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LEXINGTON, Mass., Feb. 15 /PRNewswire-FirstCall/ -- Indevus Pharmaceuticals, Inc. (Nasdaq: IDEV) announced today that they have been advised by the United Kingdom's Medical Research Council (MRC) that after review of data from the Phase III clinical trial of PRO 2000, the Company's candidate vaginal microbicide for HIV prevention, the Independent Data Monitoring Committee (IDMC) has recommended that the low-dose arm (0.5%) continue to be tested for safety and effectiveness in the trial. The IDMC, a group of independent experts providing oversight to the MDP 301 trial, also recommended the high-dose arm (2.0%) be closed as there is no more than a small chance of the high dose showing protection against HIV infection compared to placebo gel. The trial is sponsored by the MRC and conducted by the Microbicides Development Programme (MDP), an international partnership of researchers established to develop microbicides for the prevention of HIV transmission. The 0.5% dose of PRO 2000 is also being tested for safety and effectiveness in Protocol HPTN 035 sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH).
"We are encouraged that the MRC has decided to continue testing the 0.5% dose of PRO 2000 at this advanced stage of the MDP 301 trial," stated Glenn L. Cooper, M.D., chairman and chief executive officer of Indevus. "Additionally, the NIAID trial, which has completed enrollment, continues to test the 0.5% dose of PRO 2000. We are hopeful that this dose will prove to be a safe and effective treatment for the prevention of the sexual transmission of HIV."
Dr. Cooper continued, "We are grateful for the generous government
support of the program, both in terms
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| SOURCE Indevus Pharmaceuticals, Inc. Copyright©2008 PR Newswire. All rights reserved |