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HIV microbicide

This article was originally published in The Tan Sheet

Executive Summary

The UK's Microbicide Development Program is conducting a Phase III clinical trial of PRO 2000, the topical, vaginal microbicide for HIV prevention developed by Indevus, the Lexington, Mass.-based company announces Oct. 25. The international double-blind, placebo-controlled trial will involve approximately 10,000 women and span three to four years. "We believe upon successful completion of the trials, we would be in position to file marketing applications with regulatory authorities, including a new drug application" with FDA, CEO Glenn Cooper announces, adding that the firm has also "begun discussions with potential public and private sector partners for the commercialization and distribution of PRO 2000." The trial is being sponsored by the U.K's Medical Research Council. An NIH-sponsored trial of the microbicide was announced in February (1"The Tan Sheet" Feb. 14, 2005, In Brief)...

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