Procept's PRO 2000 Gel Found Safe And Well Tolerated In Second
Clinical Trial
Results of London Phase I Study Presented at Retrovirus Conference
CAMBRIDGE, Mass.--(BW HealthWire)--Feb. 2, 1998-- Procept, Inc. (Nasdaq:PRCT - news) today is presenting the
results of its second Phase I clinical trial of PRO 2000 Gel at the 5th Conference on Retroviruses and Opportunistic Infections
in Chicago. PRO 2000 Gel, the Company's lead drug candidate, is designed as a female controlled topical microbicide to be
used for the prevention of human immunodeficiency virus type 1 (HIV-1) infection and other sexually transmitted diseases
(STDs) such as herpes simplex virus type 2, a cause of genital lesions which are believed to be a portal for HIV entry.
''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. |
