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FDA Grants Fast Track Designation to Vertex's Investigational Oral Hepatitis C Virus Protease Inhibitor VX-950
FDA Grants Fast Track Designation to Vertex's Investigational Oral Hepatitis C Virus Protease Inhibitor VX-950.
About this update from Vortex Energy Corp.
[{"type":"text","content":"\n\n\n\n\nCAMBRIDGE, Mass., Dec. 8 /CNW/ -- Vertex Pharmaceuticals\nIncorporated (Nasdaq: VRTX) today announced that the U.S. Food and Drug\nAdministration (FDA) has granted Fast Track designation to VX-950, an\ninvestigational oral hepatitis C virus (HCV) protease inhibitor for the\ntreatment of HCV infection. The FDA granted Fast Track designation to VX-950\nfor the following reasons:\n Chronic hepatitis C virus infection is a serious and life-threatening\n disease.\n VX-950 has the potential to shorten the duration of therapy compared to\n the standard of care, which may result in improved sustained virologic\n response rates and a more favorable adverse event profile.\nVertex is currently conducting a clinical development program to assess\nwhether VX-950 will address these unmet medical needs in HCV therapy.\nUnder the FDA Modernization Act of 1997, Fast Track designation indicates\nthat the FDA will facilitate the development and may expedite the review of a\ndrug if it is intended for the treatment of a serious or life-threatening\ncondition and demonstrates the potential to address an unmet medical need for\nsuch a condition.\n\nVX-950 Clinical Status\nEarlier in 2005, Vertex concluded a 14-day, Phase Ib study of VX-950 that\nshowed a rapid and dramatic reduction in HCV RNA in HCV patients when VX-950\nwas administered as a single agent. Overall in the Phase Ib study, adverse\nevents observed in patients receiving VX-950 that were considered possibly\nrelated to the drug were mild, and generally similar in frequency to events in\nthe placebo group. The most common adverse events reported in both placebo\nand VX-950 patients were headache, frequent urination and gastrointestinal\nsymptoms. Based on these encouraging Phase Ib clinical results, Vertex\nrecently initiated two additional clinical studies with VX-950. In October\n2005, Vertex initiated in Europe a 20-patient Phase Ib study of VX-950 dosed\nin combination with pegylated interferon. In December 2005, Vertex initiated\nin the United States the first Phase II study of VX-950, which will evaluate\nthe safety, tolerability and pharmacodynamics of VX-950 when dosed with\npegylated interferon and ribavirin. Vertex expects to obtain results from\nboth these Phase Ib and Phase II studies of VX-950 in early 2006. Vertex also\nexpects to initiate multiple additional Phase...