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Vertex Pharmaceuticals Announces Start of Phase II Clinical Development for Investigational Oral Hepatitis C Virus Protease Inhibitor VX-950
Vertex Pharmaceuticals Announces Start of Phase II Clinical Development for Investigational Oral Hepatitis C Virus Protease Inhibitor VX-950.
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[{"type":"text","content":"\n\n\n\n\n - Investigational New Drug Application Activated in the U.S. -\n\nCAMBRIDGE, Mass., Dec. 5 /CNW/ -- Vertex Pharmaceuticals\nIncorporated (Nasdaq: VRTX) announced today the initiation of a Phase II\nclinical trial for VX-950, an investigational oral hepatitis C virus (HCV)\nprotease inhibitor for the treatment of HCV infection. The 28-day study will\nevaluate the safety, tolerability and pharmacodynamics of VX-950 when combined\nwith pegylated interferon and ribavirin. Pegylated interferon and ribavirin\nare two approved treatments for HCV infection. Twelve treatment-naive\nsubjects will be enrolled in the study at two centers in the United States.\nThis is the first clinical study of VX-950 to be initiated under an open\ninvestigational new drug (IND) application with the United States Food and\nDrug Administration, and marks the beginning of a broad Phase II clinical\ndevelopment program planned for VX-950 that will evaluate the compound in\nmultiple clinical studies in 2006, including a three-month study in more than\n200 treatment-naive patients.\n\"This first Phase II study for VX-950 will enable Vertex to evaluate the\nsafety, tolerability and pharmacodynamics of VX-950 over 28 days when combined\nwith pegylated interferon and ribavirin,\" said John Alam, M.D., Senior Vice\nPresident of Drug Evaluation and Approval at Vertex. \"This initial Phase II\ntrial is anticipated to support the evaluation of VX-950 in a key three-month\nPhase II study in more than 200 HCV patients that we expect to initiate in\nearly 2006.\"\n\nPhase II Development Plans\nThe objectives of the 28-day Phase II study announced today are to\nevaluate the safety, tolerability and pharmacodynamics of VX-950 dosed at\n750 mg every eight hours with standard doses of pegylated interferon and\nribavirin. Vertex expects to obtain 28-day results from this initial Phase II\nstudy in the first quarter of 2006. Following completion of 28 days of\ntreatment, patients will receive the standard of care. In early 2006, Vertex\nexpects to initiate a three-month Phase II clinical study in more than 200\ntreatment-naive subjects. A major objective of this three-month study, in\naddition to an evaluation of safety, will be to measure HCV RNA at the end of\ntreatment and post-treatment as a measure for sustained viral response,\npotentially enabling a decision ...