Follica CEO Daphne Zohar heads up the publicity with an overview on Xconomy.com:

“Our research has been progressing in a very positive way. We have had significant interest from the venture community and while we just closed the Series A round a few months ago, and weren’t planning on bringing in more money for a couple of years, we recognize that additional funds enable us to move more quickly.

Xconomy finishes up with a seven month old overview Zohar gave:

Daphne Zohar

“What’s so beautiful about the approach, [Zohar] 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.

she then tries to get you into her van without actually giving you any candy:

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.”

Sorry Daphne, but between articles, your application to WIPO already gave the big reveal:

and you thought Hot Pockets were bad. For the record, Gefitinib and Erlotinib are both oral drugs used to treat various cancers.

Interestingly, the WIPO application also discusses a “kit” at length, strongly suggesting that Follica will aim to provide a Do-It-Yourself home applicator:

Any of the above kits can optionally include instructions for applying the composition to the head of a subject (e.g., to the scalp, cheek, chin, lower face, or eyebrow), for applying the composition to the skin of a subject once or twice daily, for applying the composition to the skin of a subject for at least 2, 3, 4, 5, 6, 7, 8, 9, or even 10 consecutive days, for administering the composition during the night, or administering the composition during the day.

Some major questions remain with Follica’s technique, including the quality and the capacity of the new hair to resist DHT. Follica reps appear confident on this issue, but it still remains to be seen. That said, Follica has some heavyweights behind it and we are finally entering an era of hair future-science.

Read more about Follica on the Tressless Wiki

As an aside, have any of you noticed that every single mainstream article is followed up by sentiments regarding how vociferous and eager the hairloss community is?

My story about Follica’s debut last January and its quest for a baldness cure sparked a long-running (440 comments and counting as of this writing) conversation among the startup’s would-be customers that’s still quite lively all these months later.

Joseph Greco, PhD, describes his positive experience coat­ing grafts with PRP as well as placing the gel into recipient sites and the donor area. In a personal communication, Greco told me that he recently saw two patients in whom PRP was used in their transplant 6 months prior. “My first impression was that they looked as though they were at 9 to 10 months rather than 6 months. The transplanted hair appeared more mature, with more aesthetic density than most patients do at that time.” Of course, this is anecdotal data but from some­one with as much as experience as Joe, I have to put some stock in that.

Link to PDF

His first surgery occurred in September 2005. In this instance 5,700 grafts were transplanted to create a free standing hair line, and to fill in the front of his scalp in a natural fashion. All the grafts were derived from his chest, abdomen and legs.

His second surgery occurred in November of 2005. This time the back of his head (crown) was filled in with 3,400 grafts while the large scar on his head were implanted with ~1,600 grafts. All the grafts were derived from his chest and legs only.

Dr. Robert Jones now has access to Acell’s Extracellular Matrix (ECM) products for wound healing. Anyone interested in signing up as a test patient, please email hairsite@aol.com immediately for details.

From Hairsite

Read more about ACell on the Tressless Wiki

Intercytex, the UK-based biotechnology company and hair multiplication darlings of the moment, have released the final results from their Phase II trials for their flagship hair product, ICX-TRC.

The last results were in September, leaving us with extremely promising results and the impression that they were ironing out the kinks.

They appear to have found more consistency this time around, but are oddly backing out of further development and commercial production, saying only that they’ve left the option open for a hair transplant specialist company to swoop in and take over, with Bosley getting first crack.

Hot off the press:

We have now completed the treatment phase of our Phase II study, being conducted by Dr Bessam Farjo in Manchester, to optimise the delivery of the DP cells.

In this study, hair counts are obtained by shaving and photographing a small section of scalp, injecting it and then applying a specialised image analysis system to provide a total hair count. All 19 subjects in the trial have now been treated using a range of injection and scalp pre-stimulation techniques; the first 6 subjects were injected without stimulation of the scalp. In the remaining 13 the resident hair producing (epithelial) cells were stimulated at the time of delivery of the DP cells.

11 subjects have now passed the 24-week time point since treatment and specialised image analysis at this time point showed:

• Of the group of 6 patients without stimulation of the scalp, 3 had an increased hair count and
two had a reduced hair count; one has been lost to follow-up.

