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AASLD Presentations Support the Initiation of a Broad Phase II Program with VX-950, an Investigational Oral HCV Protease Inhibitor
AASLD Presentations Support the Initiation of a Broad Phase II Program with VX-950, an Investigational Oral HCV Protease Inhibitor.
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[{"type":"text","content":"\n\n\n\n\n Vertex Announces Filing of IND in Support of\n VX-950 Phase II Development in the U.S.\n\nSAN FRANCISCO, Nov. 11 /CNW/ -- Clinical data being\npresented this week while attending the 56th American Association for the\nStudy of Liver Diseases (AASLD) Annual Meeting confirm that VX-950, an\ninvestigational oral hepatitis C protease inhibitor developed by Vertex\nPharmaceuticals Incorporated (Nasdaq: VRTX), was well-tolerated and possessed\npotent antiviral activity in a 14-day study in patients with hepatitis C virus\n(HCV) infection. The rapid decline in plasma HCV-RNA levels observed in HCV\npatients taking VX-950, together with a viral kinetic analysis that projects\nthe potential duration of treatment required to achieve sustained virologic\nresponse (SVR), support the evaluation of VX-950 in a novel, three-month\ncombination treatment paradigm. Vertex also announced today that it has filed\nan investigational new drug application (IND) with the U.S. Food and Drug\nAdministration (FDA) to support Phase II clinical development of VX-950.\n\"The clinical data demonstrate a swift and dramatic decline in viral\nlevels with VX-950, and provide insight into VX-950's potential to transform\nfuture HCV treatment,\" said Joshua Boger, Ph.D., Chairman, President and Chief\nExecutive Officer of Vertex. \"Our clinical development effort is gaining\nmomentum, as indicated by our recent IND submission with the FDA to support\nthe planned initiation before year-end of the first clinical study in what we\nexpect will be a broad Phase II program.\"\n\nPhase Ib Study Clinical Results: Major Findings\nFive presentations taking place at the meeting provide a comprehensive\nanalysis of the Phase Ib study of VX-950 given as monotherapy. Results being\npresented at the conference are from a dose-ranging Phase Ib study of VX-950\ndosed in an oral suspension for 14 days in patients with chronic hepatitis C.\nDr. Henk Reesink, Principal Investigator for the study, will present the major\nfindings in an oral presentation at the Presidential Plenary Session and at a\npress conference on Monday, November 14. In the Phase Ib study, VX-950 in all\ndose groups exhibited substantial antiviral effects, with 26 of 28 patients\nreceiving any dose of VX-950 achieving more than a 3-log reduction in plasma\nHCV-RNA within two days. After 14 days, patient...