Hurdles for FOLLICA

Stem cell; cell based hair therapy
1

I have always felt that ICX was not a viable option for me. The whole technology is based on the condition of cells obtained from your “old” donor. IOW, since no donor area is completely resistant to DHT minituarization,(some to a worse degree than others), I held out slim hope for this technology… at least in my case. Follica on the other hand, will as I understand it, generate brand new hair…like you’re starting out from the beginning again. DHT resistant? I don’t know, but I heard if you treat it at an early enough stage you maybe able to stave off the effects.

So to the premise of this question. Does anyone know what are the main hurdles that Follica are trying to over come at this point?

2

n/t

3

I wouldn’t count ICX out of the game just yet.

Follica’s hairs might theoretically end up shrinking pretty quickly depending on the specifics. Balding hairs don’t only produce each cycle smaller than the last one, balding hairs can even miniaturize some amount within a single cycle.

We just don’t know enough about the Follica situation right now.

I could imagine us ending up with a combination of Follica’s method and ICX’s method. Use Follica’s method to re-create your severly balded areas, and then use ICX-TRC to stabilize your whole head against long term MPB damage. That would probably be the best of both worlds.

And for all we know, ICX-TRC cell injections into the back of your head might also hold the potential to increase the DHT-resistance of even the donor areas.

Maybe just dumping more DP cells back there will help, even if they’re not significantly different than the others.

And Maybe eventually ICX’s research could lead to them identifying and picking out the few most DHT-resistant DP cells among all the donor area DP cells, for replication & injection.

4

» I have always felt that ICX was not a viable option for me. The whole
» technology is based on the condition of cells obtained from your “old”
» donor. IOW, since no donor area is completely resistant to DHT
» minituarization,(some to a worse degree than others), I held out slim hope
» for this technology… at least in my case. Follica on the other hand, will
» as I understand it, generate brand new hair…like you’re starting out from
» the beginning again. DHT resistant? I don’t know, but I heard if you treat
» it at an early enough stage you maybe able to stave off the effects.
»
» So to the premise of this question. Does anyone know what are the main
» hurdles that Follica are trying to over come at this point?

Can someone give me a quick summary how Follica works? Is it a US company? Are they in human trials?

5

If Follica can merely work in the donor area, one could either thicken up their donor area with hair, and then transplant it…or get a FUE transplant, then do the Follica procedure back there to rebuff the donor area.

I dont know if the regenerative stem cell capability of the donor area will allow for it to be perfomred two or three times, but if it could just “do it” twice…thats alot of hair with a donor area with natural thickness left. It would represent a de facto “cure” for baldness

What follica does in a nutshell is dermabrate the skin…allow for the skin to re-epilithialize (about 3-5 days for human skin, and not the 9 that it takes for a mouse), apply wnt protiens—especially wnt7a, and some other more exotic growth factors and stimulants and an epidermal growth factor inhibitor. It grew human hair on human skin grafted onto a SCID mouse…and has regrown very thick mouse hair. They are about to go to human trials. The “procedure” would take about 12 days to complete. They want to depilate, wait three days, dermabrate, wait 3-5 days and start putting their topical which will be wnt protiens, anti-androgens, egf-receptor blockers, FGF, NO mimetics, minoxidil and a few more exotic things on the abraded area until 9 days after the wounding date. Thats it. Ive seen two pictures of the mice, and it grew the hell out of their hair. It even grew hair on genetically bald mice that arent’ supposed to have any hair. We will see, they have been on NBC with Matt Lauer which is a hell of alot more than Aderans has even been willing to do…so they feel very confident as did NBC’s medical corrspondent “three years or less”----is what she said.

6

» corrspondent “three years or less”----is what she said.

Finally, something other than “within 5 years” :stuck_out_tongue:

7

» » corrspondent “three years or less”----is what she said.
»
» Finally, something other than “within 5 years” :stuck_out_tongue:

http://video.msn.com/video.aspx?mkt=en-US&brand=msnbc&vid=3b251041-8028-403d-a6fc-e749264afc01

watch the interview with Matt Lauer and see her (Snyderman) say it herself. She really is a doctor by the way…and not a mere journalist.

8

» » » corrspondent “three years or less”----is what she said.
» »
» » Finally, something other than “within 5 years” :stuck_out_tongue:
»
»
»
»
» http://video.msn.com/video.aspx?mkt=en-US&brand=msnbc&vid=3b251041-8028-403d-a6fc-e749264afc01
»
»
» watch the interview with Matt Lauer and see her (Snyderman) say it
» herself. She really is a doctor by the way…and not a mere
» journalist.

Anyone know the follica website??

