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CDC HIV/AIDS/Viral Hepatitis/STD/TB Prevention News Update
Burroughs Wellcome Co. Begins U.S. Clinical Trial Program with

March 1, 1995
PR Newswire (02/28/95)

On Tuesday, Vertex Pharmaceuticals Inc. and Burroughs Wellcome Co. announced the commencement of a Phase I clinical trial for VX-478 in the United States. The trial is a dose escalation trial designed to test the tolerability, pharmacokinetics, and oral bioavailability of VX-478, an orally administered protease inhibitor for the treatment of HIV infection and AIDS that was designed by Vertex. The study is the first in an international clinical development program for VX-478 being undertaken by Burroughs Wellcome, Kissei Pharmaceutical Co., and Vertex. Burroughs Wellcome and Kissei will use the results of the trial to develop trials to determine the safety and anti-HIV efficacy of VX-478 alone and in combination with reverse transcriptase inhibitors. "The Burroughs Wellcome- sponsored clinical program and the Kissei studies planned for Japan are part of an effort that is both extensive and designed to generate data rapidly on VX-478," said Dr. Joshua Boger, President and CEO of Vertex. "We and our partners believe that the pharmaceutical attributes of VX-478 make it a very promising drug candidate for the treatment of AIDS and HIV infection."