• Of the 5 subjects with pre-treatment scalp stimulation, all had increased hair count at 12 weeks and the 3 who were evaluable at 24 weeks all had an increased hair count at that time point.

These data are consistent with the earlier data reported last September and the hypothesis that new hair production is improved by pre-stimulation of the scalp, leading to an interaction between the injected cells and the resident hair producing cells.

24 week data on all subjects in the trial will be available in September 2008 and at the end of the trial photographic data will be analysed from a much larger area of treated scalp on all subjects at 48 weeks.

ICX-TRC overcomes one of the principal drawbacks of conventional transplants which is that the outcome is limited by the amount of donor hair available. By using the Intercytex cell therapy technique almost limitless hair regeneration is possible in a less invasive procedure. Furthermore, treatment can commence early on in the hair loss process with retreatment available in subsequent years. The barrier to commercial success for ICX-TRC is relatively low, being the ability to increase hair count in transplanted or thinning areas.

We believe the continued development of ICX-TRC would best be carried out in partnership with a specialist in the aesthetics field. We do not intend to finance the continuation of clinical and commercial development of ICX-TRC beyond the current Phase II trialand shall seek to sign a partner when we have the complete data package from this trial. Intercytex has granted Bosley, the largest chain of hair transplant clinics in the US, an option to negotiate distribution rights to the product.

Intellectual Property
We have split our cell delivery patent application into three separate applications in the US reflecting additional techniques that are being developed. We have also filed a patent application relating to our
observation that epidermal stimulation pre-treatment appears to enhance hair follicle formation.

Two other previously filed patent applications relating to the method of culturing the dermal papilla cells have been published and are undergoing international examination.

 

What does this mean?

• With pre-stimulation, all subjects grew hair.
• No hair counts were disclosed, which is questionable.
• Intercytex is waiting until September of this year for the final follow-up.
• They are ceasing further testing and looking to license the technology to a hair transplant company.

The big question now is their motivation for stopping further trials and cashing out. We’re left with some ambivalent phrasing: they are ceasing “clinical and commercial development” and cutting in-company financing, but are seeking a very large partner to carry out “distribution”.

It could be a sign of failure: that the technology was not successful enough to turn the profits they had hoped for without further trials, and are rats trying to sell the proverbial ship before it goes under. On the other hand, it may be that no further trials are genuinely necessary, and armed with the successful data, they are looking to pass the baton to someone with the infrastructure to carry out the procedures.

Unless a partnership forms in the meantime, we’ll have to wait until September to see how successful ICX-TRC has been.

Previously: Intercytex phase II hair multiplication trial update

The hide of each animal was excised down to the subcutis, a layer of loose connective tissue beneath surface skin, comprised mostly of insulatory fat. A glass chamber was placed over the wound that held the skin open, leaving only lymph secretion and scabbing to pool over the damage.

The Shope virus was a popular study in most cancer labs. It was discovered in the 1930s and proved with finality that warts are caused by viruses. It was easy to infect the host animal, cottontailed rabbits, and at the time was the only model to study viral carcinogenesis. The excitement over the virus grew to such a fever pitch that it was carried over into human trials, being used on two mentally handicapped German children with a rare genetic disease in what has been billed as the world’s first genetic engineering experiment.

The virus is also thought to be the source of Lepus cornutus, the Jackalope mythology, a kitschy American and Western European icon of an antlered rabbit. If left unchecked, it causes scaly protrusions that branch outward from the animal’s body, sometimes resembling antlers.

There were no antlers in the lab this time, but Breedis had undoubtedly found surprise in a much subtler sort of growth. Publishing his findings in a then 13 year old Cancer Research journal, he noted an unexpected behavior that would be disregarded for half a century: “It is concluded that scar epithelium … is capable of redifferentiating into hair folliclesand sebaceous glands.”

Dr. Breedis had observed the first recorded instance of follicular neogenesis, a phenomenon in which new, fully functioning hair organs develop as a biproduct of trauma to the body.

