Tuesday October 21 7:17 AM EDT
Company Press Release
Procept Completes Phase I Clinical Program for PRO 2000 Gel
CAMBRIDGE, Mass.--(BW HealthWire)--Oct. 21, 1997--
Antiviral gel well tolerated in Antwerp and London clinical trials
Procept Inc. (NASDAQ:PRCT - news) today announced the completion of its second Phase I safety trial in London, United
Kingdom with the company's lead drug candidate, PRO 2000 Gel. The product is designed to be used for the prevention of
human immunodeficiency virus type 1 (HIV-1) infection and other sexually transmitted diseases (STDs). Initial review of the
Phase I data indicates PRO 2000 Gel was well tolerated in healthy women.
The double-blind study, conducted at St. Mary's Hospital in London, involved 36 healthy female volunteers who
administered either PRO 2000 Gel or a placebo gel intravaginally for up to two weeks. No serious adverse events were
reported. A detailed analysis of the data is underway.
In June, Procept announced the completion of its first Phase I clinical trial of PRO 2000 Gel at the Institute of Tropical
Medicine in Antwerp, Belgium. On October 22, Dr. Lut Van Damme, one of the principal investigators, will present
unblinded data from the Antwerp trial at the International Congress of Sexually Transmitted Diseases in Seville, Spain.
Results from this study also indicate that PRO 2000 Gel is safe and well tolerated in healthy women.
''The successful completion of the Phase I clinical program allows us to focus on the design and implementation of Phase II
safety trials involving sexually active couples,'' said Stanley C. Erck, president and CEO. ''The safety and tolerance data
gathered in these studies should enable us to move quickly into Phase II/III trials in collaboration with world health agencies.''
Procept Inc. is engaged in the research and development of small molecule therapeutics for the prevention and treatment of
chronic and life-threatening immune system disorders. Procept is developing therapeutics for the treatment of autoimmune
diseases, organ transplant rejection and infectious diseases, such as AIDS and tuberculosis. Founded in 1985 and traded on
the Nasdaq National Market System under the symbol PRCT, Procept is located in Cambridge, Mass. |
