Procept's PRO 2000 Gel Selected to Enter
Government-Supported Clinical Trial
U.S. Food and Drug Administration Allows Study to Proceed Following IND Review
CAMBRIDGE, Mass.--(BW HealthWire)--Nov. 2, 1998--Procept, Inc. (Nasdaq:PRCT - news) today announced that its
lead product candidate, PRO 2000 Gel, was selected for safety testing in a human clinical trial supported by the National
Institute of Allergy and Infectious Diseases (NIAID), a unit of the National Institutes of Health (NIH). The United States Food
and Drug Administration (FDA) permitted the trial to proceed following review of an Investigational New Drug (IND)
application filed by Procept. The study, which will involve women in the United States and South Africa, is scheduled to begin
in early 1999.
PRO 2000 Gel is being developed as a topical microbicide for the prevention of sexually transmitted diseases (STDs), including
AIDS. It is designed to be applied vaginally before sexual intercourse. In laboratory studies, PRO 2000 Gel was shown to be
active against the human immunodeficiency virus (HIV, the cause of AIDS) as well as herpes simplex virus type 2 (HSV-2) and
Chlamydia trachomatis, two other common STD pathogens. Furthermore, intravaginally applied PRO 2000 Gel was shown to
prevent vaginal HSV-2 infection in mice. Two human Phase I clinical trials, conducted last year in Europe, found that daily
doses of PRO 2000 Gel were safe and well tolerated in healthy, sexually abstinent women. One of these studies was supported
by the British Medical Research Council (MRC).
The NIAID-supported clinical trial is designed to evaluate the safety and acceptability of PRO 2000 Gel in healthy, sexually
active women, and in HIV-infected women in the United States and South Africa. The trial will be conducted by the HIV
Network for Prevention Trials (HIVNET), an organization established by NIAID in 1993 to evaluate the safety and
effectiveness of different approaches to AIDS prevention, including vaccines, behavioral interventions, and topical microbicides.
HIVNET currently includes eleven domestic and eleven international field sites, as well as supporting infrastructure.
''We are excited that the NIH is supporting the continued clinical development of PRO 2000 Gel'' said John Dee, President
and Chief Executive Officer of Procept. ''The upcoming study represents the second major step on the clinical path leading to
product approval. We believe that Procept is well positioned to make a timely contribution to the urgent demand for new
methods to prevent HIV infection and other STDs. As a recent article in the respected trade publication Scrip noted, PRO
2000 Gel is 'the most advanced [new] microbicide in commercial development.'''
Large Potential Market Seen for Topical Microbicides
A recent study commissioned by the European Union found that a large potential market exists for vaginal microbicides capable
of preventing HIV infection and other STDs. For example, the potential market in Brazil alone was estimated to approach $1
billion per year. The results of the survey, presented at the 12th World AIDS Conference in Geneva last July, showed that
many women in both developed and developing countries would find a female-controlled prevention product ''very useful'', and
would be willing to spend significantly more than the price of a condom for it. Interestingly, most women favored a ''dual-use''
product that had both antimicrobial and contraceptive properties. PRO 2000 Gel has also been shown to be contraceptive in
rabbits.
Procept, Inc., located in Cambridge, MA, is a biopharmaceutical company currently engaged in the development of novel
drugs with a focus on anti-infectives and immunosuppressants. Its lead product, PRO 2000 Gel, is being developed as a
female-controlled topical microbicide for the prevention of HIV infection and certain other sexually transmitted diseases.
Procept also plans to out-license its early-stage immunosuppressive research and to in-license high-potential drug development
compounds. |
