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 bfidler@xconomy.com Follow @benthefidler

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  • Very occasional lurker

    Cured yet? No? OK, see you again in another 5 years.

  • Keven

    I don’t think they’re even close. They used the media hype to secure money but nothing yet. I know research takes time but I don’t think those guys are legit. Five years from now they still will have nothing and brag about successful test, but will provide no evidence.

  • Boston
    • McJ

      Good find, this appears to be the PGD2 thing yes? I don’t think this one is Follica related even though UPenn is the applicant and wounding happens to be mentioned in one of their claims. Or do Follica ultimately own this stuff anyway?

      The fact that wounding is again mentioned is something that is surely a positive sign that this could really be a good way forward for treating hair loss. That and the claims Follica make in the above article of course.

      • Gab Broadhead

        It seem to be the PGD2 thing!!

        • McJ

          Follica weren’t actually on the FGf9 patent but it does appear, according to the marketwatch article, that in fact it is licensed by Follica so perhaps it’s safe to assume the above patent is licensed by Follica too. Olle does admit as well, in the above article, that they have been doing ‘a lot of work with topical formulations’.

          Would be great to know more but that’s not their way unfortunately.

          • Vikki

            Very interesting, and it’s also a worldwide patent. Seems to have been quite fast to be published. It was only filed in March this year, so it’s only a 6 month turnaround, which in my experience is quite fast.
            I need to read the details when I’m not so sleepy. It’s already quite late here in Denmarkzzzzzzzzzzzzzzzz

          • Colt

            Hi all- I’m wondering if anyone has thoughts on this latest patent. Seems like they are looking to both promote and inhibit hair growth, which is great for folks on either end of the spectrum!
            Does this latest one deal with wounding?

          • McJ

            Follica are apparently looking at both hair growth and hair inhibition (both huge markets so it makes sense) and yeah, the latest patent does once again mention wounding as a a pathway.

  • Gab Broadhead

    I hope they really make it happen! Thanks xconomy!

  • julian

    “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.”

    favorite part of the text, hope by substantial they mean A LOT OF these mtfkrs!!

    • tk

      @da6ef540c8428d4f23562c4116e0f206:disqus
      Thanks for pointing out that word. It is quite a change from the usual “significant new growth” that we are used to with Replicel, Histogen and all the others.

      The big question remains: can treatments be compounded? That would imply a quasi-cure.

      • julian

        I guess so!! I think that coupled with the awakening of existing miniaturized hair follicles would be amazing. I’m looking forward to this not being so forward.

    • CSJ Bofop

      That quote was already was already pointed out further down the page by Vikki…do try to keep up Julian :p

      In all seriousness, though, I agree with you, I think the choice of wording is quite significant in itself.

  • CSJ Bofop
  • Froggy

    Speeking of video we will have a video of Dr Gail Naughton’s presentation at the Stem cell meeting on the MESA.

    http://www.histogen.com/aboutus/news_events.htm#44

    Maybe we will have some details (new pictures etc…).

    Wait and see.

    • saveuslatisseplease

      Allergan will test their latisse version for hair throughout the next year, a new formula10 times stronger and if you want to root for something to come in the near term that is the one to hope for. If it works and is able to turn those little tiny hairs into thick, normal, big, healthy long hairs again then it will be amazing and it could be in the market real soon.

      • Froggy

        Thanks.
        Could you post on this forum as soon as you will have more news about latisse?

        • saveuslatisseplease

          I rather liked their decision. Others would have been too cautious and increased dosage just a little bit but they weren’t and elevated it 10 fold and let’s see what happens.. As I said, if it works and does just that, strengthen the hairs it will be cosmetically miraculous. let’s see.

  • Froggy

    I need to read it more carefully but it seems that according to this pdf there is nothing new (as usual).
    http://www.histogen.com/downloads/scmom-oct2013-final.pdf

  • Vikki

    Again, looks like this approach is miles from being ready for human treatment, but interesting research by some well-regarded scientists at Columbia and Durham:
    http://www.bbc.co.uk/news/health-24607696

    • McJ

      Nice find Vikki. It really is a matter of time – although in the case of this ever becoming a treatment, I’m guessing ten years or so. I’m sure there are more people and companies that we haven’t heard of that are looking into this.

      Interesting quote though at the end;

      ‘Our method, in contrast, has the potential to actually grow new follicles using a patient’s own cells.’

      All the more incentive for Follica who I’m sure are going as speedily as possible. There’s a goldmine here and whoever gets there first will reap the rewards.

      I still think this is a pertinent piece of info;

      http://blogs.wsj.com/venturecapital/2013/01/02/vc-in-2013-interwests-chris-ehrlich-on-why-life-sciences-is-a-great-place-to-invest/

      I’ve posted this before but the question about ‘biggest investment opportunity for venture capital in 2013′ and his answer could only point to Follica. I could be way off but the next piece of news we’re likely to get about Follica is new funding.

      • Vikki

        I hadn’t seen that one before. Seems almost like a throwaway line, doesn’t it?
        But I’d bet you’re correct. I wouldn’t be surprised if the next thing we hear from Follica is that they’ve scored a big old wad of funding. Which would be nice.

        • McJ

          It does seem pretty throwaway I must admit but it’s hard to overlook his past connection with the company. And also given that they advertised on the Wall Street Journal – it surely has to be a grab for more funding. Although they may not need a whole lot.

          Here’s an old interview that I think seems to be worth highlighting;

          http://www.fiercebiotech.com/special-reports/emerging-drug-developer-follica

          Perhaps what is most interesting is that they said that, with the last pieces of funding they got, they had enough to go from proof of concept towards an NDA. I guess, given the fact that they don’t have to go through as many hoops, that they don’t need as much money.

          Whatever piece of news we get next, I’d have to wager on it being funding. Hopefully though it’s the news we’ve all been waiting for (with some pictures of course) Are Follica going to be picked up or, as that interview suggests, will they expand the company to market the technology itself is an option.

          And just one more interesting link, this one from 2011;

          http://dermatologytimes.modernmedicine.com/dermatology-times/news/modernmedicine/modern-medicine-feature-articles/dermatologist-strives-stimula?id=&sk=&date=&%09%09%09&pageID=2

          This one from Vera Price in the last paragraph. To my mind, she can only have been talking about Follica here and Follica have of course (back in June) confirmed that they have grown new hair in humans. I’m not the most optimistic person but it’s hard to ignore these things. We’re not there yet but we’re not a million miles away either. I still think Follica is the best bet and I can safely say I’m eagerly awaiting the next piece of news. Just hope it’s not to far off!

