Follica Co-Founder and Team Find New Clues About Male Baldness

1/4/11

Hold on to your toupees. Scientists have spotted a trend in scalp samples from men with pattern baldness that could lead to a new way to treat hair-loss. The discovery hits close to home for Follica, a startup focused on hair-loss treatments, whose scientific co-founder was one of the main researchers behind the new findings.

The new research found that men with pattern baldness have plenty of hair follicle stem cells in their scalps. This might mean that the stem cells, important to hair follicle development, need to be activated in some way to treat baldness. George Cotsarelis, a dermatologist from the University of Pennsylvania and co-founder of Follica, co-authored a paper on the research released today from the Journal of Clinical Investigation. Follica itself did not participate in the research.

Follica CEO William Ju says that the findings in the paper are in line with the rationale for the company’s experimental device and drug treatment for baldness. The mostly virtual biotech firm, which was hatched and incubated at PureTech Ventures in Boston, has been developing a treatment for pattern baldness that stimulates the re-growth of hair follicles by harnessing a natural wound-healing response.

“Our hypothesis has always been that we could harness adult stem cells to grow new hair follicles,” Ju says. “I think what this recent paper shows is that the stem cells are indeed present.”

Cotsarelis agrees. He says that the findings of the research make a treatment to re-grow hair follicles even more plausible than before. Follica is trying to regenerate hair follicles anew, he says, and he and his colleagues show in the study that the hair follicle stem cells are already present in the scalp.

“It made us realize that male pattern baldness is probably not a stem cell problem as far as numbers go, but that it’s more or a problem of activation of the stem cells,” Cotsarelis says.

In fact, the study’s human scalp samples—collected from men with pattern baldness who were undergoing hair transplantations—lacked progenitor cells that help grow new shafts of hair. Those progenitor cells develop from stem cells. So some of the answers about the causes of male baldness might lie in understanding why the stem cells present in guys’ hair-deprived scalps don’t advance to the progenitor stage. The study found no significant difference in the amount of stem cells between scalp samples from haired and balding regions from the same people. Cotsarelis says that further research is needed to understand why this is.

An overseas human clinical study of Follica’s drug-device combo treatment for baldness is under way, Ju says. He declined to share key specifics of the ongoing study, such as where exactly it is taking place, yet he did say that the firm eventually plans to pursue approval of the treatment in the U.S.

“I will say that the trial is being done in a very quality fashion outside the United States,” Ju says. “They are being done under the same standards as one would see in the United States under FDA [oversight].”

Unfortunately, Ju wouldn’t provide a timeline for when a clinical trial of the firm’s treatment might open to those seeking to remedy their baldness in the U.S. But based on the avalanche of comments we typically get on our stories about the startup, it probably won’t have any trouble finding participants when and if it launches a study in this country.

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  • Artista

    Onion and all, on a piece of paper draw out a 1 cm or.4 inch square. In that square take a pen or pencil and randomly make 56 dots within the square. I believe 56 hairs wouldn’t be a bad BEGINNING at all.

  • onionbagger

    yeah sure would be better that total bald ive never had much hair since been bout 20 and lived with it ok till now 37 but what i had left just went so im not asking for a full head of hair just enough to carry on as i was so mybe it would be ok.cheers arista

  • derpdader

    onionbagger,
    are you talking 37 years or months? learn how to write dude!

  • gg hazell

    derpdader he said 37 years…hes hardly 37 months old and posting here

  • Maverick

    looooooooool

  • Caddillac

    PLEASE let follica get through phase II trials! Apparently phase 2 is where most products fail due to unseen safety issues in phase 1 or the “product” is unable to reproduce consistent results.

    I have no doubt if histogen gets this to market even at 57 new hairs er cm/2 as long as it is consistent over larger areas( 171 per 3 cm2 etc)many more companies will piggy back off their research-formula and either histogen or another copycat would have increased results very quickly. The further down the road “we” go the better they will understand how to increase densities.

    ESPECIALLY since year 1 in the market histogen would make like a BILLION dollars profit :)

  • KKwilliams

    I wonder on how they plan on mapping out the injection sites.

    for every cm 2 they would need 25 injection sites and they would need to be spaced with extreme accuracy to produce even results.

    take into account the blood from each injection on top of the fact the injections need to be basically 2mm apart and on top of that the average patient would need literally thousands of injections and some needing close to 10 k injections!

    this post is based off the previous data that growth only occurs within 2mm around the injection site. I guess Im getting way ahead of myself lol. hurry up phase II

  • julian

    KKwilliams… C´mon man, let them do their job, please! you´re kind of worrying with something you know nothing about, like most people here by the way. The time will come and it won´t be long. What matters to us is that Follica or Histogen or both launch their medicine, the sooner the better, hopefully this year or the next or 2013. the way it will be used, how many injections, if they will be on the head or on the butt or whatever, I don´t care. I just wanna see this f** s** on the shelves and that´s it, man!!!

