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AIDS Therapy

IND application filed for protease inhibitor GS 9005

Published in Drug Week, February 13th, 2004

Gilead Sciences, Inc., (GILD) has submitted an investigational new drug (IND) application to the U.S. Food and Drug Administration to evaluate GS 9005 (formerly known as GS 4338) as a potential new therapy for HIV.

Under this IND, Gilead plans to assess the oral bioavailability, pharmacokinetics, safety, and efficacy of GS 9005 in healthy volunteers and HIV- positive patients. GS 9005 is a novel HIV protease inhibitor (PI) discovered at Gilead. Based on data from preclinical and in vitro studies, GS 9005 has the potential to be dosed as a single pill once daily and may have a clinical resistance profile that is distinct from commercially available drugs in the PI...

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