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04 Jan 07
Neosil Announces Positive Phase 2 Data for NEOSH101, an Investigational Treatment for Androgenetic Alopecia
EMERYVILLE, CA -- (MARKET WIRE) -- January 04, 2007 -- Neosil, Inc., a privately held dermatology-focused pharmaceutical company, today announced positive Phase 2a clinical data demonstrating that its lead product, NEOSH101, increased hair growth significantly in men diagnosed with androgenetic alopecia, also known as pattern hair loss (PHL). Androgenetic alopecia or PHL, caused by a combination of genetic and hormonal factors, is noticeable in about 20 percent of the population by age 20 and increases steadily with age. By age 50 approximately half of the U.S. population will have some degree of PHL.*
"Based on the results of this study, we are quite encouraged by the increase in hair growth observed after such a short once-daily treatment regimen with NEOSH101," said Vera H. Price, MD, FRCP(C), Professor of Clinical Dermatology, Department of Dermatology, University of California, San Francisco.
In a randomized, double-blind Phase 2a clinical study, conducted in Germany, 50 men with androgenetic alopecia (Norwood/Hamilton grades III-IV) received once-daily topical treatments of NEOSH101 or placebo over two 14-day treatment periods, which were separated by a one-month drug-free interval. Hair growth was measured using an objective photographic, computer-based analysis for up to 24 weeks after initiation of therapy. Results show that NEOSH101 was safe and well tolerated. A statistically significant increase in total hair count (4.8%, p=0.04), and cumulative hair thickness (3.7%, p=0.02) were observed, with peak effects occurring eight weeks following the second treatment cycle.
"The results of this study are encouraging, particularly the finding of increased numbers of terminal hairs, those hairs that are thicker than 40 microns and desirable for scalp coverage," said Andria Langenberg, M.D., Vice President of Clinical Development at Neosil. "We plan to initiate a Phase 2b study to evaluate daily treatment with NEOSH101 for a longer treatment period in men with PHL."
About Neosil
Neosil, Inc. is a privately held dermatology-focused pharmaceutical company that was funded in November 2004 with a $32 million investment by MPM Capital and Burrill & Company, following initial incubation funding by Shalon Ventures, LP. In addition to its topical hair growth product, NEOSH101, Neosil is developing a broad-spectrum topical anti-microbial agent for acne and anti-infective use.
* Nyholt, D.R., et al.: Genetic basis for male pattern baldness, J. Investig. Dermatol. 121:1651-1564, 2003.
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SOURCE: Neosil
Effect of Hair Cycle Stage
<0175> Skin explants from mice during telogen at 3 weeks of age were cultured for 72 hours, in the presence of proteasome inhibitors, and then the explants were histologically examined. In the untreated control explants, the follicles were few and small. In the explants treated with PSI (50 nM), epoxomicin (25 nM), and the hybrid PSI-epoxide (50 nM), there was an obvious increase in hair follicle diameter, and follicle elongation. Minoxidil also caused these changes, but at concentration s 10,000-fold greater. Since these small follicles resemble the miniaturized follicles seen in male pattern baldness, this suggests these compounds may have the same effects in that situation.