Articles recently splashed with claims such as “Skin cells have been primed to regrow hair follicles for the first time” (The Guardian), “New Hope For Baldness Treatment: Hair Follicles Created For First Time” (Science Daily), and “First demonstration of new hair follicle generation” (PR release) carried more than a little unintentional hyperbole, but that probably doesn’t bother the accolade’s recipient, Dr. George Cotsarelis. He has rediscovered follicular neogenesis in the very same University of Pennsylvania. It seems the Breedis tomes had been lost to dogma in his own alma mater: “We noticed that after wounding the mice, they developed hair in the middle of the wound,” Cotsarelis said in an interview with ABC Australia, “So we thought something had gone wrong.”

The concept had risen from the ether, just as our would-be Jackelope’s fur had done so many years ago, and the idea that skin cells can be coaxed into transformation is now mainstream and well accepted.

Cotsarelis has led the charge to commercialize the concept this time around. He is listed as a co-inventor on the patent owned by the University, and is a co-founder, board member and advisor in a start-up company called Follica that has licensed the same patent. Cotsarelis also has his hands in Aderans Research, a leading institute in hair multiplication that is associated with Bosley.

It’s been long speculated that our ability to regenerate ourselves was lost somewhere in the evolutionary ladder. In its place, we gained scarring’s quick fix and the infection-fighting powers of inflammation. We do still have some limited regeneration abilities: children before the age of ten can grow back fingertips, an adult’s liver will regenerate itself if enough of the original is left, and ribs are harvested for source material in graft surgeries because they grow back under specific circumstances.

Embryos are another story. Animals, including humans, in an embryonic state will heal almost perfectly when injured within the womb. Around 16 weeks we lose the ability as our immune system begins to rise in power. It had never been conclusively shown that an adult human can regenerate anything near this capacity until very recently.

Damage to the skin activates growth factors which include a class of around 20 proteins known collectively as Wnt. “Wnt” is a concatenation of the Wingless and Int genes, two separate discoveries. Genetic Gemini of sorts, they share parts in a gamut of interactions, from embryo growth to cancer. Duplicity is written into their nature, just as these wounds give rise to new life.

Follica’s plan is to wound the scalp with something akin to dermabrasion, then nourish the skin with unnatural amounts of Wnt, coaxing new hair out of the otherwise dormant skin.

Other companies are taking very different approaches to the same regenerative end.

Last year, an internet forum user named Raptor posting on a hair loss board emphatically suggested “THERE IS ALREADY A PRODUCT AVAILABLE that can help us to restore our lost hair”, but that “red tape must be cut to attain it”. He was referring to ACell, a Maryland-based company with a veterinary product that has been otherwise mired in litigation since 2002. The company now has several FDA clearances and is finally gaining some momentum.

Raptor’s point of inspiration was likely the publicized rehabilitation of injured animals shown completely healed from devastating wounds, including hair that seamlessly crawls across what would otherwise be scar tissue. It was suggested that ACell be applied after cosmetic hair transplants, potentially regrowing hair in the small holes that are left from the extraction site. This would effectively be an unlimited supply of hair, multiple surgeries be damned.

Extracellular matrices, the technology behind ACell’s product, have actually been over 20 years in the making within regenerative medicine. Stephen Badylak first discovered the strange behavior while working a Purdue University lab. From this work, matrices have been used in humans since the 90s in upwards of half a million people. It usually comes in the form of sheet-like patches known as grafts which are applied directly to a wound, internal or external.

An extracellular matrix is the scaffolding that cells are held in and communicate through, though it serves many other functions, including managing growth factors and influencing the development, migration and shape of the cells around it. It’s the supporting cast by which the main actors would have no play without.

The real coup comes when the matrix is extracted and placed locally into a wound site. Signaling molecules go to work, redirecting stem cells to create new tissue, blood vessels, hair, sometimes even new bone. The matrix puts the patient’s wound into an embryonic state. Little known to the patients, the product is actually a mucosal membrane removed from animal innards. A big blanket of sausage casing.

Strangely, even a matrix from a different species yields the same results when placed in a wound. Rejection is said to not be a problem because it lacks the regular cells that are detected and attacked by the host body, and Badylak has been cited as saying that no significant side effects have been found in the decades of research.