  • KKwilliams

    Julian-
    I was unaware that my post wondering about how they will map so many injection sites will cause Histogen to halt their trials. YOU need to relax.

  • Z79

    In the recent trials Histogen injected the testsites with either 1 or 4 injections and the testarea was about 2cm2 (the photographs we have seen). I would like to add that there could be too much focus on the 57 new hairs, this probably correlates to the amount of hair previously lost. For a correct estimation of number of hair a individual would get we should use the percentage given, which is about 25 percent increase of hairs. So if you at baseline have 100 hairs per cm2 you would gain 25 new hairs and if you have 50 hairs at baseline you would gain 13 new hairs. More likely, I believe, than that everyone would grow 50 new hairs regardless of how bald they are.

  • onio

    so z79you are saying this is not for bald people, so we have to look else where for answers maybe follica?

  • julian

    KK, sorry for that but I think this is the least problem once they have a tested and proven treatment, or cure if you prefer, in hands, don´t you think? Aside of that I think your wonderings are more than welcome, and relevant for the discussion. I´m relaxed, pretty much. I´m not bald, not even close to. I just want more hair cause I´ve lost some. But I completely understand and feel the importance and the value of this medicine, the impact it would have in the lives of so many people and I hope so much that it is about to be available.

  • gmonasco

    I agree that in terms of Histogen, the most relevant metric is percentage increase in hairs, not absolute hair count. Also, all the figures mentioned so far are derived from a single injection of a specified dose — as yet we have no idea of the effects of multiple injections and/or varying dosages.

  • Z79

    Onio that is not what Im sayin. Cause I have no idea how goood/bad the final product will be. Repeated injections could turn a Nw6 to a full head of hair, who knows? When phase 2 is over we will know a lot more. But if it isn´t compoundable then frankly I will be dissapointed. But I hope and believe we will see better numbers in phase 2 than 25%.

  • 4thHorse

    The voices in my head may not be real, but they have some good ideas! Some humor to soften the excitement and tension. Believe it, these are some exciting times…..its almost to a point where you can actually count down the months, and when you get to be my age..47-48, the months go by like days…!! So for me I am really looking forward to 2013…counting the months (going by like days) and counting!!

  • lurker

    Anyone have any idea on:

    1) How would Histogen’s product work around the hairline? Please don’t say you’d get a HT there. That’s not what I’m asking. How would it work if you did NOT get a HT.

    2) I’m assuming each injection covers a certain amount of the head. Therefore, the more bald you are the more injections you’ll need. And as such, I’m assuming the more injections the higher the price, right? So this $5K might just be a starting price?

  • FullHead

    Hello all, im assuming you all recently saw the video on the Today show with Mat Lauer, their on site Doctor said Follica findings were good and consist and that a solution would be available in a few years, or is no one beliveing this info, Mat Lauer asked the questions she answered them from the info she got from Follica, so why all the doubt out there.

  • gmonasco

    Dr. Cotsarelis was on the “Today Show” back in 2008, but I’m not aware of his having been on since then.

  • Mino

    That interview took place years ago. Theres doubt because cotsarelis said something would out to market in 5 years back in 2006 if im right and we havent heard anything about there product in years besides them saying there in some kind of trial phase. Im putting my money on histogen

  • KKwilliams

    I LOVE how informed histogen is keeping us of their progress but by no means have I forgotten or given up on Follica.

    Both companies seem to have no issues raising funds from investors so I think overall these are the two front runners. I agree follica being so secretive sucks, but that doesn’t mean they have hit a wall.

    I am trying to stay positive but cautious :) If histogen has great results in Phase II I think everyone on here will upgrade to booking tickets for asia in advance )

  • onionbagger

    hi. when will phase 2 start ,how long is it likely to run?, and when will we see results of phase 2?, what is phase 3? .can anyone shed some light.and if it is as amazing as we all hope wont there be a queue ten mile long for treatment which will be even longer for us all to wait ?or will enough people be trained up quickly enough to treat the masses? will the treatment remain private or will it go mainstream.?

  • Lurker

    Is there a reason its so slow in here?

  • Herzog

    I’ve posted several things that didn’t show up for some reason.

