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Reuters report on ICX (Hair Multiplication & Research)

posted by mroiz, 01.05.2008, 02:12

That Reuters report was pretty standard. Here are excerpts from a recent research report:
Piper Jaffray March 25, 2008
ICX-TRC is a cell therapy-based hair regeneration product being developed for the treatment of male pattern baldness and female diffuse alopecia. This autologous therapy uses dermal papilla cells from the base of a patient's hair. These are multiplied over a period of six weeks and then injected into the bald or thinning areas of the scalp. Over the next three to six months, hair regrows from the injected cells which form new follicles. A pilot Phase I trial, which completed in 2005, showed growth in five out of seven patients.

This is significantly greater success than has been seen by any other group to date, the unfolding Phase II data is confirming these results.

The Phase II trial has treated 19 subjects, although 5 have been lost to follow up, subjects were treated with some injections into a totally bald area of the scalp and also with a larger number of injections into a thinning area to assess the use of the product for thickening thinning hair. We believe treatment of a thinning area is likely to be the earliest application of the product, either in patients as the hair thins or as an adjunct to a traditional hair transplantation allowing transplanted hairs to be used to cover a wider area with better coverage.

The Phase II trial had a rolling protocol with different injection techniques and scalp pre-stimulation techniques used. The first six
patients were treated without pre-stimulation whilst the remaining 13 patients had pre-stimulation of the scalp prior to delivery of the
dermal papilla (DP) cells. The trial has a 48 week follow up as this is roughly how long it takes for a standard hair transplantation to
produce terminal hairs, at earlier time points vellus (fine) hairs are more commonly seen. The interim data, announced this week,
shows that at 24 weeks in the 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. In the 5 with pre-stimulation of the scalp who have reached 12 week follow up all had an
increased hair count at 12 weeks, and the 3 who had reached 24 weeks had maintained this increased count. This is very encouraging
data and we watch the development of this trial with interest.
Intercytex does not expect to fund the development of ICX-TRC beyond the current trial. We expect the company to sign a
commercial agreement with an aesthetics company to continue product development. Intercytex already has an agreement with Bosley,
the largest chain of hair transplant clinics in the US, to negotiate distribution rights to the product. However, we believe that ICX-TRC
may also be of interest to more of the aesthetic medicine companies, hair transplantation is currently the third most common cosmetic
procedure for men with 20,473 transplants being performed in 2006 (American Society Plastic Surgeons). The primary hurdle to
increased use of transplantation is finding sufficient hair to transplant; hence the procedure cannot be used in bald or severely afflicted
patients. Although ICX-TRC does require some hairs from the patient the sample required is only around one tenth of that needed for a
traditional transplantation and the cells acquired can, in principle, be expanded indefinitely.

Commercial Strategy for early portfolio: Intercytex has clarified the strategy for each of its products outlining a route to market, either through partnership or direct sales. Negotiations are already underway for ICX-PRO, we expect a partner to be identified post the Phase III trial data. Intercytex also plans to stop spending on ICX-TRC, post the ongoing Phase II trial, and license out for further development. This reduces the cash requirement of the company. We also believe it is likely that Intercytex will partner ICX-SKN, but after completion of the Phase II trial in treatment of basal cell carcinoma.


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