9

http://www.puretechventures.com/content/portTest.asp?file=follica.asp&id=122&mainPage=portfolio&subPage=aboutUs

About Follica

Follica, Inc. is developing novel therapies for the treatment of conditions and disorders associated with the hair follicle, the “master” control center for the development and replenishment of human hair and skin.

Follica co-founder, Dr. George Cotsarelis, recently published research relating to Follica’s technology in the scientific journal Nature. For some of the media coverage around that paper and discovery, www.puretechventures.com//Content/newsFull.asp?file=follicanewscoverage.asp&id=291&mainPage=news

Dr. Cotsarelis was also interviewed on NBC’s Today Show in January 2008. Please click on the following link to view the webcast: http://video.msn.com/video.aspx?mkt=en-US&brand=msnbc&vid=3b251041-8028-403d-a6fc-e749264afc01

Treatments for conditions of the follicle, primarily hair loss, acne, and pigmentation issues, account for a total market exceeding $10 billion annually, despite a lack of truly effective solutions. Follica has assembled a world class team of scientific, clinical, and industry experts that will harness the recent advances in epithelial cell biology to identify and develop novel therapeutic approaches to these disorders.

Multiple forces are converging to create broad opportunities for new treatments of conditions of the follicle. In 2004 hair and acne investigators, including Follica advisors, published breakthrough work elucidating follicle biology [i,ii] . At the same time, consumers and physicians alike are embracing aesthetic medicine at an unprecedented rate: The number of U.S. aesthetic/cosmetic surgical procedures increased from 2.1 billion in 1999 to 8.3 billion in 2003 [iii], and last year patients spent $12 billion worldwide on cosmetic surgery and facial rejuvenation [iv]. Existing treatments for follicle disorders like hair loss and acne have issues with efficacy, safety, or both, and the development of new treatments has not kept pace with this increased appetite for aesthetic treatment.

More information - clinical testing
If you are interested in clinical testing if and when it is announced, please send an e-mail with your name and contact information to
----the email link for this didn’t send, you will have to go to their website if you are interested in participating in their trials.
i Morris et al. Nature Biotech. 2004; 22:411-17.
ii Tumbar et al. Science 2004 :303 :359-363.
iii American Academy of Aesthetic Plastic Surgery
iv Cosmetic Surgery News

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Technology

BACKGROUND: FOLLICLE BIOLOGY AND ITS ROLE IN SKIN

The follicle is an intricate tissue structure composed of numerous coordinated sub-structures (Figure 1). The cylindrically shaped hair follicle is composed of epithelial cells. The apocrine and sebaceous glands control sweat and sebum (lipid secretion) production respectively. Sebum plays a primary role in skin integrity, microbial defense, and the pathophysiology of acne.

The bulge structure housing the epithelial stem cell niche lies below the sebaceous gland. This population of cells controls the initial development of the follicle along with the different phases of the hair cycle. The “hair bulb” contains the dermal papilla and the pigment-generating melanocytes as well as other cells that modulate the hair growth cycle. The follicle is integrated into the surrounding skin through connections to the microvasculature and the sensory nervous system. The interplay among all of these sub-systems influences almost all aspects of skin biology, from inflammation and immune response to the neuroendocrine system.

FOLLICA’S TARGET INDICATIONS

Follica’s primary focus is a novel platform technology for treating hair loss and unwanted excess hair. As a secondary focus, Follica’s will target the other high potential areas related to the biology of the follicle, namely acne, degenerative skin disorders, pigmentation, and body odor.

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Team

R. Rox Anderson, MD, Co-Founder & Chair of the Scientific Advisory Board
Dr. Anderson has been a leading innovator in the medical laser field for over 20 years and several of his 41 issued patents have been developed into products currently used in the clinic. In his capacity as a Professor of Dermatology at Harvard Medical School , Dr. Anderson serves as the Director of the Massachusetts General Hospital Laser Center and the Director of the Wellman Laboratory of Photomedicine. Dr. Anderson is a Board Certified member of the American Board of Dermatology and world renowned thought leader that has published over 160 peer reviewed articles and has been a contributing editor to over 21 textbooks on the medical applications of lasers. Dr. Anderson also has experience advising numerous dermatology companies on how best to translate promising research into clinical products.

George Cotsarelis, MD, Co-Founder & Scientific Advisory Board Member
A pioneer and foremost expert in epithelial stem cell biology, Dr. Cotsarelis’ research led to the isolation and characterization of the expression pattern of stem cells from the bulge region of the follicle. Dr. Cotsarelis is an Associate Professor in the Department of Dermatology at the University of Pennsylvania and has an active clinical practice at the hospital affiliated with the university. He has published over 40 peer reviewed journal articles and has several issued and pending patents based on his scientific discoveries. Dr. Cotsarelis is also an active advisor to dermatology companies developing novel approaches to treating hair loss.