          • julian

            “This field is wide open, and an investigator can make a major contribution, perhaps even earn a Nobel prize,” Vera Price

            It’s true, the scientist that solves this problem will earn a Nobel, and as I see it will be the most well deserved Nobel prize ever!!!!

            Hope it’s soon!! Cotsarelis, I’m rooting for you my friend!!! I want so much that you earn this nobel, dude!!!

          • julian

            well, Vera Price is a member and co-founder of Follica… Vera Price, M.D.Co-Founder & Member of the Scientific Advisory Board

            Dr. Vera Price is a Professor in the Department of Dermatology, University of California, San Francisco (UCSF) where she also directs the UCSF Hair Research Center and the Hair and Nail Clinic. Dr. Price is Founding Chairman of the National Alopecia Areata Foundation and the Cicatricial Alopecia Research Foundation, and an active participant in other leading alopecia societies. Her research on quantitatively measuring hair growth in patients treated with Propecia (finasteride) and Rogaine (minoxidil), the hormonal regulation of the hair follicle, and immunopathologic and genetic studies in alopecia areata have yielded numerous significant contributions to the field.

      • julian

        You may be right. They had 15,5 million dollars to spend but 5 years have passed since then. But they’ll have to show some advance in order to get more money, I suppose. With results they’ll have no problem to find investors, for sure. But with potentials I don’t know, I hope they’ve passed that phase and really have got something impressive by now. If they have it, money won’t be a problem.

        • julian

          correction: 16,5 million… one million more makes difference!! I hope they won’t even need more and are almost ready to announce the greatest cosmetical breakthrough of all time.. but I’m just dreaming now.

        • McJ

          Actually it’s 19 million. They must have gotten other funding. Presumably from Lighthouse Capital Partners. See the article on this page for confirmation of that number.

    • julian

      good news but seems it’s too far away… and I don’t know about you but I can’t stand hearing this word “potential” anymore. Please scientists stop saying this potential thing, it really sucks!!

  • Froggy

    Vikki thanks for this article.
    This article is about Prof Jahoda and Prof Angela Christiano.
    Do you remember Dr Colin Jahoda?

    In the 90′s (maybe the 80′s) he took hair cells from his scalp and transplanted them to the arm of his wife. Some hairs grew up. He made genetic test and discovered that the hairs were male hairs so his hairs. (The experience was published).
    After that we didn’t hear about him anymore.

    But some wanted to use Jahoda work by multiplying the cells before transplantation:
    - Intercytex directly based on this work in the UK => failed.
    - Dr Gho in netherlands => failed.
    - Aderans (who bought Intercytex) => failed.

    Let’s hope that follica (or some other) will be quicker than Jahoda. Or that this time he really have something.

  • Vikki

    Hey Froggy, yes I do remember Dr Jahoda, he’s done a lot of interesting work in the past.
    http://www.nytimes.com/2013/10/22/science/new-technique-holds-promise-for-hair-loss.html?src=twr&smid=tw-nytimes&_r=2&

    Bit of a more detailed article on the findings. Quite interesting that they were able to make hairs grow on a transplanted (cross your legs, guys) foreskin; an area that is typically completely hairless.
    Also, interesting to note that the lady in the photo at the top of the article, Dr Christiano, is herself a hairloss sufferer. Not that it’s apparent from the photo – wow, that is some head of hair. I’m jealous!

  • McJ

    Just an addition to the links Vikki posted but here are two smaller bits of info;

    http://www.abc.net.au/am/content/2013/s3873945.htm

    http://www.youtube.com/watch?v=0TBbu-e8HrA

    Now the first link doesn’t go the usual 5 years route but the quote from Jahoda does say people will ‘have to wait a bit longer’.

    The second link is from Fox but…the bit at the end is interesting. The bit about testing drugs on lab grown hair. Now this could be purely unfounded conjecture or it could be reasoned conjucture. I don’t know. The journalist in question seems to have a decent background. I seriously hope Follica are paying attention as this (hopefully) should open the floodgates for other competitors to enter the race.

    The Christiano/Jahoda claims of neogenesis are not dissimilar to that of Follica although Follica are taking a different approach entirely to neogenesis The main difference is that Christiano has published these claims. Follica are keeping the exact details under wraps, as is their right, but I wonder if they have something further to announce. Like I guessed before, it’s likely funding but possibly some further light may be shed on their findings.

  • McJ

    Here’s a date to look out for;

    http://www.dermsummit.com/program.php

    http://www.dermsummit.com/people.php

    There could be something to this one. Not only are Follica represented by 3 people here but it seems they’ve been hiring on the quiet. Dr Neal Walker is the new executive Chairman of Follica inc but he is also linked to another company;

    http://www.aclaristx.com/directors.html

    Guess what they specialize in?

    Novel topical dermatological therapies. Quite interesting.

    • Froggy

      Thanks Vikki and McJ for all those news.
      It’s very interesting.
      Follica seems to be more and more open.

    • julian

      Dr. William Ju is still the CEO? cause it says he has been… that means he isn’t anymore? and Dr Neal Walker is in his place? I didn’t get it right I suppose.

      • Vikki

        He’s Executive Chairman of Follica now, differs by company I guess but it’s usually a distinct and separate position to CEO.

    • Vikki

      Another great find, McJ.
      Very, very interesting. Just from a quick look, it seems like he’s got a fascinating background and seems to be kind of a big hitter.

      First off, his last position as CEO and co-founder was at Vicept, which was acquired by none other than Allergan!
      Other companies he’s either founded or led have also been acquired by major organisations like Accenture and Dr Reddy’s.

      I’m speculating pretty wildly again, but I wonder if he’s been brought on board; (a) because of the synergy between Follica and Aclaris (could they actually be developing a topical treatment together???) ;
      and (b) because he’s got a load of experience in selling start-ups to big pharma?

      Because both of those possibilities sound like very positive news to me, if I’m correct. (With the caveat that I could be way off.)
      On the other hand, he’s joined the company for a reason, you can be sure about that – which is also very positive news and means Follica are very, very much alive and kicking.

      • McJ

        Thanks Vikki. Yeah, I hope at least one of those is true! I was wondering about the relationship or potential relationship between Aclaris and Follica. We do know for sure that Follica did outsource some of their investigatory work and it’s a heck of a coincidence that Aclaris specialize is topical formulations for skin.
        I haven’t really been in doubt about Follica since the June announcement but what is interesting me a lot is their next move. Certainly Puretech have positioned themselves very firmly as a healthcare company so they could easily go it alone.

        It’s just waiting on that next bit of news! I hope it involves pictures! But yeah, it seems positive. Fingers crossed for the months ahead.

