He only looks sad still; he died while waiting for hair

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 trial and 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

Read more about Intercytex and Hair Multiplication on the Tressless Wiki

]]> http://tressless.com/2008/03/17/intercytex-phase-ii-hair-multiplication-completed-trial-results/feed/ 292 http://tressless.com/2008/02/10/the-state-of-hairloss-in-2008/ http://tressless.com/2008/02/10/the-state-of-hairloss-in-2008/#comments Sun, 10 Feb 2008 20:31:41 +0000 Tressless http://tressless.com/blog/2008/02/10/the-state-of-hairloss-in-2008/

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!

Intercytex, a UK-based biotechnology company, released the results from their ongoing ICX-TRC Phase II trial hair multiplication technology today.

To be clear: permanent hair is being grown on bald scalps. No drugs or further treatment is needed to keep the hair. This is the beginning of an absolute cure for hairloss.

From the PDF information sheet:

ICX-TRC consists of a suspension of autologous dermal papilla (DP) cells. These cells are able to stimulate the generation of new hairs when injected into the scalp in close proximity to the epithelial cells which generate the hair. The purpose of the ongoing Phase II study being conducted by Dr Bessam Farjo in Manchester is 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. Two sub-groups were each injected with autologous DP cells using different delivery techniques. The first group focussed on delivery of the hair inductive DP cells, and in the second group resident hair producing (epithelial) cells were also stimulated at the time of delivery. Although it is too early to determine fully the differences between the sub-groups, the preliminary data are encouraging. In the first sub-group 2 patients out of 5 showed substantial increases in hair count (21 & 55%) at 24 weeks. In the second sub-group (5 patients in total) injected more recently, all patients showed substantial and visible increased hair counts at 6 and/or 12 weeks (13-105%). We believe this increased hair production is attributable to the interaction between the injected DP cells and the stimulated resident hair producing cells. A further 8 subjects will be treated with variations in delivery technique. The full data set on all subjects at 24 weeks will be available in the middle of 2008. This detailed analysis will form the basis of further Phase II or Phase III trials as appropriate. At the end of the trial photographic data will be analysed from a much larger area of treated scalp on all subjects at 12 months. Currently 2 patients have been lost to follow up.

What this means:

• There was a large variation in result quality, coinciding with Intercytex refining their technique.
• Everyone that completed the trial grew hair.
• Some patients doubled their hair count in the test area (105%). Other patients, not so much (13%).
• A new trial with 8 patients will begin soon, the delivery technique will be further refined.
• New results will be released in 24 weeks (mid 2008), with images.
• There may or may not be more Phase II or Phase III testing after this.

What we still don’t know:

• The quality of the new hair
• If repeat injections in the same area would yield continual improvement
• What “pre-stimulation” means, which by their account improves efficacy and is the basis of the second leg of their Phase II trial.
• If this new hair is definitely DHT resistant and cycles normally (Likely, but not proven).

So when will this thing come to market?

Depends on how the next leg of the trials go, but Intercytex already has a market-released cosmetic product called ICX-RHY which was greenlit by MHRA, the medical regulatory agency in the UK. It’s quite possible that our beloved hair multiplication technology will receive the same push to market after Phase II.

That said, ICX-RHY may have only made it to market because it’s a new technology that isn’t adequately regulated. There’s a big party-crashing cloud coming in the form of new European legislation called Advanced Therapies Medicinal Products Regulation (ATMP) , which may become law in 2008. This could be seen as either an extra hurdle or as incentive for Intercytex to get to market fast, as any existing approvals will not face the new regulation. (source)

Regardless of any setbacks, when the doors do finally open to a renewable source of hair, you can count on a stampede of bald man-mastodons rattling windows and flattening all life in a mad dash to the lab, wherever that may be. I’ll be the third formerly wooly mammoth from the front.

Read more: Hair Multiplication on the Tressless Wiki