Vera Price, MD, Co-Founder & Scientific Advisory Board Member
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 , the Hair and Nail Clinic, and the UCSF Dermatology Faculty Practice. Dr. Price is Founding Chairman of the National Alopecia Areata 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.

Ron Cape PhD, Board Member [ click here for complete bio ]
Daphne Zohar, Founding CEO, Board Member [ click here for complete bio ]
Chris Ehrlich, Board Member; Partner at Interwest Partners [ click here for complete bio ]
David Steinberg, Chief Business Officer [ click here for complete bio ]
Stephen Prouty, PhD, Director of Research [ click here for complete bio ]

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© Copyright 2006 PureTech Ventures

There is an email link to their clinical trial section if you are interested. They are about to go into trials at Follica with people (not human skin grafted onto a mouse).

10

I think the biggest hurdle for Follica is to show that it actually works with humans. Working in mice is one thing, but is pretty much meaningless as far as whether it will work with humans. The cure for hairloss as well as cancer and about any other disease you can think of has been found in mice first, only to later find that it didn’t work with humans. I wouldn’t get too excited about Follica until there is actually evidence that it works with humans.

11

» I think the biggest hurdle for Follica is to show that it actually works
» with humans. Working in mice is one thing, but is pretty much meaningless
» as far as whether it will work with humans. The cure for hairloss as well
» as cancer and about any other disease you can think of has been found in
» mice first, only to later find that it didn’t work with humans. I
» wouldn’t get too excited about Follica until there is actually evidence
» that it works with humans.:smiley: BUT ALREADY HE WAS PROVEN THAT IT GREW HAIR IN SKIN HUMAN BEING APPLIED IN RATS…HAIR IN SKIN HUMAN.:wink:

12

If true, that’s a good step. But actually seeing it work in humans is the important step.

13

Example 7 in their patent, but of course you haven’t read that.

Getting in vivo human hair growth is the challenge. The only thing that might interfere with it is the human immune system. Everything else in the SCID model is pretty equivalent to human circumstances

14

» but of course you haven’t read that. CLEARLY… if IT WAS MADE IN HUMAN BEINGS WOULD BE BEATING to the MARKET THIS WEEK. ALREADY WAS PROVEN THAT IT GREW HAIR IN HUMAN SKIN APPLIED IN RATS…IN RATS…:wink:

15

Again, I said it was a good step. But it is not the same as getting it to work in an actual human, as even you just stated. Once that is done, then it might be worth getting interested in.

16

» Again, I said it was a good step. But it is not the same as getting it to
» work in an actual human, as even you just stated. Once that is done, then
» it might be worth getting interested in.

yeah, mice grow hair even on vitamins, immuno suppressed mice grow hair even better. there are hundreds of treatments that grow thick hair on these creatures and none of them works even close to the same in humans.

perhaps this could be different but most probably it will be just another false hope.

Do not stall your life for another 5 years to find out.

17

» Getting in vivo human hair growth is the challenge. The only thing that
» might interfere with it is the human immune system. Everything else in the
» SCID model is pretty equivalent to human circumstances

Can you please elaborate Benji? What substance are they toying with in an application to the wounded skin to get the wnt signals excited… and why would it interfere with the immune system? Also why do you think this is only applicable to the donor. Thanx. I’m just an ignorant biotech dude.:slight_smile:

18

» » Getting in vivo human hair growth is the challenge. The only thing that
» » might interfere with it is the human immune system. Everything else in
» the
» » SCID model is pretty equivalent to human circumstances
»
»
» Can you please elaborate Benji? What substance are they toying with in an
» application to the wounded skin to get the wnt signals excited… and why
» would it interfere with the immune system? Also why do you think this is
» only applicable to the donor. Thanx. I’m just an ignorant biotech dude.:slight_smile:

If this website (HINT DAVID) had a feature to whereby you could check all of my old posts, you could easily see the ones that Ive written about Follica, but since I type about as fast as humanely possible, I’ll write a short summary for you.

