BUSINESS WIRE; Monday February 2, 8:04 am EST
"Female-controlled prevention of HIV disease is an important yet underserved area of research," said Stanley C. Erck, President and Chief Executive Officer. "We are satisfied with the levels of safety and tolerance demonstrated by our London trial. These results, though early, indicate that PRO 2000 may prove to be an important tool in the fight against HIV and other STDs."
Results of the Study
The double-blind, placebo-controlled study was conducted at St. Mary's Hospital in London under the supervision of Dr. Valerie Kitchen and Professor Jonathan Weber. Thirty-six healthy female volunteers applied either PRO 2000 Gel at one of two concentrations or a placebo gel intravaginally once a day for up to two weeks while refraining from sexual intercourse. The study was jointly funded by Procept and the British Medical Research Council (MRC) which granted over $1 million for safety studies of promising microbicides.
Unblinded data presented by Dr. Kitchen showed that gels containing up to 4.0% PRO 2000 (the highest concentration tested) were safe and well tolerated. Use of the product was not associated with genital irritation or microscopic inflammation, and did not affect normal vaginal pH or microflora. The results corroborate and extend the findings of the first Phase I study of PRO 2000 Gel, conducted at the Institute of Tropical Medicine in Antwerp, Belgium.
Procept, Inc., located in Cambridge, MA, is engaged in the development of novel drugs for the prevention of HIV and other infectious diseases through its lead product, PRO 2000 Gel.
Certain statements in this press release constitute "forward looking statements" which involve risks and uncertainties, including those arising under the Company*s business strategy; the success of the Company in financing efforts; the pursuit of collaborative arrangements for the research and development of product candidates, as well as seek joint development or licensing arrangements with pharmaceutical, diagnostic or instrumentation companies; the research or development of particular products, compounds or technologies; the uncertainty of the results of such development activities and related clinical trials or of required regulatory approvals; and the reliance on collaborative partners for development, regulatory or marketing activities.
Contact: Procept, Inc. Stanley C. Erck 617-491-1100 x3221 serck@procept.com or Robinson Lerer & Montgomery Mary Ann Dunnell 212-484-7797 mdunnell@rlmnet.com
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