Gilead Sciences Inc.'s small molecule nucleotide analog GS504,also known as HPMPC, has shown anti-viral activity againstcytomegalovirus (CMV) in Phase I/II clinical trials in AIDSpatients.W. Lawrence Drew, director of clinical microbiology andinfectious diseases at the HIV Clinical Research Center at theUniversity of California, San Francisco (UCSF), presented theresults of these ongoing trials at the National Institutes ofHealth-National Institute of Allergy and Infectious DiseasesCollaborative Antiviral Study Group meeting in Bethesda, Md.
Drew said that GS504 seems to have anti-CMV activity inpatients with active viral infection or at risk for developingCMV retinitis at dose levels "within the anticipated therapeuticrange," but cautioned that higher doses are toxic. As a result,Gilead (NASDAQ:GILD) of Foster City, Calif., said it has modifiedits trial protocols to include dose-refinement studies, afterwhich it will conduct controlled safety and efficacy studies ofGS504 in AIDS patients with active CMV retinitis."Substantial additional clinical testing will be required for GS504, including efficacy trials," the company said.
-- Jennifer Van Brunt Senior Editor
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