  • iwantsomehair

    Where is ZZ??? I want him to say something!!!!

  • jordan

    Someone posted here saying that in a few weeks Histogen are going to post some results.. Do we have any info on that?

  • julian

    I wanted Follica to say something, iwantsomehair!! something really good of course!!!

  • ZZ

    Nothing really to add at the moment iwantsomehair. I believe its just a waiting game now to see what kind of results we get from all of the clinical trials. I know it seems slow but its really amazing that there are at least 4 in legit clinical trials and I can sense a real race to the next level. Hard to believe we won’t have some kind of good outcome. Here is what I see:

    Histogen – Most likely next generation treatment. On Feb 12, Ziering said they hope to have initial results from the 50+ injection case studies in 4 weeks…that would be tomorrow but it make take them longer to analyze & release them. Results of the full trial before year end. Somewhat leary that this company doesn’t generate more media buzz and has had a tough time raising cash (Pilot results better than any to date and product selectively targets cancer in vitro.) Some of it could be their lawsuit.

    Follica – Could move quicker than expected if results pan out and they pursue Asia.

    Replicel – This is my “most likely home run”. Strong medical team, no problem raising cash…all after watching a relative goliath of a competitor (Aderans) with a purported huge lead in the trial development process. I sense the kind of confidence that tells me this may have been tried on one of the insiders. Should have already re-injected cell culture in first human subject(s) in February so by mid summer at the latest, they should know what they have. Watching the stock as an indicator of things to come.

    Aderans – Making progress and plugging along but known results to date seem to indicate this may be a slow process.

    S-Equol – This is a substance manufactured internally in a % of the population that eat soy. This % has a lower incidence of prostate cancer and theoretically MPB. It binds to DHT and does not affect serum hormone levels. Two companies have figured out how to manufacture it in a bio-available way (Ausio Pharmaceuticals & Pharmavite). Unclear whether it needs FDA approval although Ausio is in Phase II but not for MPB. This could potentially be available quicker than anything as a maintenance tool.

  • Artista

    Great assessment ZZ and I completely concur. It certainly is a ‘waiting game’ at this point with the potentiality of positive outcomes. I must reiterate the word ‘outcomes’. It does seem to be a ‘race’ of sorts for the ‘Big Four’ and thats a VERY GOOD thing.

  • It’sWhatever

    ZZ, Histogen closed their first round of financing in December with 10 million dollars. They already have investors for the second round of investing, which they hope to raise around 25 million.

    Sounds like they’re doing alright to me.

  • ZZ

    It’sWhatever, I also thnk they are fine now in the short term. I was just making the point that as good as they have appeared to be doing on the surface (as good or better than anyone), raising financing has been a struggle. They extended their efforts to close out Series A way back in February of 2009. They had also hired a firm specializing in soliciting venture funds for bio-tech. I’m not sure they ever recieved funding from that sector. I think they ultimately completed Series A with $$ from 2 wealthy individuals as opposed to a biotech fund that might presunably be in a better position to evaluate the research. I’m sure the Skin Medica lawsuit (they had funding pulled as a result of this being filed) plus the fact that the forerunner to Histogen ran out of cash(Advanced Tissue Sciences, which filed for bankruptcy in 2002 after spending 14 years developing living tissue skin patches)are what have been causing the drag. But their core group seems to have hung together thru this on a shoestring, and for sure, these guys are scrappers.

  • Z79

    Daphne Zohar promises more Follica news to come on her twitter! http://twitter.com/daphnezohar

    This could of course mean a boring “more money to follica” update a year from now, but in my naive mind I hope it will be a awesome clinical trial results within a couple of weeks :)

  • gmonasco

    It was the author of the Xconomy article on this page, Ryan McBride, who promised “more to come,” not Daphne Zohar.

  • Z79

    If he writes an article with some substance I´ll be satisfied as well. We have been loyal followers for so long that we deserve to hear what is going on with Follica, where they are at and what they got to show! So Ryan, get them to talk.

  • julian

    where´s everybody? are the drums drumming for Histogen´s news?

  • happy1
  • ZZ

    Adding to your post Happy1, Tricho(Replicel)also announced the completion of their 2.5 mil private placement:

    http://www.replicel.com/pdf/FINAL-Closing-of-$1-00-PP-March-14-11.pdf

    And for another recap on Tricho, their clinical trial posting:

    http://www.clinicaltrials.gov/ct2/show/NCT01286649?term=androgenetic+alopecia&rank=10

    If you are really bored, scroll thru the 27 different trials listed…they are almost all regarding androgenic alopecia, past and present.

