Data complement anti-STD activity of PRO 2000 gel. Contraceptives

Procept, Cambridge, Massachusetts, announced preclinical results demonstrating the contraceptive efficacy of its PRO 2000 topical microbicide gel. In a program of late-breaking discoveries presented at the National Conference on Women and HIV, held in Pasadena, California, Procept scientists described the results of studies recently conducted with PRO 2000. The in vitro results showed that PRO 2000 was contraceptive when rabbits were dosed intravaginally with a gel containing a 4% concentration of PRO 2000. At a concentration about 10 times lower, PRO 2000 did not appear to affect the rabbit pregnancy rate. Results of preclinical tests have indicated that both concentrations prevent HIV infection, suggesting that contraceptive and noncontraceptive formulations of this drug may be developed. "The potential of this compound as an advancement in the area of women's health is significant," said Stanley C. Erck, Procept. "We believe that the contraceptive properties demonstrated by PRO 2000 Gel will complement the anti-HIV/STD activity we will be evaluating in clinical trials." "More than 70% of all HIV infections worldwide follow heterosexual intercourse. A major problem confounding efforts to prevent AIDS in women has been the lack of effective, female-controlled barrier methods. PRO 2000 Gel has been identified as a topical microbicide well suited for use by women to prevent HIV infection. In laboratory studies, PRO 2000 blocked infection by a wide variety of HIV strains and also was active against herpes simplex virus." Clinical studies currently are underway to assess the safety of PRO 2000 Gel in healthy female volunteers. Assuming the results of these studies are positive, additional studies will be conducted to demonstrate safety and efficacy in populations at high risk for HIV infection.