many things to considerso I better end it there. I don’t want to give false hope but my guess is that, for better or for worse, we will have to see drastic changes in biotech in the next 10-15 years.

          • McJ

            I see, ok… I like the mom and pop Bakery analogy…excellent! That should certainly clear up any confusion. I have to say in my head, ‘oh, new website, must mean something’ but yeah, not really the case.

            I do hope the likes of Langer and co point out, as you’ve mentioned before, the advantages of hanging in there. Certainly, financially, if they do indeed crack it, the rewards are huge. Billions huge. I posted some stuff up top – more recent findings and some from UPENN and Cots and co. Interesting reading with the Cots one as there are further findings on WNTs.

          • julian

            Timelines would be great but not naming a product doesn’t mean they don’t have it yet. The product may be called Follica too. I think it won’t be a product but a treatment so there is no need to name it, just the company. Follica is a good name already. A lot of people anticipate so why have another?

    • curious

      lol… their “new website” is a tumblr template… not sure if that is good news or bad news. Basically someone’s 14 year old nephew is now able to add information to the website, no coding necessary. Step back maybe?

  • Bruck

    What is frustrating is that the larger drug companies are not involved in the hair loss therapy research or clinical studies. With a potential market of 25 million customers (patients) just in the USA, and with Drs. Cotsarelis and Garza well along the research path, there should be medical trials further along. I know trials take money, but the potential benefits are huge. Any comments….?

    • McJ

      I think that’s a much larger question than a few lines could answer but from what I’ve picked up over the years is that it’s risk vs reward for a large drug company and the risk is too great. A lot of these things don’t get past phase II and the loss of money would be too great. Could be that Follica will eventually sell up to a larger drug company – who knows?

      Also I image the market for potential customers in the US is much larger than 25 million. I think the figures are something like only 10% of people with hair loss do something about it and that’s worth 5-10 billion or something… Imagine if there was something truly effective on offer and how that percentage would increase.

      Bottom line, there’s a huge financial reward for whoever comes up with a viable solution as the current treatments suck and suck badly. So where there is vast amounts money to be made, there’s always going to be someone there to cash in on it. I’m not one the naysayers who will say ‘not in my lifetime’ as we’re getting closer everyday but I think it’s still a ways off. I think Follica are worth keeping an eye on short term but it’s very up in the air with them at the minute. As ‘disappointed’ mentioned, they could be still be researching and with no new money coming in, that’s not good.

  • Bruck

    Could Ben Fidler (Xconomy)do a follow-up article on Follica and / or other firms (Histogen, Replicel) ,and how their progress is going?

    • McJ

      You could try twitter to ask Ben directly but Xconomy have featured histogen (wouldn’t be too confident with those folks tbh) only the once I think and I don’t think they’ve ever featured Replicel.

      Likely scenario is that Ben Fidler or anyone for that matter won’t have anything to update us with as Follica don’t say anything until they want to. No harm in asking but it’s likely to go nowhere.

  • McJ

    The Chinese are at it again;

    Although this is in collaboration with the University of Pittsburgh. This would appear to be another significant study to come from China since this most recent nature article;

    What do you think of the latest Exogenous connective tissue growth factor finding ‘disappointed’?

    • McJ

      Also this;

      Cots, Millar, Ito and Gay involved in this one. Wnt related.

      • disappointed

        I replied to this but the post was erased.

        I would make almost nothing of that paper. It is very basic research and low impact and potentially only slightly of interest to a particular niche field, within a niche field. Specifically, might slightly change how companies (if there are any) culture DP cells. The Holy Grail would be if they had something that caused DP cells to retain their basic differentiation potential even after months or years of culture (or e.g. 150 passages in culture, whichever came first). This type of thing peaked, and still continue to a lesser degree, with human embryonic stem cells.

        • McJ

          Thanks – the only bits of info I’ve picked up about the DP stuff and culturing them is that the biggest problem is retaining gene expression or something like that. I never was really able to get as excited about that method as I was say about Follica’s method as it always seemed quite a ways off. The nice thing about Follica’s method is the shorter time span for it to potentially reach the market. That and the somewhat simple elegance of it all. Well, maybe perhaps not so simple!

          • disappointed

            Too much speculation. Until data is shown I wouldn’t bet on anything. No idea what they are really up to. Or employee number. Or unspent capital. If it weren’t for my own work I’d like to get into this area.