The patents were first licensed out for orthopedic use to what is now a division of Johnson and Johnson, but are currently being used in multiple companies with many applications. Cook Group Inc., is one such company, basing its more than 100 products on the technology. Their “OASIS Wound Matrix” product alone is “indicated for use in all partial and full thickness wounds and skin loss injuries as well as superficial and second-degree burns.”

There is absolutely no reason to think this couldn’t be applied to hair transplant patients…

Part II coming soon

More specifically, your Platelet Rich Plasma.

Platelet Rich Plasma (PRP) is a collection of sticky molecules and growth factors extracted by spinning blood in a centrifuge for about half an hour. PRP has been established as a healing agent since the 90s in a myriad of medical applications, including anything from rhinoplasty to coronary bypasses. It beats down infections in chronic wounds, heals poisonous spider bites, acts as a glue in bone grafts, mends muscle injuries, and more or less kicks the shit out of any problem you squirt it on.

A few years ago, a well-regarded Brazilian plastic surgeon named Carlos Uebel started using PRP’s magic sauce to increase the density, growth and success of hair transplants. The extracted follicles are simply bathed in PRP before being placed back into the scalp. Our multi-generational Grecos got hold of this and have been championing the technique in the states, complete with corny instructional videos that look like deleted scenes from Innerspace.

Here’s the twist: will Platelet Rich Plasma improve the quality of your hair without transplant surgery? The Grecos think so, and are conducting informal experiments on patients in their Sarasota office. They inject PRP directly into the scalp, then roll the skin with what appears to be a Dermaroller.

It’s always nice to see doctors in a field as dogmatic as hair transplantation trying something new, and this does fit vaguely with the cell-based technologies of ACell and Follica, but one can’t help see this as eager surgeons playing in a very expensive sandbox. Something else to consider: one of the growth factors abundant in PRP is Transforming Growth Factor Beta (TGFß), which has been implicated in some of the contributing factors in hair loss. How will this effect the outcome?

More from Joseph Greco here

thanks, misterc

Follica’s co-founder, George Cotsarelis, is shown predicting a market release “within a few years” under “perfect” circumstances. It is also confirmed that human trials should begin “within the next year or two”.

Link to video on MSNBC’s page

We had big expectations.

Our pre-millennial pipedreams were always clear; “The Year 2000″ was to be splashed above our lives like a marquee of technological miracles: jetpacks, robot maids, holograms, hoverboards, cure for cancer, cure for ugly, no more woes.

Cut to 2007 and the best we’ve got are iPods, vacuum robots that bump into furniture legs like retarded pets, cars that use a little less gasoline than your 1976 Monte Carlo, and every genetic defect we’ve always had. We’re still a bunch of disgruntled bald guys that can’t do a fucking thing about our shiny pates but ingest pharmaceutical poison and rub lotion on our scalps that smells like burnt condoms. But we can do it while listening to iPods!

I need hairloss with a slow hand

Not much has changed since 1997 when Propecia (Finasteride) forked from its prostate treatment roots (Proscar) to combat baldness. That marked the last FDA approved drug to treat hairloss, and is still only the second product to ever be cleared to this day. The first product, Rogaine (Minoxidil), was approved almost twenty years ago in 1988.

The vast majority of hairlosers attempting to self-medicate will typically stick with a combination of these two, complimented with similarly acting natural supplements and off-label uses of other drugs.

There’s a palpable sense of helplessness that comes with losing one’s hair; this is clear in the adolescent expectations that carry each new treatment forward, a reckless faith that however dubious the source, says this may finally be the thing to free you from your affliction and self-loathing. Every year becomes littered with the remnants of uncertainty, lost hope and disappointment.

Some things are always certain; enterprising cunt wafers entrepreneurs still continuously capitalize on men’s desperation and put out product after product of pseudoscience nonsense that read like the ads for x-ray goggles and hovercraft plans in the back of a boyscout magazine. Here’s a few recent favorites:

• Lasercomb: a device that shoots Deathstar lasers at your head while you brush hope into the space where your hair used to be.
• Toppik: a glitter kit for grown men containing baldspot glue and a salt-shaker filled with black spacedust. Just don’t go swimming. Or lay on pillowcases. Or people.
• Avacor, Folliguard: Why pay $15 for a jug of Minoxidil, the twenty year old drug, when you can pay $350 for what amounts to Minoxidil mixed with elephant toenails and strawberry jam? Nice try, fucking Harry Potter marketeers.

