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New PRO2000 HIV-Prevention Findings Important Milestone on Path Toward Development of Effective Vaginal Microbicide
Date:2/9/2009

Dr. Zeda Rosenberg, CEO of the International Partnership for Microbicides, issued the following statement on the results of the Phase II/IIb safety and effectiveness study of BufferGel and PRO2000 (0.5 percent concentration):

SILVER SPRING, Md., Feb. 9 /PRNewswire/ -- The Microbicide Trials Network, a worldwide collaborative group funded by the US National Institutes of Health, has released final results from its Phase II/IIb safety and effectiveness study of two microbicides, BufferGel and PRO2000 (0.5 percent concentration), both vaginal gels being tested to prevent HIV transmission to women during sex. BufferGel's primary action is to lower vaginal pH while PRO2000 is a large charged polymer designed to interfere with HIV's interactions with its target cells.

Results from the four-year trial (HPTN 035), conducted in Malawi, South Africa, the United States, Zambia and Zimbabwe, show that both products are safe as tested. Quite importantly, while BufferGel unfortunately did not show a protective effect against HIV, the trial indicated that PRO2000 was at least 30% more effective than any other arm in the study in preventing HIV. Neither BufferGel nor PRO2000 showed protection against any other sexually transmitted infection.

After disappointing results from several previous microbicide trials, these findings will be heartening to every woman who has ever felt powerless in the face of HIV. These findings are also an important milestone because they confirm the fundamental premise of vaginal microbicide science: that a woman can use a product topically and stop HIV infection.

This trial was not designed to generate definitive data on this product at this efficacy level. While the 30% effect within this trial is not statistically significant, the data is highly supportive. Additionally, the protective effect of PRO2000 is corroborated by analysis of various subgroups of women within the stu
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SOURCE The International Partnership for Microbicides
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