  • julian

    I’m about to getting me a really good good wig and glue it on my head with a glue spitted by a devil cause I can’t wait these motherfuckers anymore!!!
    pelasess!!!!!!!!!!!!!!!

    • juliano

      you don’t know how hair is important for some people.. you don’t know… sorry

  • hairyfuture

    who is the current CEO at Follica? Dr. Ju or Dr. Walker?

    • McJ

      No, I think it’s still Ju. As far as I’m aware, executive chairmain is different from CEO. Also, I think he’s executive chairman of the Board of Directors rather than of the company but I’m just guessing, I’ve no idea.

      • hairyfuture

        But there is said that Dr. Ju HAS BEEN CEO at Follica… has been is past, recent past or could be present as well, I have a little problem with present perfect. Help me please.

        • hairy..

          I mean, why didn’t they simply said he IS the CEO…??

          • McJ

            No clue. I wouldn’t read too much into the tense used. Follica still have him down as CEO on the website so he must still be CEO I guess.

  • Froggy

    Here you can see a video of Gail Naughton presenting Histogen at 2013 Stem cell meeting on the MESA:

    http://www.youtube.com/watch?v=_pUK7qRHfSU

  • curious

    So on some actual news you guys should check out the latest the Bald Truth Talk episode where they show a presentation of the new Pilofocus technology created by Dr. Wesley. That is a huge leap forward in terms of hair treatments even if it is still an HT.

  • waitingforamiracle

    … “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.

    If they delivered the news that really interests all of us they would see what is a HUGE response!!

  • fgf9

    It seems fgf9 is the reason why mice have showed success growing new hairs while humans don’t, they produce a lot of it, we don’t. Despite of that, maybe I got it wrong, it hasn’t been tested in humans so far and it is planned to START these trials in 2 years… 2 years??? just to start??? they can’t be serious. It’s ridiculous.

    • McJ

      Not sure where you got your info but there has been no timeline given for trials. And it’s no Follica’s M.O. to tell us anyway. But yeah, waiting sucks in general.

  • julian

    hey guys, take a look at this… http://www.baldtruthtalk.com/showthread.php?t=14773

    • julian

      they said Follica’s Ceo had stated they were close to a final product but didn’t show where this information is.. forget it..

  • McJ

    Probably unlikely we’ll get any further Follica news or updates in 2013 (or for a while after that for that matter) but Puretech Ventures have a presence at this;

    http://www.eventbrite.com/e/xconomy-xchange-healthcare-gets-personal-tickets-9277678787

    Not hugely likely anything comes of this and in fact, if we were to get any news, it could come from this in 2014;

    http://www.dermsummit.com/program.php

    Several members of Follica will be at this but again, history would tell us not much info comes from these things, at least not to the general public. Here’s to 2014 folks! (and hopefully some announcements that we can get properly excited about)

  • Aleluia

    2013 is almost over and we´re still bald my friends
    Hope 2014 something good happens

  • McJ

    Well, this is interesting. Not Follica related I don’t think but George Cotsarelis is back in the news again;

    http://www.eurekalert.org/pub_releases/2013-12/uops-apc120513.php

    UPenn are invovled and trainspotters will notice some Follica related people namely Mayumi Ito (he appears on several Follica patents) but I’m not sure if Follica will have any involvement with this one. Maybe they will, who knows. Watch this space.

    • Froggy

      If I am not wrong Histogen is already working on wnt proteins for several years now.

      But is it exactly the same thing?

      If so maybe Follica will work on fgf9 AND wnt proteins to find the best solution.

      • McJ

        Yeah, I think you’re right about Histogen but I’m not sure if it’s the same thing. I think Follica, at least according to the very early articles, were/are working on the wounding, wnt pathway and have been for a while.

        But yeah, another piece to the puzzle. It will be interesting to see if Follica happened to respond to this latest research – given the people in the press release that have affiliations with Follica.

      • julian

        yeah. Another piece to the puzzle.. I just hope it’s not one of those 1.000 pieces puzzle and it’s just 3 pieces found and a bunch of chimpanzees trying to put it together.. hope it isn’t like that!!!

    • Froggy

      By the way thanks for this article and this new piece to the puzzle.

  • McJ

    Could well see something from Follica regarding this – lots of mentions regarding WNT proteins and Sarah Millar is a scientific adviser/board member of Follica. Implications for hair growth, ceasing hair growth and potentially treating skin tumors.

    • McJ

      Here’s an article that lays it out in fairly plain english what this discovery means;

      http://life.nationalpost.com/2013/12/06/skin-molecules-that-cause-baldness-unwanted-hair-identified-as-u-s-researchers-discover-ways-to-disrupt-both-processes/

      How or even if this relates to Follica is debatable but it’s another vital piece of info no doubt.

      • julian

        This is consistent with what Cotsarelis had said before. But where all these things meet? I mean, there’s the fgf9, the prostaglandins, DHT, wnt, stem cells alive in bald spots… etc… and Follica’s work, which claims to being able to create new hair follicles. Now this research seems to be focused on reactivating the dormant ones and making them resume the production of normal big hairs. What to make of all these findings and is it possible that Follica is going to use them or they don’t need them if the can make good hair.. strange..

        • disappointed

          It all depends. And Cotsarelis does not = Follica. He is a founder, and has share in the company, but make no mistake about it, Follica is on its own. Conversely, if anyone at UPenn or elsewhere is going to continue to study skin and hair development (a big field) they are able to do so. Just because someone collaborates with George C. doesn’t mean the work is property of Follica.

          Probably safe to assume Follica is not going to throw their original wounding strategy in the trash if they claim to have had some success.

          • McJ

            Hello disappointed, you’ve been away a while. What did you make of the FGF9 announcement and the Xconomy article? I’d be interested to hear your thoughts.

            With regards to the latest bit of news, there are other Follica people besides Cots who are involved – namely Sarah Millar and Mayumi Ito. It seems like too much of a coincidence but then again, that’s a wild guess on my part.

          • disappointed

            hi,
            The fgf9 is interesting because it’s druggable. If all the tech Follica is using is based on would healing and addition of a purified protein they will have a lot less obstacles to face than a stem cell or cell secretion mixture like Histogen. My only question, which I’m sure is top priority, is how big the wounds are. WHY a HT surgeon hasn’t simply tried minor wound healing and addition of Wnt, etc. on their own simply amazes me, might lead to a go or no-go scenario in most people’s minds.

