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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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NIH microbicide trial

The National Institute of Allergy & Infectious Diseases will fund a trial evaluating the safety and efficacy of Indevus Pharmaceuticals' topical microbicide PRO 2000, the firm announces Feb. 11. The study is expected to include 3,220 women recruited from five African countries - Malawi, South Africa, Tanzania, Zambia and Zimbabwe - and has an expected duration of 30 months. Participants will be placed into four equally sized groups and receive either PRO 2000, a second microbicide, a placebo gel or no gel. All participants also will receive condoms and prevention counseling during visits to the participating clinics. Study authors will "evaluate the effectiveness of the candidate microbicides in preventing HIV and other sexually transmitted infections, including gonorrhea, herpes and chlamydia," Indevus says, noting PRO 2000 is still in development. Panelists at an FDA Antiviral Drugs Advisory Committee meeting recommended a three-armed trial to study microbicides' net benefit (1"The Tan Sheet" Aug. 25, 2003, p. 7)...

Health And Wellness Trademark Review 22 September, 2020

Trademarks are registered and published for opposition with the US Patent and Trademark Office and are published weekly in the agency's Official Gazette.





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