Business
Vertex Successfully Completes Key Studies with VX-950 to Prepare for Next Steps in Clinical Program
Vertex Successfully Completes Key Studies with VX-950 to Prepare for Next Steps in Clinical Program.
About this update from Vortex Energy Corp.
[{"type":"text","content":"\n\n\n\n\n-- Plasma HCV RNA levels are less than 10 IU/mL in 12 of 12 patients after 28\n days of dosing with VX-950/peg-IFN/RBV in Phase II study --\n\nCAMBRIDGE, Mass., Feb. 7 /CNW/ -- Vertex Pharmaceuticals\nIncorporated (Nasdaq: VRTX) today announced that it has completed dosing with\nVX-950 in a Phase II, 28-day clinical study in hepatitis C virus (HCV)\ninfected patients. In addition, the Company announced that it has completed\nthree-month animal toxicology studies that will support clinical studies of\nVX-950 of up to three months duration. Initiation of additional Phase II\nclinical studies in the U.S. in patients with HCV is planned following\nrequired Food and Drug Administration (FDA) review of these latest non-\nclinical and clinical results, and FDA review of a proposed clinical study\nprotocol. This information will be submitted to the FDA within the first\nquarter of 2006.\n\nClinical Study Design and Results\nThe 28-day, Phase II clinical study enrolled 12 treatment-naive patients\nwith genotype 1 HCV. Patients received VX-950 in a tablet formulation at a\ndose of 750 mg every eight hours (q8h) for 28 days in combination with\nstandard doses of pegylated interferon alfa-2a (Pegasys(R); peg-IFN) and\nribavirin (Copegus(R); RBV). At the end of 28 days, patients completed dosing\nwith VX-950 and per study protocol were required to continue treatment with\npeg-IFN and RBV. This 28-day, Phase II study was not designed to evaluate\nsustained viral responses (SVR) in patients receiving VX-950.\nThere were no treatment discontinuations and no serious adverse events\nreported. A detailed safety analysis is ongoing.\nFor patients entering the study, the distribution of baseline plasma HCV\nRNA values was typical for a treatment-naive patient population. At the end\nof week 1 (day 8 of VX-950 dosing), plasma HCV RNA was below the limit of\nquantitation (30 IU/mL; Roche Taqman(R) assay) in six of the 12 patients; and\nundetectable (less than 10 IU/mL; Roche Taqman(R) assay) in two of 12\npatients. Preliminary HCV RNA results in patients for weeks 2-4 are as\nfollows:\n\n At the end of week 2, plasma HCV RNA was below the limit of quantitation\n (30 IU/mL) in 11 of the 12 patients; and undetectable (less than 10\n IU/mL) in three of 12 patients.\n At the end of week 3, plasma HCV RNA was below the limit of quantitation\n (30...