            On the paper — As technologies go, if the phenomenon observed in mice works in human, great. The danger is the lack of mechanism. For example, if the tech simply didn’t work in human then we’d be asking why and noting that wounding historically has shown results in mice and rabbits and so on. In this case, the Miller-Cots collaboration is useful in that they can take on what Follica probably doesn’t have the power to do – basic biology to determine mechanism. That gives Follica the power to say why something did or did not work. Prior to this work, they couldn’t look at human gdTcells or if Fgf9 was suddenly appearing at the wound site, but now they can look. Also, choosing Wnt as a protein additive may provide obstacles. However, there will be a lot less resistance to trials with Fgf9 if (big if) it’s known it is the agent naturally shed by gdT-cells at a wounding site in humans.

            In theory, should be simple enough for Follica to get a license to any Fgf9 patent (UPenn of course wants Follica to succeed, they’d own a %).

            Problem, as always, is that this seems to be mouse work. I don’t know why Follica hasn’t even published a short paper on results in human. Probably because they know its such a emotional powder keg. Let’s face it – guys are pioneers, protect their families, and start wars…. all because of one little molecule called testosterone (ironically the source of hair loss). They(follica) learned their lesson and clearly don’t want to tick off guys with MPB.

            Overall, more optimistic on this than before because hair growth and wound healing is seen across species but more importantly is that this is a platform.

          • McJ

            As ever, really great insights there. Thanks again. I guess we can safely summarize it as cautious optimism! More caution than optimism is still best but yeah, some interesting things to ponder there.

            I think you’ve nailed perfectly why Follica haven’t shown the results of those human trials – well, one, they are under no obligation to do so but it’s just such a hot button issue and after the initial 2008 discovery and news hype, I think they got a little burned and have learned to, as Olle says, ‘be careful about how we deliver the news because there’s all these huge responses’. Plus it was a very targeted release of news. Aside from Huffpost catching wind of it months later, it didn’t appear in any mainstream media – with the exception of the WSJ. That’s a point I’d like to get back to later.

            I do take them at their word when they say they’ve been able to do this in humans so that’s a huge plus in terms of how they hoped this would translate in humans. There are all sorts of other questions as to how good or how terminal the hair is but the fact that they’ve found that humans can do this is great.They have said that preclinical tests have been done with FgF9 but I thought that was an odd one because they’ve known about the FgF9 thing since at least 2009.

            http://www.google.com/patents/EP2361119A1?cl=en

            Is a lot of the work not done before a patent is filed?

            But back to the WSJ piece. It was basically a reprint of the marketwatch article. Why be so specific with targeting the WSJ? Surely to drum up some more cash, no? Because aside from Xconomy, no mainstream news source got wind of it. Apart from huffpo but even then, it didn’t go beyond huffpo. The last piece of news was from here;

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

          • disappointed

            Welcome, I don’t stress on this like I used to, but hope that the investors aren’t so nearsighted. That is one place a Robert Langer type helps, he’s gone down the long road of getting tissue engineering and stem cells into the clinic and its not like a drug or medical device where the payoff/indicators are more akin to what VCs like.

            No idea on why the article is in WSJ but if they (follica) are getting results and need cash, they have a team who will bring in money without a problem.

            On fgf9 and the patent, it may have been mentioned as a potential factor (e..g an obvious secreted protein to try, based on the literature, to someone trained in the art). And there must be precedent of fgf9 and wound healing on some level. What this Miller paper found was more specific on mechanism. Sometimes there are players present that we know of but it may be years until you find the source and mechanism (in this case gd T-cells recruited to a wound site)

          • McJ

            I see. The reason I brought up the patent and when it came out was because I thought (and perhaps was naively hoping) that maybe they were further ahead with the FgF9 experiments/trials than they were letting on. They did, after all, do clinical trials largely on the quiet.

            Interesting you bring up Langer. They don’t mention him as being connected to Follica on the follicabio website but they do mention him as being with Follica on the puretech website along with Entrega and Gelesis. I linked to an event on this page that is happening in the New Year where several Follica related people happen to be speaking. William Ju is one of them but it mentions his involvement with them in the past tense. I didn’t think much of it at the time but is it perhaps possible that someone like Langer could take over the CEO position at Follica if they were close to bringing something to market? He’d certainly be a big name to have at the front of any type of media event. He also has his foot in the hair care market if I’m not mistaken.

            I’m speculating so wildly here, it’s probably not fair to ask for your input on that. A solid fact I did find out though was that Follica did hire a new Executive Chairman last year. Dr Neal Walker. He has an interesting background to say the least.

          • disappointed

            No, Langer taking a role as a CEO is simply never going to happen. He’s a legend in biotech/drug delivery and probably has a net worth in the hundreds of millions (if not more half a billion $). The reason I mention him is he likely does sit in on at least the occasional board meeting, and his thoughts/advice would have major impact. No offense to Zohar but she’s very green, the newbie in the room and all money manager (even if these VCs talk science, they are full it, they just want to multiply money whether its tissue engineering or a porn website). So another way to say it is what Follica wants could take time, and VCs get impatient and, sometimes, cut the cord when the going gets tough and positive results are just over the hill. Langer would know this from both the scientist/inventor and investor side of things and hopefully give Follica the best shot they could hope for. Follica may still fail, but hopefully not for stupid VC decisions.

            Nothing against Ju, but he’s fairly meaningless unless he comes up with some great business model or helps leverage a buy up by e.g. Merck. Otherwise its the scientists and clinicians in a bubble, so let’s hope the have some hits. All the rest who sit on the board aren’t stupid, but they’re getting a condensed version of what is going on every 6-8 weeks and likely 2-3 ‘top guys’ in the room make the decision on whether they like what they see. It’s when there are 4-5 board meetings in a row spanning half a year of nothing but bad news where real wisdom from a langer type needs to be exercised (e.g. are these birthing pains of a new startup or has the tech, based on hard core science, really gone to sh*t).

            Keep in mind biology is not easy, we simply don’tknow all the principles involved in how a cell functions. That’s why we sent someone to the moon in the 60′s but have taken so long to make a dent in some diseases.

          • McJ

            Ok, cool, that’s certainly set a few things straight. Thanks for those insights. I think it’s a good thing to know to that, even if (big ‘if’ as you say) things go well, this could still be – what – a few years at the very least. I think Follica are still the best shot by a long way but reading your last post, it does certainly dispel the myth that Follica – if you believe certain huffpo articles – are somehow close to market.

            I was never that convinced that a product was that close, I hoped but was never especially sold on it. Since reading the most recent articles. If they’ve only done preclinical work with fgf9 and even if they don’t have to go through as many hoops, that’s still something in the region of 3 years I guess. All going well. Not to complain if that is the case, that would be great but those huffpo articles get people unfairly hyped up.

  • julian

    it will come!!! sooonnnn

  • McJ

    Another day, another day another… you know what’s coming;

    http://www.redorbit.com/news/health/1113033255/stem-cell-research-could-cure-for-baldness-122013/

    A lot of deja vu with this one… specifically the ‘might translate into novel therapeutics for various human diseases’ bit.

