Hair Loss - Follica doesn't need FDA Approval- Proof of concept involving 15 patients

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Follica doesn't need FDA Approval- Proof of concept involving 15 patients (Hair Multiplication & Research)

posted by SPQR, 14.04.2008, 10:07

» Sorry if this was already posted:
» source:
» http://www.xconomy.com/2008/01/04/gone-today-hair-tomorrow-follica-raises-funds-to-begin-human-trial-of-baldness-treatment/
»
» Gone Today, Hair Tomorrow—Follica Raises Funds to Begin Human Trial of
» Baldness Treatment
» Robert Buderi 1/4/08
»
» Call it a hair-raising event. Follica, a Boston startup out to develop
» novel ways of treating and even curing baldness and other hair-follicle
» disorders, today announced it had completed a $5.5 million Series A
» financing round. The round was led by Interwest Partners of Dallas and
» Menlo Park, CA, and joined by founding investor PureTech Ventures, in
» whose offices Follica is currently housed.
»
» Follica was founded in late 2006 by PureTech and a group of leading
» academics who include Harvard Medical School dermatologist Rox Anderson,
» University of Pennsylvania stem cell biologist George Cotsarelis, and Vera
» Price, director of the University of California, San Francisco (UCSF) Hair
» Research Center. Its primary initial focus is an extremely common form of
» hair loss called androgenic alopecia—aka male pattern baldness or female
» pattern baldness.
»
» Follica has targeted a, shall we say, growth industry. According to
» PureTech’s website, treatments for conditions of the follicle—chief among
» them hair loss, acne, and pigmentation issues—represent a $10 billion-plus
» annual market. It’s all part of the even broader category of “aesthetic
» medicine,” which also includes things like plastic surgery and many
» obesity treatments. And it is really in the recognition of the potential
» of aesthetic medicine that the, um, roots of Follica’s story lie.
»
» Daphne Zohar, PureTech’s founder and managing partner (and an Xconomist),
» says the firm began thinking seriously about aesthetic medicine in early
» 2006. “There’s huge markets, and most of the technologies and things that
» are out there don’t come from real academic science,” she says. “A lot of
» them are this late-night infomercial type of thing.” But the market
» potential is undeniable, and it wasn’t lost on Zohar that people pay out
» of pocket for aesthetic treatments, meaning no health insurance
» reimbursement issues for manufacturers to contend with.
»
» PureTech put together a team of expert advisors to begin looking at
» different aspects of aesthetic medicine. Their survey spanned everything
» from skin rejuvenation approaches to fat melting techniques, perhaps more
» than 100 different ideas in all, Zohar says. “As we were looking, we
» noticed the most interesting things had something to do with the
» follicle,” she says. “The follicle’s almost like the epicenter of human
» hair and skin.” If you can control the follicles and the sebaceous glands
» that are connected to each of them, you can theoretically create new hair,
» stop hair from growing, or even treat acne, Zohar says. “Whatever you do to
» the follicle is going to be beneficial to somebody,” she adds.
»
» Armed with that realization, PureTech put together an even smaller group
» of follicle experts—Price, Anderson, and Cotsarelis formed the core of
» this contingent—to study possible research or technological approaches to
» follicular problems in more detail.
»
» Then, one day, Cotsarelis told Zohar he was working on something in his
» lab that could be just what the doctor ordered. The Penn scientist was
» persuaded to bring that work to Follica, which eventually licensed
» Cotsarelis’s core research.
»
» Cotsarelis, an expert in epithelial stem cells such as those found in the
» skin, was studying how skin heals and noticed that new hair follicles
» seemed to be forming in the middle of some of some wounds. He learned that
» when the skin’s top layers were removed, some cells within the wound revert
» to a more primitive state (what he calls an “embryonic window”) from which
» they can develop into either hair or skin. With more research, says Zohar,
» Cotsarelis found that he “could actually push them to one direction or
» another.” In a widely read Nature paper published last May, Cotsarelis
» showed for the first time that it’s possible to create new hair follicles
» in adult mammals—and to shut down hair growth. He could even grow thicker,
» darker hair.
»
» Zohar says Follica has further developed this work and filed additional
» patents to protect the technology. What’s so beautiful about the approach,
» she says, is that translating it into a treatment for humans involves only
» devices and drugs that are already on the market. A doctor would first use
» a microdermabrasion tool, say, or a laser to remove the top layers of the
» skin—as is already commonly done in a number of dermatologic and cosmetic
» procedures—knocking some cells back into a primitive state. The doctor can
» then use this newly created therapeutic window to inject drugs that push
» the cells to develop along one pathway or another and grow hair or skin.
» Zohar won’t reveal what drugs Follica is using, except to say that they
» are small molecule drugs normally taken orally for purposes with no
» relation to hair growth.
»
» [b]Because the components of the system are
» already approved, the regulatory path is pretty straightforward, and
» Follica can perform human studies without jumping through a lot of
» governmental hoops. That’s exactly what the company plans to do with the
» money it has just raised. A proof of concept study involving 15 to 20
» patients (Follica has no shortage of volunteers, as several hundred people
» sent in e-mails when word of Cotsarelis’s work reached the public) should
» begin in the next few months. The trial has several phases, however, and
» Zohar cautions that final data won’t be in for at least a year. So don’t
» pull your hair out waiting for results.[/b]


very nice... especially in confront of the last info about the research of the ICX TRC, that says that after a research, the FDA approval needs 18/24 months for give a commercial release.......... this means that if the follica study works, FOLLICA could be in the market 18/24 months before ICX..... i'm happy for this


SPQR is located in [NA] and he is available to meet: NO


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