Vertex (VRTX) Reports Encouraging Data from Phase 2 PROVE 2 of INCIVEK; Begins Enrollment in Phase 2b
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Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced data from a retrospective subanalysis of the Phase 2 PROVE 2 study that showed that 100 percent (12/12) of patients with the IL28B CC genotype who were new to treatment achieved a viral cure (sustained viral response, or SVR) with a total of 12 weeks of treatment with INCIVEK™ (telaprevir) tablets, pegylated-interferon and ribavirin. These data support Vertex’s ongoing Phase 3b study that is evaluating a total treatment duration as short as 12 weeks in people with the IL28B CC genotype. Data from the PROVE 2 subanalysis and 13 other abstracts on INCIVEK and Vertex’s medicines in development for the treatment of hepatitis C will be presented at the 47th Annual Meeting of the European Association for the Study of the Liver (EASL) in Barcelona, Spain, April 18 to 22, 2012.
Vertex also announced today plans to open for enrollment a Phase 2b study to evaluate an all-oral (interferon-free) treatment regimen as short as 12 weeks in people with genotype 1 (1a and 1b) hepatitis C. The study is part of Vertex’s commitment to exploring multiple interferon-free combinations with its portfolio of four direct-acting antivirals that, in addition to INCIVEK, which was approved by the U.S. Food and Drug Administration (FDA) in May 2011, include a non-nucleoside polymerase inhibitor and two distinct nucleotide polymerase inhibitors. Vertex continues to evaluate ways to expand and improve treatment with ongoing studies of INCIVEK combination therapy. The company’s broad portfolio and development program support its goal of further shortening treatment time, improving convenience and tolerability and increasing viral cure rates for people with hepatitis C.
Vertex also announced today plans to open for enrollment a Phase 2b study to evaluate an all-oral (interferon-free) treatment regimen as short as 12 weeks in people with genotype 1 (1a and 1b) hepatitis C. The study is part of Vertex’s commitment to exploring multiple interferon-free combinations with its portfolio of four direct-acting antivirals that, in addition to INCIVEK, which was approved by the U.S. Food and Drug Administration (FDA) in May 2011, include a non-nucleoside polymerase inhibitor and two distinct nucleotide polymerase inhibitors. Vertex continues to evaluate ways to expand and improve treatment with ongoing studies of INCIVEK combination therapy. The company’s broad portfolio and development program support its goal of further shortening treatment time, improving convenience and tolerability and increasing viral cure rates for people with hepatitis C.
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