To all:
Here is the news came out late afternoon.
Tuesday January 21 3:50 PM EDT
Phase I clinical trial for topical microbicide initiated in London
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Jan. 21, 1997--
Procept and British Medical Research Council
begin safety evlauation of PRO 2000 to prevent HIV infection
Procept Inc announced today that it has initiated a Phase I clinical trial of its PRO 2000 topical microbicide in
London, England. The intravaginally applied gel is intended to protect women from infection by HIV and other
sexually transmitted diseases.
The Phase I trial is designed to assess the safety of the gel in healthy volunteers. Approximately 36 women will
be enrolled in the study, which will be conducted at St. Mary's Hospital in London. Professor Jonathan Weber
and Dr. Valerie Kitchen will serve as principal investigators.
Procept and its collaborators have shown in extensive laboratory studies that the gel's active ingredient, PRO
2000, is able to block infection by a wide range of HIV strains. Its activity against other sexually transmitted
diseases is being evaluated.
"Development of a drug to prevent sexual transmission of HIV has been declared a national priority by the U.S.
government," said Stanley C. Erck, president and Chief Executive Officer of Procept. "Procept's PRO 2000
antiviral compound appears to be well suited to address this need." There is currently no proven
female-controlled method for preventing HIV infection.
As announced previously, the Phase I study is jointly funded with the British Medical Research Council (MRC)
through a research grant of over $1 million for safety studies of promising microbicides. Under the direction of
Dr. Alan Stone, the MRC is building an infrastructure to support the development of effective topical
microbicides. This includes, as well as safety studies, the design of Phase II and Phase III clinical trials, the
identification of qualified clinical trial sites, and the establishment of in vitro measures of anti-HIV efficacy.
The Medical Research Council aims to improve health by promoting research into all areas of medical and
related science. Established in 1913, the MRC is funded mainly by the British government, but is independent
in its choice of which research to support.
In December, Procept announced the initiation of a Phase I study at the Institute of Tropical Medicine in
Antwerp, Belgium of its PRO 2000 topical microbicide. This study is under the direction of Professor Marie
Laga and Dr. Lut van Damme. The company believes that the two studies will provide valuable information on
the safety and tolerability of its PRO 2000 gel.
Procept Inc., headquartered in Cambridge, Mass., is engaged in the discovery and development of small
molecule therapeutics for the prevention and treatment of chronic and life-threatening immune system disorders.
The company's research is based upon its understanding of critical cell receptors responsible for modulating
immune responses. Procept is developing therapeutics for the treatment of arthritis, diabetes, organ transplant
rejection and infectious diseases, including AIDS and tuberculosis. Procept was founded in 1985 and is traded
on the Nasdaq National Market System under the symbol PRCT.
CONTACT: Procept, Inc.
Stanley C. Erck
617/491-1100
or
INFOCUS, Inc.
Karen M. Goldman (media)
609/683-9055 |