    Good luck to them anyway. Even if they sound exactly like Follica in certain areas.

    disappointed, I don’t know if you saw this link;

    http://www.dermsummit.com/speakers.php

    Any chance of Follica news do you think? Of course, if history has taught me anything, there’s not likely to be any Follica news here (or even for a long while) despite the presence of some key Follica folks.

    Anyway, happy holidays y’all. Here’s hoping to 2014 having some good news!

    • disappointed

      On the first link to those publications – I would not say that is in the same class as Follica. It may translate but Follica has a unique platform in that bioavailability,stem cell GMP practices, etc. are non-issues. For example, any company needing to grow and deliver stem cells of any type needs massive backing. Whereas Follica has a realistic approach of micro wounding+drug/growth factor addition, fast track compared to a standard drug.

      No idea on link #2 and Follica news. They know there are individuals aggressively seeking out info. Individuals who, quite frankly, are NOT beaten down from a tumor, chemo treatments, and struggling for quality time with their loved ones. Instead a lot of otherwise physically healthy individuals with nothing but time to vent and aggressively pursue! The well water has been tainted so I would not expect a peep from Follica unless there is a breakthrough or another round of investment leads to VCs who briefly justify their new investment with progress X and Y.

      • McJ

        Yeah, I’d meant more in the press release type sense in the similarities to Follica, not the tech. Follica, certainly, have designs outside of hairloss with regard to their tech. Those folks at USC were using similar language in that sense, talking about skin regeneration etc.

        The second point hits home something that’s been on my mind for a while now, certainly since that Fgf9 announcement. I’ve been guilty in the past of searching for any bit of Follica news I could find – hopefully (and I don’t think) not too aggressively. I squirm a little bit when I think about how once Daphne Zohar’s twitter account came to light, a bunch of guys (and they were almost certainly men) decide to bombard and insult her. Utterly pointless ramblings from solipsistic, self-entitled a-holes.

        Which brings me to now. The best bit of news in ages is the above Xconomy article. Any further info as you said is either an announcement of a breakthrough or further funding. There isn’t much else you can do except wait and as you very astutely point out, there are folks out there who are in much dire situations. A sense of perspective is often missing.

        I’ll check in periodically but for now, there’s no real rhyme or reason to be searching for grains of news or info. Follica are alive and well and they are the best shot in the near term for a viable hair loss solution. That’s reason enough to be thankful as that hasn’t been the case in the past. I hope you still continue to check in too, disappointed. As ever, thanks for your thoughts and your candor.

  • Javier

    The CEO (William Ju) is out according to his LinkedIn profile. Looks like the party is over.

    • herzog

      He left back in July of 2013, about a month after the Fgf9 discovery was announced. They could easily be changing management to better handle their new model. His being gone changes nothing.

      • Javier

        That long ago! Why do you think he is still on the website, if the company is still active?

        • Aleluia

          This kind of outdated information on follica´s website shows the uncompromising way of they´re working.

  • julian

    what came out of the Dermsummit conference, anyone knows? I suppose ZERO information from Follica, as usual.

    • pissedoff

      off course nothing… these conferences are bullshit, worthless, they’ll never give nothing new.

  • julian

    Replicel almost every day posts something regarding their progress.. it’s the exact opposit of Follica.

  • Aliyah@Hair Extensions

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    http://tapehairextensions.net.au/

  • McJ

    Just to add to the William Ju exit and it’s been posted elsewhere but Follica would appear to have a new CEO;

    http://businessprofiles.com/details/follica-incorporated/MA-203136861

    It would appear to be Neal Walker and he has a pretty impressive background as detailed in the comments here. I’d guess there might be something official when they’re ready to announce their next piece of news.

    • julian

      William Ju is cited as director now. So he is still in the company?

      • McJ

        Oh, I’ve no idea man. I mean, the link says he’s still a director there so I guess that’s the case. At the very least, I’d still expect him to be a board member. Just hoping that the new CEO takes Follica across the finish line.

        I imagine, again I’m guessing, something will be formally announced if and when Follica are ready to talk again.

        • julian

          it seems he isn’t a board member, at least he is not included in the team of Follica’s website.. http://www.follicabio.com/content/team-and-advisors/

          But Neal Walker is not mentioned as well… so…

          • McJ

            Oh, that’s interesting. He must have been scrubbed from that page relatively recently. The Follica website isn’t great for updates to be honest. You have better luck with the puretech health website;

            http://www.puretechhealth.com/

            I’m sure he’s still on the board like a lot of the other faces you no longer see;

            http://www.follicabio.com/content/board-of-directors/

            But I’d guess the Neal Walker announcement will happen when/if they have news. Wouldn’t be too shocked if we don’t see anything for a while though.

  • James
    • julian

      Good but another promise again… tired of that s***! We need something closer…

  • McJ

    Some further stem cell news today…

    http://www.newscientist.com/article/mg22129542.500-stem-cell-power-unleashed-after-30-minute-dip-in-acid.html#.Uuklefl_swE

    http://www.bbc.co.uk/news/health-25917270

    If you read the first link,it does mention injuries like a burn causing mature cells to revert back to stem cells. Something Follica and Cots have known for a while but this latest discovery goes way beyond hair loss. Exciting stuff.

  • puto

    quando esses filhos da puta vao lançar essa merda???

    • fuckem

      in 2050 maybe

    • Derrick

      Someday we´ll know…

      • puto

        how I wish this day was within this year!!

  • desperado

    wheeeennnnnnnn?????????????

    • disappointed

      why not do some research and inform the rest of us.

  • beatleswig

    Mister Cotsarelis please Mr. Cots look and seeIf there’s something in your lab for me
    I been waiting such a long time
    Since I heard you’d fill my receding line

    There must be some word today
    From Follica that’s always so far away
    Please mister Cots take a look and see
    If there’s a hairier, a hairier future for me
    I been standing here waiting mister Cots
    So patiently
    For just a word to just feel better
    Saying my hair’s returning home to me

  • McJ

    Well, it’s not news and it’s certainly not going to assuage the doubters but it’s a response at least. Puretech addressed some Follica queries on their twitter feed.

    https://twitter.com/PureTechH

    ‘Advancing’ is better than nothing and in the near term, Follica are the best bet.

    But it’s still a bet. Anything else is likely 10 years plus away. Keep your fingers crossed and with a bit of luck, there may be something. Hopefully the something we’ve been waiting for. Hollering at them and berating them achieves nothing. It’s can be cathartic to vent I guess but you have to be thankful there’s at least the possibility of something on the horizon.

