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Indevus Pharmaceuticals Announces PRO 2000 Found to Show Promise in Large HIV Prevention Study
Date:2/9/2009

women who had been using a topical microbicide or oral antiretrovirals as an HIV preventive measure when they acquired HIV infection.

A second large trial testing the safety and effectiveness of the 0.5% dose of PRO 2000 is currently underway. This trial is being sponsored by the United Kingdom's Medical Research Council (MRC) and conducted by the Microbicides Development Programme (MDP), an international partnership of researchers established to develop microbicides for the prevention of HIV transmission. Study MDP 301 is a multi-national, randomized, double-blind, placebo-controlled Phase III trial designed to examine the safety and effectiveness of PRO 2000 in preventing HIV infection in women. As in the HPTN 035 trial, all participants receive free condoms, risk-reduction counseling, and treatment for sexually transmitted infections. Approximately 9,400 women have been enrolled at study sites in South Africa, Tanzania, Uganda, and Zambia. The trial is expected to be completed during the summer of 2009.

Should PRO 2000 be shown conclusively to be safe and effective, Indevus intends to seek worldwide marketing approvals, and plans to work with government agencies and other organizations to help ensure affordable access to the product in resource-limited settings where the need is greatest.

According to statistics from UNAIDS and the U.S. Centers for Disease Control and Prevention, nearly half of the 33 million people living with HIV/AIDS worldwide are women. Most HIV infections in women are due to heterosexual intercourse. Moreover, women are twice as likely as their male partners to acquire HIV during sex, due in part to biological factors that make women more vulnerable. Although correct and consistent use of male condoms has been shown to prevent HIV infection, women often cannot negotiate condom use with their male partners. A safe and effective vaginal microbicide could offer a readily available app
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SOURCE Indevus Pharmaceuticals, Inc.
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