Some success can be found with current treatments. The recurring theme among almost all successful therapies is suppressing DHT, but this will always be a losing battle. Some men have regrowth, some don’t respond well, most just slow down the inevitable. Sprays, creams, pills, shampoo, concealers, hats, hairpieces– it gets to a point where the burden of maintenance and obsession outweighs the trauma of losing your hair in the first place.

On the off-label drug front, Nizoral (Ketoconazole), a drug normally used to treat dandruff in shampoo form, has been a popular additional treatment for hairloss in the last few years. Finasteride’s successor, Dutasteride, is being used for hairloss, but it isn’t the knockout champion as initially hoped. Topical Spironolactone is popular too, and also makes the rounds in the transsexual circuit as a chemical castrator. “I rub anti-man on my head”; quite the conversation starter.

Naturalists tend to concentrate on various antiinflammatories, Saw Palmetto being the main exception, used as a pussy natural alternative to Finasteride.

More extreme experimentalists will go for homemade concoctions and grey market drugs from other countries, like RU58841. A different mixture containing boric acid and requiring a lengthy stovetop preparation was popularized by a Japanese forum user named Waseda several years ago.

In the world of hair transplant surgery, limited donor hair will always be a problem. You’re basically taking evenly distributed hair from one area and putting it in another area, balding Peter to pay Paul. Some doctors have resorted to using extracted body hair, which is great news if you’re Robin William’s knuckles, but probably not so great otherwise.

Hair on the horizon

There’s a joke amongst hairlosers about every good treatment being perpetually 5 years away. For the first time in history, this may actually be an overestimation.

Several companies have been developing techniques to extract the loss-resistant follicles at the back of men’s heads, duplicate the cells, then inject them into the balding areas. This is commonly referred to as Hair Multiplication. True, it isn’t the ideal, which would be a vaccination against your own natural loss, but goddamn if this isn’t good enough. It’s expected to be cheaper than existing hair transplant technology, but there are still some unknowns about quality.

Leading the pack is Intercytex, a UK-based biotechnology company. They released the results of their phase II trial recently. Make no mistake about it; this is an exciting time. Not exciting in the sense of not looking like “that bald asshole” to the women across from you, but exciting in that we can see a finite amount of time left until that is obtainable.

Stay tuned!

A patent dug up from 2001 outlines a method to reduce or reverse hair loss by injecting the scalp with Botox.

Two Toronto, Canada-based doctors named Marvin Schwartz and Brian Freund claim the following:

Injection of (Botox) improves the tissue environment surrounding the hair follicles by reducing scalp tension and, by doing so, improves bloodflow through the arteries. In turn, the tension in hair-bearing tissue is reduced and hair growth is stimulated.

and that you’re losing your hair because of your trampoline:

The anatomy of the scalp can be conceptualized tension-wise as trampoline-like. Over the scalp area, the layers beneath the skin are an unyielding fibrous layer called an aponeurosis (galea aponeurotica). The muscles surrounding the scalp (..) are analogous to the springs which would tension and hold taut the tarp of the trampoline. Blood vessels carrying oxygen and nutrients must traverse this area to provide a suitable environment for hair follicles to flourish. When the muscles surrounding the scalp tighten, the areas of scalp mechanically under the highest tension are the vertex and frontal areas. Thus, the most common areas of male pattern baldness correspond to the areas under highest tension. The inventors have found that by reducing the tension of the musculature surrounding the scalp, tension in tissue of the frontal and vertex areas is also effective reduced. This reduction of tension (..) permits an increase of blood flow into that area of the scalp.

The doctors seem like Botox believers in general, suggesting it be used for whiplash, headaches and oral surgery. Some lucky bald guy with an overbite that fell off a ladder recently is in for a treat.

Reportedly Germans have been doing it for a year with some unimpressive results, but have hope: some other Canadians on the opposite side of the country may have better luck in a trial that was scheduled last January.

link to patent

thanks, superfred