    • julian

      Couldn’t be more vague… is advancing the development… will update when we have news… but thanks to that vagueness we are here. I just think they could be a little, just a little less vague. Wouldn’t do any harm.

      • McJ

        It might though, maybe that’s why they’re being so cautious. I don’t know.

        I rather this than a missing or postponing a certain date or timeline. I’d love more info too, I’d love some certainty. But we’re not gonna get it until they’re certain I suppose. I think my whole thing now is, I can’t do anything about so there’s no point in fretting over it. It sucks but as I said, there’s potentially something on the horizon. That’s something at least.

        • speakfollica

          … consistently create substantial amount of hair follicles.. they can do it, as they claimed. It was said also that these hair follicles function normally and produce normal hair.. Then, what is missing?? if they can produce significant amounts of normal new hair follicles the problem is solved isn’t it? put this goddamned product/device to work finally… there are billions of people in the world avidly waiting to use it, or this guys don’t know that?

          And there are those who think that a “cure” for baldness would never be available cause that wouldn’t be as profitable as the current treatments that have to be taken for life. Bullshit, don’t you realize that if there was a real good treatment that could make a real difference, many more people, if not everyone in the world would go after it and would be willing to pay much much more money for this solution. A large amount, maybe 90 percent of the hair loss sufferers don’t do nothing and don’t spend a dollar because they know the results are not worth it. A really nice solution to this mankind-old problem – THAT IS FAR FROM BEING ONLY COSMETICAL – IT AFFECTS HEALTH, IT AFFECTS THE LIFE of millions and millions of people (for the retards that still didn’t get it) – would certainly make a greatest fortune in the history of pharma.

          • hairlover

            you know what is cosmetical? cosmetical is when I decide if I color my hair or not, if I cut it short or use it longer, if I part it from the side or in the middle, if I use gel or prefer it dry, these are cosmetical issues!!!! if I can’t choose the way I have my hair, If I am forced to shave my head or look like Bozo isn’t a cosmetical matter!!! it is a tragedy!!! it will make on sadder, it will ruin ones self esteem for life, this isn’t cosmetical!! this is well being, heath, mental health, this can affect life in so many aspects. The ones that really suffer and miss their hair know what I’m talking about. There are people who really need their hair!!!

  • fuckedup

    advancing the development… ow my god, really?? thank you pure tech!!!

    • believer

      medicine is a shame!! finasteride was the last thing they discovered BY CHANCE and it was 20 years ago. Since then NOTHING!!! Minoxidil BY CHANCE 30 years ago!!! Latisse BY CHANCE too!!! So we are in the hands of luck, not of science.

      • fuckedup

        20-30 years without an innovation is a shame indeed. Doctors are second grade scientists.. I bet if physics had an interest in something like that they’d have found a cure years ago!!

  • keepthefaith

    hope Allergan makes it happen with their boosted new formula for bimatoprost whose trial is in progress. Hope they get it now and are able to provide a much better/stronger treatment than fin or minox.. If weak almost dead tiny follicles are turned into healthy again then it’ll be a big deal. If they can grow big again and resume production of thick, long, normal hair the cosmetical change would be noticeable and amazing. Guys with thinning hair would get them thicker and full again. Since it’s an already known drug I suppose it would be marketed pretty soon, all depending just if it’s effective. As for Follica, it’s like waiting for a miracle, like waiting a word of God..

    • fuckedup

      that’s what latisse did for the eyelashes, grew their follicles… it’s believed that despite eyelashes and hair follicles function differently, they have similarities as well, receptors are the same or something like that. So, it’s not impossible that bimatoprost can activate them again.

      • believer

        if it proves effective it will go to market right away, Allergan won’t miss their time and cash. This guys love and have loads of money!!

  • Hopeisall

    If anyone wants to do some digging.

    http://www.plainsite.org/flashlight/index.html?id=4188447

    Cosmetic use of organic resinates

  • anxious

    Follica Touts Cure For Baldness With Breakthrough Technique

    The Huffington Post Canada | By Christian Cotroneo Posted: 09/05/2013

    Researchers say they are very close to unleashing a product that could finally draw the curtain on the dreaded comb-over.

    VERY CLOSE TO UNLEASHING A PRODUCT… Somebody could ask Christian Cotroneo if he really was told that… Very close… unleashing a product… It would be so good if he didn’t create this phrase on his own. If whoever from Follica has told this way it means they’re almost ready to market a treatment. But only Christian Cotroneo could assure us that he was given that answer.

    • McJ

      Likely just media hyperbole. Read nothing into that as Follica would not have said something like that. They’ve been especially careful recently regarding press statements and have not given timelines. Read below in the comments for the last thing they said. It was a twitter response amounting to ‘we’re advancing the development and we’ll let you know when we have news about timelines or updates’

      All you can do is wait and hope for the best, Ignoring media headlines like the huffpost one is for the best as all they want is to attract you with a catchy headline. Very little based in fact.

      • anxious

        That’s why I think he should be asked… then he won’t need to impress nobody, can be sincere and tell exactly what he was told.. I don’t know. The guy is bald and should have an interest himself… maybe he was told that, very close isn’t a timeline, it’s vague anyway, but really promising if it is true. It implies that they’re working in the final steps already, it means they’re probably done with trials and research and are now preparing a market strategy… I don’t know.. I really hope this guy got this information the way he put it down. VERY CLOSE.. PRODUCT…

  • bozo
  • Matthew Poitras

    My personal outlook fantasy:

    Follica indicated they were beginning a new phase 2 with the Fg9 discovery back in November. I’m estimating a phase 2 clinical trial at around 2.5 years, then a phase 3 trial around 3 years. Back to the old 5 year cliche.

    On Sept 17 2013, Histogen said they got a US patent on HSC. The article says they are still testing it. I’ll say three more years of phase 2, then 3 years of phase 3. So about a year after my Follica estimate.

    Then of course Replicel. Shiseido bought the rights a few months back and announced they are just now beginning clinical trials. I’d give them at least 8 years out.

    Latisse is a wild card to me. Their first trial on Latisse failed miserably but they are very rich and very powerful. If upping the dosage works in this next trial they may be another contender but who knows. As of now they have nothing so whatever.

    • anxious

      I don’t know how this guys don’t get that the pathway is that of Latisse, if it works for eyelashes, then if not the same substance, but an analogue or similar should do the same for hair follicles of the scalp. It’s obvious, then study it better, try things, not in rats but in humans, that’s why it takes so long, they use a model that is completely different from man. Rats have fur, not hair for Christ’s sake.. that’s why they never get it right. I’d be a volunteer whenever they wanted, before rats.. send me everything you’ve got and I try them for you suckers!!!

