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


#1

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.

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]


#2

» 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.
»
» 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.

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


#3

» » 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.
» »
» » 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.

»
» 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

I’m in a glass case of emotion!!


#4

almost useless to know that at this time… 'cause we don’t know how many chance we have to see the follica treatment, the MOST important thing is a treatment that WORKS ! Even if we could wait 18-24 months more


#5

yes, Benji told us about it.

I was sceptical at first, but hell, they are talking about a few months, not years, and without the fücking bureaucracy.
If it doesn’t work, at least we are just losing a few months of attention.

Go, Costarellis, go.


#6

Phase one at intercytex was about safety. They shot up willing volunteers and waited to see if anyone had a bad reaction. Nobody did, and some of the guys grew new hairs as a side effect. They weren’t even trying to grow hair. Follica isn’t shooting up your head with cultivated, multiplied cells…they are merely dermabrating it and trying to coax your epilithial cells to formulate hair follicles in the regeneration process by blocking epidermal growth factor (skin)…forcing the epilithial stem cells present to make a new follicle instead for protection from the elements which will in turn act as the command center for skin-rejuvination later. This has been observed in animals as they way they heal after wounds (like bites from other animals in fights). If any of the follica lab mice developed tumors or something, you can bet your a$$ they wouldn’t be heading to human trials yet.

In their first trial, Follica intends to use 15-20 men and actually try to grow hair. If they do, proof of concept can be shown to the FDA. Its HUGE that wnt isn’t mentioned in the “kit” patent. Apparently they are going to rely on the wnt that will activate naturally (I guess). So basically they are dermabrating you, waiting about five days, and giving you dutasteride for about a week to ten days, an EGF-receptor blocker for about a week to ten days, a NO agonist and K-channel opener (MINOXIDIL) for a week to ten days, an antibacterial and antimicrobial for a week to ten days, and probably a fiberblast growth factor and one or two more odds and ends that are all legal and used currently. Most of this stuff is over-the-counter, not even prescription. Minox is, Im sure the anti-microbial and anti-bacterial will be.

If it works, great…if not…it will be a while before effective hair “multiplication”.

If several of these men grow quite a bit of hair (thats a huge “if”), and “proof of concept” is shown…I imagine this might be made available pretty soon. Im sure they might want to test another cohort with three or four other mixes for the men to take and see if they can get better results or whatever, but if they have something “pretty good” then there is absolutely no reason to delay. You would not be sacraficing any of your donor area hairs to get this. Even if there were only 20% increases in hairs in treated areas (say they shaved your head and tried it, and thickened up existing hair)…it would be worth it to many.

As Ive said before…I think it gives alot of men a “second chance” to get on finasteride or fluridil or whatever in hopes that they can KEEP this new hair made up front.


#7

I need something that doesn’t require finasteride. My goal is to get off of it. I’m hoping that whatever they come up with, I could at least repeat the procedure. I would rather pay extra $$$ on a yearly (or whatever) basis than stay on finasteride.


#8

Let me get this straight, this can be done anywhere on your scalp, it doesn’t have to be restricted to the back of your head only? In other words, this is not like Acell where you still need to get a hair transplant before/afterwards.


#9

» I need something that doesn’t require finasteride. My goal is to get off
» of it. I’m hoping that whatever they come up with, I could at least repeat
» the procedure. I would rather pay extra $$$ on a yearly (or whatever)
» basis than stay on finasteride.

Worst case scenario, is they strip mine the back of your head for HT donor, and then regrow more donor hair instead of a scar in the back of your head.


#10

» I need something that doesn’t require finasteride. My goal is to get off
» of it.

This is my ultimate goal. I’m so sick of dutasteride (and before that, finasteride). I’m nearing 12 years on this crap, I can’t stand the side-effects. I want to be a man again. Badly…


#11

I don’t know about everyone else, but I’d much rather use the Follica method to be able to STOP taking any Fin/Dut.

I’m surviving low-dose Finasteride right now but it’s lowering my Test levels and my sex drive. It isn’t helping my chronic depression symptoms, either.

Except for the initial two weeks of follicle growth (which are probably disproportionately important with the DHT), I think I’d rather just use topical AAs as best I can, and then redo the Follica method every few years to keep hair on my head.


#12

Says who? a marketing journalist?

»
» 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.


#13

yea … good news ! I believe it will work because Cotsarelis is a real brillant scientist and not a business man. Their product might impose itself as the ultimate cure without having to demonstrate it. Finger crossed … My greatest fear is that it could have adverse effects like cancer that may abort the development of the product, but im confident and from what i’ve read it works ten times better than Trycho … trico-what ? i already forgot …


#14

» Says who? a marketing journalist?

http://www.xconomy.com/author/dzohar

she sounds pretty legit, especially regarding Follica (http://www.puretechventures.com//Content/team.asp?mainPage=team&subPage=board&membername=langer.asp#)


#15

» » Says who? a marketing journalist?
»
» http://www.xconomy.com/author/dzohar
»
» she sounds pretty legit, especially regarding Follica

By the way …Follica has media reference that ICX and ARI reunited would dream of …

http://www.puretechventures.com//Content/newsFull.asp?file=follicanewscoverage.asp&id=291&mainPage=news


#16

In the patent, its mentioned in the verbiage of “non-naturally occuring EGF agonists”, etc.

There are “natural” tyrosine kinease inhibitiors, which are upstream of EGF-receptor inhibition (would end up doing the same thing) like Daidzien, certain catechins, apple polyphenols (I think apple polyphenols action is directly on the EGF receptor).

Do you think this is defensive verbiage in the patent, or do you think the naturals would not work in these cirucmstances. Any ideas?

BTW----every EGF-antagonist in that patent is expensive as all hell and not available without a prescription. Most of the cost of this procedure will be this drug. I seen one that was $2513 for one month. Yikes…no wonder the health care system is in financial arrears. Who could afford that daily w/o insurance…


#17

» Do you think this is defensive verbiage in the patent, or do you think the
» naturals would not work in these cirucmstances. Any ideas?

I can’t see a reason why they wouldn’t work, too.

» BTW----every EGF-antagonist in that patent is expensive as all hell and
» not available without a prescription. Most of the cost of this procedure
» will be this drug. I seen one that was $2513 for one month.
» Yikes…no wonder the health care system is in financial arrears.
» Who could afford that daily w/o insurance…

I know, those drugs are crazy expensive. Leflunomide is the only EGF-antagonist that is reasonably priced (and even that’s not exactly dirt cheap, depending where you get it, and what dose).


#18

So what’s the bottom line? Is experimenting with some Arava pills (Leflunomide) a dumb idea, or not? Any obvious roadblocks?

I already know the arguments for and against experimenting with the Follica process in general. But does anybody have any thoughts about trying that medication (and probably some topical lithium for the WNT part of the deal) specifically?


#19

» There are “natural” tyrosine kinease inhibitiors, which are upstream of
» EGF-receptor inhibition (would end up doing the same thing) like Daidzien,
» certain catechins, apple polyphenols (I think apple polyphenols action is
» directly on the EGF receptor).

If this hasn’t already been mentioned…Related to the above, do a Pubmed search on quercetin and EGF. Quercetin is cheap and already comes in supplement form.


#20

» So what’s the bottom line? Is experimenting with some Arava pills
» (Leflunomide) a dumb idea, or not? Any obvious roadblocks?

Leflunomide does nothing by itself. It needs to be converted to its active form to have any effect. The question is whether the skin has the ability to perform this conversion.