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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  • Shooter

    Fullhead, that’s great advice.

    tk, HAHAHAHAHAHA! I hate that stupid song!

  • VictimofDHT

    Thanks lowlow. Yup. 5 HTs are torture but to know that they’re going to be for nothing is even more so. I don’t think there’s a word that can describe how I feel now.
    Yeah, it really suck that in 2011 we still don’t have a cure for this curse called baldness. I mean they can change the sex of people but they can’t grow hair !! WTF !

    If Histogen is actually successful I’ll be flying to Singapore the next day. There’s no question about that. I actually was wondering if they were looking for subjects to do their experimentation on. I wish I would’ve known about this before.

    Fullhead, easier said than done.If it were that easy nobody would be suffering in this world. Somethings you can control and somethings you can’t. Unfortunately for some of us the psychological effects of losing hair are devastating and even paralyzing. If you are lucky enough to be one of the people who aren’t affected to the same degree some of us are then that’s good for you. My brother doesn’t give a damn about losing his hair. I wish I could say the same thing about me but the simple fact is that every body reacts differently to certain things in life.

  • rev

    HSC Question & Answer Session with Histogen CEO Dr. Gail K. Naughton
    —————————————————————————–

    Q: The Phase I/II clinical trial of HSC will begin in Singapore this Spring. How will the design of this trial differ from the pilot clinical trial?

    A: Like the pilot trial, the Phase I/II will focus on safety and efficacy in the application of HSC as an injectable for hair growth, but this trial will also begin to examine dosing and delivery. As such, the trial design includes a larger number of injections per treatment site, as well as a second treatment timepoint, to determine if this further enhances the results.

    In addition, the Phase I/II will be a dual-site trial with a larger number of subjects (50), which will provide us will more significant safety and efficacy data.
    —————————————————————————–

    Q: Why has Histogen chosen to perform this clinical trial in Singapore? Will there be trials in other countries as well?

    A: A number of countries in Asia, including Singapore, have become leading global centers for advanced aesthetic medicine. By performing the trial in Singapore, we are able to work with experts in the hair restoration industry while pursuing opportunities to bring HSC to market sooner.

    After a successful Phase I/II trial, we plan to conduct a 250 patient study in 5 countries in Asia, which can lead to Pan-Asian (excluding Japan) approval.

    Regulatory requirements for clinical trials and approval in Singapore and Pan-Asia are very similar to the US and Europe, and their regulatory agencies are highly regarded worldwide. Histogen continues to work with the FDA in parallel to the Singapore trial, and hopes to be able to utilize the data gained from the Phase I/II within its US FDA Investigational New Drug (IND) submission.

    Future clinical studies of HSC in other countries are also likely. We look forward to getting the upcoming trial underway, and to further evaluating potential design and locations for studies including a pilot evaluation of HSC for diffuse hair loss in women.
    —————————————————————————–

    Q: How does HSC work?

    A: When grown under proprietary conditions of very low oxygen and suspension, human newborn dermal cells act as they would in the embryonic environment, becoming stem cell-like and producing proteins that are embryonic in nature. The soluble complex of cell-signaling proteins produced through this process becomes HSC.

    HSC contains a number of proteins, including follistatin, VEGF and KGF, which have been shown by leading research to be involved in hair growth, maintenance, and in the development of new hair follicles. These proteins signal existing follicles to produce new hair, and stimulate stem cells in the scalp to become brand new hair follicles.
    —————————————————————————–

    Q: How does Histogen plan to bring HSC to market?

    A: As with all of its product applications, Histogen seeks to bring HSC to market through partnerships and licenses with global industry leaders. While HSC continues to be Histogen’s lead product application, the embryonic-like soluble proteins and insoluble extracellular matrix produced through our technology process have numerous therapeutic applications. Research to date in areas such as cancer and medical device coatings have yielded very exciting results, and Histogen’s expertise lies in the development of products to meet medical needs.
    —————————————————————————–

    Q: Histogen has recently opened a Series B financing round. What will this financing be used for, and who are Histogen’s investors?

    A: Histogen’s $23M Series B round of financing was opened in December 2010, and will be utilized to fund clinical trials of HSC through market launch in Asia, continue development of our oncology program, and upscale manufacturing to meet regulatory requirements and future commercial needs. As with our first round of financing, Histogen is seeking a limited number of accredited investors for the Series B, which we hope to bring to a close this Spring.
    —————————————————————————–

  • Artista

    Rev,
    Since that interview, the clinical trials had been pushed back to the Fall of 2011 if im not mistaken. Thanks for the posting. This reminder will bring some comfort to those here that have been sitting on the edge of their seats. Chin up ‘Victim’, you will have your day.

  • rev

    hmmm. I thought the trials were pushed from early February to late May.

  • Artista

    Rev you may be right.
    We need clarification on this

  • A

    Trials are in May.

  • tk

    I thought they had already started trials. Where does that 57 hairs/cm2 number come from?

    It’s exciting that they will also test the cumulative effect of repeat treatments. I think that it might be the most important aspect of the trials. If it works, then the only thing standing between you and a full head of hair is money and time.

    2 years isn’t so long guys. Start saving now!

  • c

    Hi,

    how much hairs/cm2 you get with transplants?

  • VictimofDHT

    Thanks Artista.
    Hopefully we hear good news soon.

  • Maverick

    @VictimofDHT

    I am not trying to be “smartypants” but have you considered the possibility of trying that new Acell Matristem? So far I have seen that it does wonders with scars and donor non DHT affected hairs. Even that Rassman dude who is really hard on all new inventions, experiments with Acell, Bernstein too. I know this is maybe not too much, but I believe that you can at least do some research about it(if you haven´t already). Heads up.

  • hairpaper

    Does anyone have the links to Histogen’s key patent(s)?

  • VictimofDHT

    Maverick, I don’t even know what that is. What’s that supposed to do ? I just did a little bit of reading on it and wasn’t really much to that stuff. It helps with the scar in the donor area or something.

    Any word yet from Histogen ? Should we be expecting some news this May ?

  • ZZ
  • Artista

    Good article ZZ.
    About this statement~”Though the company has said it’s doing human testing overseas..”
    I dont remember ever hearing that FOLLICA declared that they have been testing overseas as well. Of course one could assume that it was going on but here is a statement of fact. As i have said, they most certainly are keeping their cards very close to their chest.

  • ZZ

    Artista, In the article at the top of this blog dated 1/4/11 it says “An overseas human clinical study of Follica’s drug-device combo treatment for baldness is under way, Ju says.” What I like most about this new piece is that it appears that they are working at this from several angles at the same time: “We have a variety of programs, both pre-clinically and clinically, to investigate how we can get hair to grow”.

  • Artista

    Oh my,,i overlooked that segment or forgot all about it. Thanks ZZ for pointing it out. They,Follica, are very busy it seems. More so than most thought.

  • Lowlow

    Hmm… ‘a variety of programs’. That, to me at least, does not sound very encouraging I’m afraid. Please don’t accuse me of being overly negative; it is just that I had hoped that Follica were more clued in and following a definite line. That’s why I presumed was the reason they were being so quiet and cagey. I know that it could be argued that with a variety of programs they may eventually make progress with one but it also smacks of uncertainty to me and that they are not sure in which direction to concentrate. Me not happy:-(, but I hope I am very wrong!!

  • VictimofDHT

    Come on guys, it’s been a couple of days and no one has said anything.

  • rev
  • Pingback: Hair-Raising Follica Study Could Point to Baldness Therapy | Xconomy

  • Amy Gorden

    I hope they do find a cure for male pattern baldness, i know a lot of people could benefit from it. http://about-hair-loss.net/