    • Hopeisall

      Follica don’t have to go through the same extensive testing when they are using known and studied drugs. The normal rules do not apply. Although they have only admitted publicly to pre-clinical testing of FGF9, they have been aware of its uses in mice after wounding since 2008;

      http://www.google.com/patents/EP2361119A1?cl=en

      Follica may not be as far out as one might think.

      • j.m

        I really hope this guys save us soon. Not have that much time and need my hair beautiful more than ever.. thanks for remembering this Hopeisall

      • anxious

        That’s what pisses me off… if they know since 2008 why hasn’t they tried this already, in humans??? it’s unbelievable!! that’s why it never happens.. I can’t believe it hasn’t been tested yet, really..

  • julian

    Cotsarelis said 2 to 3 years in 2008.. if all went well… it’s 6 years since then.. obviously all didn’t go well. It’s impossible to know anything. This fgf 9 is known to them since their initial statements, 2008, but they never mentioned it until last year, like it was a discovery. Why they didn’t mentioned it in 2008? why they say it still has to be tested, after 6 years??!! odd!!!! Really strange… don’t know what to believe anymore or if they should be trusted.

    • nick

      i just feel follica will come to market with good final product, make brand new hair , also make weak hair strong again, they say that in there latest patent. march 20 2014

      • Boston

        Link?

        • julian
          • McJ

            I believe Boston has already covered this. I think, and it’s in the discussions below, this is the US version of the worldwide patent or something. Maybe Boston can clarify.

            Hopeisall posted a patent link that I believe you’re referring to Julian, the whole FgF9 thing going back to 2008. I have no idea how these things work so perhaps there’s a reasonable explanation for it. ‘disappointed’ might the person to answer this. Interestingly (or maybe not), the most recent scientist article on Follica…

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

            had a link to the 2008 fgf9 patent in the comments section. That comment no longer appears. Could’ve been scrubbed possibly? In any event, all we can do is wait and keep our fingers crossed.

          • julian

            it’s really strange having this knowledge since 2008 and only publish it in 2013 as it was new and say that it has never been tried, after 5 years, knowing it could make a big difference in the results. I get really sad with things like that. Hope they’re hiding stuff. Why it wasn’t tried yet?? if it was discovered last year ok.. but 5 years ago??? at this pace we will never see a treatment from this company. They don’t care it seems.

          • McJ

            It could well be all some sort of subterfuge type thing – I hope it is! But from everything I’ve picked up over the years following this story and following it on Xconomy with all you folks, it’s likely biology and science and how complicated it is getting from point A to point B…

            It probably seems simple to the lay person but people in the field know the terrain a lot better and the complications that come with that. ‘disappointed’ was great for that type of info, If you haven’t followed his responses on this thread, you should, they’re very informative. I think, given the potential money involved for a truly effective hair loss treatment (and even a hair reduction treatment), they do care. Because whoever gets there first will be rich, rich rich. I’m sure they’re going as fast as they can.

            I personally have found it better not to worry about this as I can’t do anything about it. I’m thankful that a solution is, at the very least, on the horizon. I’m a fairly infrequent visitor these days and I’m happier for it. I get pangs every now and again but I kinda realize that when, and I think it is a case of ‘when’ rather than ‘if’, they do release this to the public, it’ll be front page, six o clock news type of big. So, all I can do is wait and hope Follica are going to surprise us soon. But i totally get the frustration at the same time.

          • disappointed

            Hi McJ – I agree, worrying is not good. Doesn’t speed up anything. Though I hope dissatisfaction by younger generations helps spur change along the lines of dismantling a lot of the red tape or inventing a way for smarter testing reagents before they get to humans (e.g. organ on a chip).

            With regard to the patent status, it could be a few things at play. Number one, if you have a lab discovery and blab about that discovery at a meeting the US is nice enough to give you up to one year post-public disclosure to file a patent but you’ve also, naively, given up your world wide rights to that patent. So better option is to file a patent which might delay things a month or so and then publish or even wait longer to publish if you have raw data to patent ASAP and then another year or more for polished results for a fancy publication in a top journal.

            The patent itself, even from academia, doesn’t have to be work that is ultimately published in a peer review journal, so a discovery that is filed in 08 can take years to be reviewed and then disclosed to the public. When the whiff of that new patent comes out suddenly a “science journalist” picks up on it and tells the world. Not saying that happened here, just that patenting something is not like renewing a drivers license an hour before work.

            The fact that Follica has arguably one of the top hair follicle development people on their board, that guys like Langer sit on their board, funding even in a bad climate. I’d love to see a paper on what’s been accomplished but they aren’t sharing and that makes sense. If word got out that Follica was doing great a company like Merck could decide to compete and crush them. Hopefully, ideally, Follica will release some data and the “me too” mentality among other companies will take hold. Competition would really help those in need of HT.

            The one thing I find amazing is why a hair loss therapy lab that uses e.g. plasma replacement therapy, with the right infrastructure in place, isn’t conducting their in-house kitchen trials.

            Don’t know if I answered your questions. But feel free to post specific ones if you want my two cents. I’ll try to check again this week.

          • julian

            I’d like to know what you think of the chances that Follica is doing great? is their silence a good sign or a bad one, after all this time??

          • disappointed

            The chances are probably in favor of Follica having some positive result. The economy does suck, and unlike the past where a slow death could occur and all the investors money went bye-bye after 5+ years, these days if there are no results forthcoming investors can pull the plug. So there is something there that (and I’m embarrassed to write this) that is making the dumb-as-a-box-of-rocks investors feel there is still some potential to make $$. That’s not written in stone, but my gut feeling. Cots & co., if successful, would be a service company but stem cell/tissue engineering companies are growing in number and successes. I mean really, we’re talking about a target site that is effectively exposed to air. If the original patent of wound healing is broad and easy to defend Follica will have the motivation to move forward while testing reagents that are generation 2, 3, 4 and so on

          • McJ

            Hey disappointed, my first reply got lost somehow. Anyway, thanks for those insights. It’s always good to get your perspective on this.

            I don’t really have too much to add. I think I mentioned in my initial reply that most folks would love some sort of reassurance from Follica that they’re nearly ready to market but that’s gonna happen. I do reckon the next piece of news from Follica might give an indication of what sort of time frame we’re looking at.

            I was wondering though about your last comment regarding the original patent and how broad it is. What does testing the reagents that are generation 2, 3, 4 and so on mean?

          • disappointed

            I know this thread is getting long. So on your question I mean that the initial hurdle may be getting approval for wounding + application of a Wnt protein (not sure, just a guess). Once that method is approved, Follica could be sitting pretty IF the patent is THAT broad — wounding and addition of factor X.