          • McJ

            Well. that’s true but some of this has come from the company themselves about shorter time frames etc but yeah, it’s the old Hollywood saying, ‘nobody knows anything’. And despite the claim that they’ve created new hairs, they haven’t released any pics or data. I said it before but until the next press release, assuming there is one, it’s all up in the air I suppose.

            I see Puretech are hiring for some positions if that’s of any interest to you.

          • disappointed

            Ha, funny, I don’t think I’ve seen VC groups posting jobs for their start up. That’s a first (or at leastI’ve never seen that before). Interesting area that clearly has Langer’s stamp/influence all over it. But I actually have my own projects in a different area.
            I’d consult for free for Follica if it gave me access to their data ( I admit I’m curious) but otherwise have too much I want to get done in my own area.

          • McJ

            I’d second that motion! Hey Follica folks, we know you read this, let ‘disappointed’ do some consulting work! And pro bono no less!

            Yeah, I think – though I don’t know that much about VC and Biotech generally speaking – that Puretech have an interesting approach to various health problems. Obviously some of those problems are more serious than others but gathering the best people in their respective fields is ambitious and to be lauded.

            I don’t think they’ve had any ‘hits’ yet per say but they’ve certainly made positive noises about Gelesis and Follica. Most folks want to be skinner with more hair. They appear to know this.

          • McJ

            Just as a matter of interest, what are your thoughts on the replicel folks? I’ve never really given them the time of day but they appeared to have decent news earlier this year especially with changes to Japan’s stem cell laws;



    • julian

      thats for your grand grandchildren my friend… I wanna something much better much faster…

  • depressed

    growing hair should be as simple as getting rid of it by now. It amazes me how we’ve advanced so much in many fields but in medical science we are so slow.

  • Vikki

    Interesting stuff! Might have not so much impact for MPB sufferers, but very interesting nonetheless.

    • julian

      Scientists say as the mechanisms behind this condition are different, the therapy is less likely to prove effective for this more common problem…… well, less likely??? should be tested immediately for MPB, it’s obvious!! it may work as well, who knows?

    • McJ

      Yeah Cots spoke about it recently in the NYT;

      Anyone with regular mpb hairloss going near it would be crazy. The potential sides aren’t worth it. Cots does mention there might be something to a topical solution but that’s surely years off.

  • McJ

    So, this might prove interesting in the future.

    It may not seem like it but things are moving forward

    • julian

      yeahh, a slug is moving forward also.

      • McJ

        But a slug has noth…Oh, I see what you’re doing. Hey, look, it is what it is. Yesterday was the first time I’ve visited here in a while and nothing has really changed from a ‘will there be a new treatment soon perspective’ since last year really with the Follica fgf9 news. But there have been lots of little things in between that point to at least a brighter future for folks looking for more hair.

        Aint gonna happen overnight sadly.

        • julian

          its not overnight.. these guys have been talking about a cure since a lot of time. Follica in the beginning was all optimism and all they got after all this time concealing nobody knows what it is is a new website. REBOOTING YOUR SCALP… but this ING never turns into something real. There is a HUGE market if there was a breakthrough, something big, no doubt… if there was really something that could reboot our scalps, not just talk but an effective treatment, solution, whatever… these guys really don’t know what they’re missing. It’s just about 10 percent of sufferers doing something about it. 90 percent don’t consume anything and they’re right cause there’s not anything worthy to be consumed. If there was they’d do. Imagine the size of this market!!!

  • julian

    waiting for solution to this problem is like waiting for the Messiah to come back.

    • McJ

      Send a tweet to Ben if you want an update (you likely won’t get any reply other than to say ‘all quiet on the western front’ but maybe it’s worth a shot)

      Other than that, reread the article and take solace in the fact that they are probably at this point in time at that next step, trying 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.’

  • McJ

    Worth a look for those who are interested… Epigenetics, skin, hair and wound healing;

    There’s always another angle if something else fails although you can’t help but think there is something to all this wound-healing stuff… how long it takes, well, that’s another story….

    • McJ

      Just to add to that, wound healing and fgf9;

      Any thoughts on these ‘disappointed’? Seems to be a Korean/Chinese study.

      • julian

        Follicaaaaa… where are you?????

    • z79

      I would like to read this paper,
      Inducing hair follicle neogenesis by defined extracellular factors,

      Anyone have access to it?

      • McJ

        Goodness, haven’t seen the z79 name here in a long, long while. Long before I started commenting…. I don’t have access sadly but I read the abstract and this wounding thing does keep coming up. Certainly encouraging.

  • McJ

    Puretech just recently got a bunch of funding;

    Could be good news for Follica. We’ll see.