  • Artista

    julian, consider this period of time to be an exercise in patience and perseverance. There are better days ahead.

  • Shooter

    What Artista said.

    No, seriously everyone. Listen to what Artista said.

  • Metsie

    TKL is still at it if anybody is interested
    http://www.tklhairloss.com/index.php

  • Z79

    Follica has a new patent! “The invention relates to intermittent lithium treatments, or a single pulse lithium treatment for modulating hair growth in human subjects. Uses of compositions containing compounds that liberate lithium ions are described, including adjuvants and devices for administration.” http://v3.espacenet.com/publicationDetails/biblio?DB=EPODOC&adjacent=true&locale=en_EP&FT=D&date=20110317&CC=WO&NR=2011031990A1&KC=A1
    This has to be what the ongoing trial is all about. If lithium is what they are going for (not sure if this is the case since other compounds is mentioned in the abstract), what does that do for market approval time? And what does this treatment do in terms of hair growth?? Pictures follica, pictures!! :)

  • Z79

    Btw, in this particular patent Follica is exploring the possibilities of growing new hair with a cream called Lithioderm 8% which is available in France apparently. So if what they describe in the patent actually provides humans with new terminal hair they probably dont need to go through 10 years of clinical trials for market approval…

  • Lazarus

    Trés interessant….

  • Caddillac

    good find Z79

    I have no idea what significance this might have to be honest. Im guessing this stuff might be used after the follica “treatment” and be used to help boost growth in the immediate time after the main treatment in the clinic (cream for at home use kinda thing)

    I really think we are very much in the dark about follica. Im not saying that is bad. It just sucks knowing so little about what they are working on and if they are having success.

    Wow that 10 year number you just threw out there sucks. Is it really possible follica could still be headed for 10 years of trials? Now people are saying histogens earliest release in Asia has gone from 2013 to 2015 now at the earliest. CANT WE CATCH A BREAK?

  • Shooter

    Great, great find Z79!

    The patent itself has me confused, because it essentially starts off saying that the whole Wnt method was too confusing to work properly. The Follica “treatment” is really nothing more than minoxidil and finasteride administered with a fancy Lithium protocol.

    I have no idea how effective this will end up being, but I can say that it would be RIDICULOUS if this was not on the market within two years. There is absolutely NOTHING new, different, or dangerous about this treatment.

    On one hand, I’m a little let down because it seems like “neogenesis” is not occurring after all, and all this treatment does is increase the efficacy of Rogaine and Propecia. On the other hand, there were a few mentions of adding estrogen to hair follicles in order to make them more “female” and, I guess, exempt from balding.

    What do you guys think? Plenty to discuss now…

  • Shooter

    Btw, here’s the whole patent that Z79 posted on another site: http://www.freepatentsonline.com/WO2011031990A1.html

  • Z79

    Caddillac, maybe I was unclear, what I mean is that there probably is NO need for lengthy trials since this cream already is on the market. And laser/dermabrasion is also something u can have done right now. So the protocol in this patent can easily be copied by anyone. But how effective this treatment will be is anyones guess. Maybe it just ends up with vellus hairs. The ongoing trial will answer this Im sure. Whenever that will finish…

  • Z79

    Actually Shooter, they have a very in depth description for a clinical trial where they do mention follicle neogenesis: PRIMARY ENDPOINT
    [00945] In order to assess the efficacy of topical application of lithium gluconate 8% gel on hair follicle neogenesis in dermabraded sites, a generalized linear model (McCullagh & Nelder, 1989) is estimated for the mean number of neogenic-like hair follicles per Day 17 biopsy site.

  • Caddillac

    what the hell!!

    Am I to understand after all the secrecy and silence from follica all they are now looking into is a dermabrasion and then applying an already on the market(for something else)cream and hoping for the best?

    I really hope I am confused. I was under the impression follica was formulating a cocktail based on all the “breakthroughs” that have been uncovered about how to activate stem cells and all that jazz. Wow this is depressing news :(

    I guess its all up to histogen now because i dont see how some cream will regrow a lot of hair on a bald scalp.

    BUT I THINK WE ARE missing information. Theres no way follica would even bother trying to get to market with a already available cream. how would they even recoup their losses?? People would just go get demabrasion and apply the cream themselves I think

  • onionbagger

    yes i agree caddillac its a big blow one less conpetitor in the race,unless they just feel the need to break there silence but really have something alot bigger up ther sleeves(we hope).

  • jordan

    Who said Histogen has gone from 2013 to 2015? Is this a FACT?