            A patent is not the right to work on anything you want. A patent gives someone the right to block someone else from working on something. So, IF (if, if , if) Follica shows some promise with a system of wounding and adding a protein/drug/virus it would be a nice score. Basically like me having a patent on band-aids. You have an invention that consists of an antibiotic that is soaked into the fibers of the band-aid? Great, but you aren’t selling that unless I get a piece – if you don’t pay, I get a court order and stop you in your tracks.
            Maybe Follica will crash and burn, but if wounding fundamentally improved hair growth vs Wnt alone, now they have a platform that they can plug in drug X, Y and Z etc. and likely with shorter approval times for the 2nd 3rd and 4th etc. drug.

            Something more close to home – if you and I had built a prototype that was a blackberry-style device the size of a cadillac 20 years ago, and we decided we could afford a patent but didn’t have $$ to get manufacturing done, we could just sit on the patent. 12 years later Blackberry is hot and we come along and tell the makers of Blackberry — you have to back pay us for the 7 years you’ve been in business and every year forward until our patent covering the tech expires. If not, we’ll get a judge to shut down your sales. Follica may be hush hush because they need to really secure a patent for a platform, a platform for which 100 drugs could be tested. Ideally a lot of those drugs will be off patent so Follica will be even safer and not have to share, but drugs without that wounding method may only ever be as good as minoxidil.

            Need to get back to work but love to talk shop.

          • McJ

            Genuinely, it’s fascinating to read. I really do appreciate your posts. I think it adds necessary layers to a situation that a lot of people think is much more straight forward than it really is. It certainly not as black and white as it looks

            The whole patent thing is super interesting and you’ve given a great explanation of how something like that works. If Follica ever do make it to market with a truly game changing product, the story of how they got there will be a great read. Fingers crossed.

  • baldtruth

    In 2000 Spencer Kobren published his book The Bald Truth.. it should be outdated by now, 14 years later, but NO… it isn’t since then there was nothing new, it’s the same treatments available, so the book is still the best source of information about baldness and hairless… the slowness of medicine amazes me and it’s understandable.. they take so long, even knowing that a discovery is so promising like in this case of the fgf9, to even start testing it, the process is so damned slow, that it takes an eternity until it can become useful and help the sufferers. It’s really frustrating.

    • disappointed

      1. Who will lead this work, who is the team (are they reliable, can they even reproduce the published work? (e.g. see recent fiasco on STAP cells). It may be that administering the reagent 3 times a day for 6 months shows no improvement, is that the kill point?
      2. How will the human fgf9 be produced? In mammalian cells and under GMP at which facility/company?
      2B. At what cost?
      3. And how often will it be administered and for how many people?
      4. Who owns the intellectual property? If someone at university X does, will they have to take a license to other patented tech to administer the fgf9? Is human fgf9 under a broad patent itself?
      5. What are the dangers/side effects? Any indication that fgf9 may result in cancer? Anyone with hair loss now may not care but I can point you to 1000+ posts of angry people who feel Propecia merely “killed their sex life.” I can assure you cancer is much worse.
      6. Where will the work take place and what is the one year end goal?

      Finally, who will pay for this? A small study with salaries, overhead, etc. could easily run hundreds of thousands of dollars… and that’s just the start. Who will take the risk when they know they are going down a long costly road. Venture capitalists are money managers and biology doesn’t pay off quickly, there is no quick flip.

      Just trying to put it in perspective. Sure, we’d all the department of “throw sh*t to the wall and see what sticks” but until someone like Peter Thiel or others build some kind of Libertarian test site offshore, aint gonna happen.

      • bald truth

        In your opinion what are the chances Follica already knows fgf9 works perfectly in human scalp and are further than they’ve admitted in their trials?

        • disappointed

          I have not read what the absolute latest info out of Follica is. You may have thrown the word “perfectly” in there by accident, but nobody on earth would have a therapy that is perfect, and which all patient respond to equally.

          To get to Phase I you need some proof of concept in a lab (for example, human skin grafted onto a mouse) and then go for Phase I. Phase I is only for safety and if fgf9 is in that trial, as far as I know it would have to be in their investigational new drug (IND) application for the clinical trial.

          I am admittedly curious about what Follica has observed with patients, but they can’t switch gears mid-stream. With fgf9, if there was low confidence/no tests in some mouse model to begin with, it may be left out of trials unless fgf9 applied to human wounds has been approved in the past for other reasons.

          • baldtruth

            Fgf9 is not a drug, it’s a protein, already present in human body. By perfectly I meant it would repeat the results seen in mice, just that.

          • disappointed

            Mesenchymal stem cells extracted from patient bone marrow and injected into e.g. liver to lower cholesterol — Investigational New Drug (IND) application necessary

            T cells isolated from patient blood, modified with a virus carrying a gene, then reintroduced into the bloodstream to attack cancers—- Investigational New Drug (IND) application necessary

            Small molecule/new chemical entity isolated from the flower petals of a dandelion weed and ingested to lower blood pressure — IND application necessary.

            I’m in R&D and away of what a protein is, but any protein utilized for therapy is classified as a drug.

            Results in mice would not constitute perfection, not by a long shot. 50 million years of divergent evolution is why a lot of things that work in mice fail in human. However, mouse tests are what are needed. Even if Follica has results in mice, those might be a far cry from the procedure that will be executed in human. E.g. we aren’t going to make transgenic humans from birth with scalp specific production of fgf9.

  • pissedoffwithmedicinesuckers

    http://www.xconomy.com/boston/2014/04/06/agioss-blood-cancer-drug-shines-in-first-early-test/

    look at that: they seem to have found a very promising maybe almost potential cure for blood cancer BUT… it will be a long road BECAUSE they’re worried about safety, FOR A PERSON THAT IS WITH CANCER.. is there any logic in that? ow no, we won’t give you that cause it may be harmful, dangerous… wow yeah??? more harmful and dangerous than cancer??? really?? So we’ll test it first in mice.. I don’t know, but I’m pretty sure mice also should have been cured from cancer too, and all diseases that you might think of just because nobody cares about their safety.

    • disappointed

      “pissed off with medicine suckers?” Medical doctors and researchers aren’t the ones suing everything in sight, or the ones responsible for the stack of paperwork everyone should have filed by the 15th. The safety concern is there because how much of the drug to give is a black box. Day 1 of testing could have very well resulted in 1/2 of the patients dieing off. Rare, but it happens.

  • McJ

    Something a little different and hopefully a sign of great things in the future;

    http://io9.com/researchers-clone-stem-cells-from-human-adults-1564755314