Posted on Wednesday, Jan. 23, 2008
Vertex Pharmaceuticals to Begin Phase 3 Development of Telaprevir, Investigational Hepatitis C Protease Inhibitor
Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that it will begin Phase 3 evaluation of telaprevir, Vertex's lead investigational hepatitis C protease inhibitor. The primary focus will be a global, 3-arm pivotal controlled trial that will evaluate two 24-week telaprevir-based regimens in approximately 1050 treatment-naive genotype 1 HCV patients. In this study, rapid viral response (RVR) criteria will be used to determine which telaprevir patients can stop all treatment at 24 weeks. A second study of approximately 400-500 HCV patients is planned to evaluate a 48-week telaprevir-based regimen, to confirm the results from Phase 2 studies and provide additional evidence that supports the 24-week regimen that is being evaluated in the primary Phase 3 trial. The Company expects that both studies will run concurrently and that the first trial will begin enrolling patients in March 2008.
"Data presented in late 2007 from two large Phase 2b studies suggest that telaprevir, dosed in combination with pegylated interferon and ribavirin, may be able to meaningfully increase the proportion of treatment-naive genotype 1 HCV patients who achieve a sustained viral response, and also cut the current treatment duration in half, to 24 weeks," said John McHutchison, M.D., Principal Investigator for the primary telaprevir Phase 3 pivotal study and Associate Director of Duke Clinical Research Institute. "Telaprevir is the most advanced protease inhibitor in development for hepatitis C, and the initiation of Phase 3 clinical development for this investigational drug will begin the process of helping to further assess its potential efficacy and the safety in a larger number of patients."
Pivotal Trial to Evaluate 24-Week Telaprevir-Based Treatment Regimens
VRTX - Vertex Pharmaceuticals Inc.
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