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BIOGEN RECOMBINANT SOLUBLE CD4 PHASE 1 STUDY

Executive Summary

BIOGEN RECOMBINANT SOLUBLE CD4 PHASE 1 STUDY in 25 ARC/AIDS patients began Oct. 12, the Cambridge-based biotech company announced in a same day press release. Safety studies for Receptin, the Biogen brand of CD4, are being conducted at two centers: Massachusetts General Hospital and Cedars-Sinai Medical Center in Los Angeles, both designated NIAID AIDS Clinical Trials Units. Robert Schooley, MD, at Massachusetts General and David Ho, MD, at Cedars-Sinai Medical Center are the clinical investigators for the study. Biogen's Receptin is the second recombinant CD4 product to be tested in human clinical trials. Gentech began Phase I studies of CD4 Aug. 10 ("The Pink Sheet" Aug. 15, p. 14). Biogen had been predicting that it would begin clinical trials by the end of this year but apparently jump-started ahead of schedule. Although Genentech was first to take CD4 to clinicals, Biogen claims that its scientists, working with Massachusetts General researchers, "were first to demonstrate in test tube experiments that Receptin blocked both direct infection of T-helper cells by HIV and cell-to-cell transmission of the virus," the release says. Discussing pre-clinical CD4 studies in Rhesus monkeys afflicted with Simian Immunodeficiency Virus (SIV), the Biogen release states, "Receptin has provided positive preliminary data . . . in this animal model, thought by researchers to closely mimic the interaction of HIV with human T-helper cells." Genentech studies are projected to run up to six months. Biogen has not released an expected date of completion for the clinical trials. Other companies developing CD4 products include SmithKline, which plans human testing by early next year, and California-based Genelabs, still preclinical operations.

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