INDEVUS ANNOUNCES INITIATION OF PRO 2000 TRIAL

Indevus Pharmaceuticals has announced the initiation of a large, international Phase III clinical trial of PRO 2000, the company's topical vaginal microbicide in development for the prevention of sexually transmitted infections, including HIV, herpes, chlamydia and gonorrhea.

The trial has opened for enrollment at clinics in Johannesburg, South Africa, and the Masaka district of Uganda, and is expected to expand to additional sites in South Africa, Tanzania and Zambia. Approximately 10,000 women will be enrolled in the trial, which is expected to last approximately three to four years and include interim analyses of safety and efficacy data conducted by an independent data safety monitoring committee.

Each woman enrolled in this double-blind, placebo-controlled trial will be assigned at random to receive one of two PRO 2000 strengths or a placebo. The women will be asked to apply the study product prior to sexual intercourse. In addition, all participants will receive condoms and risk-reduction counseling. Researchers will evaluate the effectiveness of PRO 2000 relative to placebo in preventing HIV and other sexually transmitted infections, including gonorrhea, herpes and chlamydia.