It was found late in the 1950’s while researching something else about animal skin, that hair on wounded animals (rabbits) would seemingly regrow after the animals skin was deliberately wounded. A few researchers got excited about this new growth, but an asswhole named Dr. William Strahlin wrote a paper without even doing one fukkking test of his own stating that the new hairs had simply migrated in from the periphery of the wound as the skin stretched to heal over the wound, and was taken as gospel for the next sixty years.
Dr. Albert Kligman noted in The Archives of Dermatology back in the 1970’s that he thought he seen some de noveau hair growth on the faces of some acne dermabrasion patients (dermabrated to soften the appearance of acne scars). George Cotsarialis noted that mice deliberately wounded grew new hair in the injured area. They even noted that genetically hairless mice would grow hair at wound sites where a pathway called wnt was overexpressed. These mice didn’t have any hair whatsoever before as they were genetically hairless…therefore the combination of injury plus wnt protiens (wnt7a being the important one) seemed to make brand new hairs grow.
A company has bought the rights to Cotsarialis find from his research at the University of Pennsylvania where Albert Kligman is his colleague.

In tests at Penn, many mice have had areas of their backs dermabraded or CO2 lasered and its been noted brand new hairs form in response to these injuries. Its been noted that the epilithial layer of their skin has to be removed for them to form hairs. Its been noted that the addition of WNT protiens make much much more hair grow (about 14 to 1) over just wounding alone. Its also been noted that by blocking epidermal growth factor receptors with some very expensive drugs, that even more hair is grown—very thick new hairgrowth of white, unpigmented hair. Mice have no pigment in their skin, but humans do---------so the new hairs we might form will almost assuredly have pigment.

In one experiment (experiment 7 in their patent) they grafted some human scalp skin obtained from a hair transplant patient to a back of an immunodeficeint SCID mouse, and abraded it. 7 days post abrasion…the little guy had human hair germs in the human skin on his back, proving this can work in human skin.

They have been testing many different compounds to augment the hairgrowth, and other techniques to enhance its efficacy. A few things that they have found are that by plucking out the hair that is present three days before abrasion and getting all existing hairs in anagen gets a better result. They have found wnt7a being present gets a much much better result (14 to 1 or therabouts), they have also found that by blocking epidermal growth factor from after the re-epilithialization period (which is about 9 days for mice, but apparently 3-6 days for people) also enhances the success. Many other things are mentioned as “enhancements” in the patent to be applied after the skin is re-epilithialized days after the wounding takes place in the patent like anti-androgens, Nitric Oxide agonists, beta catenin, Fiberblast growth factor, even minoxidil and bits of various DNA and a few other exotic things.

They will be starting human testing soon and even have a place on their website for people interested in being in their human trials to apply to.

The reason I mention cyclosporin is this-----------Its been noted before that vellus hairs from MPB-men have been moved to immuno deficient mice and they regrew as well at 22 weeks as donor area hair also transplanted to the mice, showing conclusively that the immune system must have some big part in suppression of these hairs. We dont know the androgen levels of those mice, but even castrates dont grow back vellus hairs. If Follica didnt’ have in vivo success, I was wondering whether someone could get on cyclosporin, an immnosuppressant for the nine days or so while the hairs were forming, and then get back off of it. However…I really think they might have good success in donor area scalp.

I do not know how the thinner bald scalp, missing the water layer and fatty acid layer that it dow, will do in producing new thick natural hairs. I hope it does well…however I do expect the donor area scalp to be able to make new hair because there is no real reason for it not to be able to. If it can, we can re-thicken up the donor area after FUE transplants, and perhaps transplant again…thus “making” more donor area hair. Its a big concern that the hair “made” in frontal scalp might have the same genetics that the hair that miniaturized there had–i.e.–baldness genetics. However, if anti-androgens are taken during the process and certain genes “blocked”, who knows, maybe MPB-resistant hair can someday be made right up front.

They are supposedly going to be in trials soon with human beings.

Here is an televised interview on NBC with Matt Lauer,http://video.msn.com/video.aspx?mkt=en-US&brand=msnbc&vid=3b251041-8028-403d-a6fc-e749264afc01

In the interview, Dr. Nancy Snyderman, NBC medical correspondent states she thinks this could be available in 3 years or “maybe sooner”.
Im just hoping it works in donor area scalp or can thicken up existing hair a great deal to make it available for transplantation personally, but if it can make hair grow on bald scalp…thats great. It would give a man a second chance to get on finasteride and to keep it.

19

» If this website (HINT DAVID) had a feature to
» whereby you could check all of my old posts, you could easily see the ones
» that Ive written about Follica, but since I type about as fast as humanely
» possible, I’ll write a short summary for you.

Click your name near the top right hand corner of your screen and you will see the SHOW POSTS option.

20

» » If this website (HINT DAVID) had a feature to
» » whereby you could check all of my old posts, you could easily see the
» ones
» » that Ive written about Follica, but since I type about as fast as
» humanely
» » possible, I’ll write a short summary for you.
»
» Click your name near the top right hand corner of your screen and you will
» see the SHOW POSTS option.

Thank you David…I did not know that, and apparently MPB didn’t either. :slight_smile: