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New Data Suggest Vertex's Oral Hepatitis C Virus Protease Inhibitor VX-950 May Reduce Liver Injury; VX-950 Clinical Milestones on Track
New Data Suggest Vertex's Oral Hepatitis C Virus Protease Inhibitor VX-950 May Reduce Liver Injury; VX-950 Clinical Milestones on Track.
About this update from Vortex Energy Corp.
[{"type":"text","content":"\n\n\n\n\nMONTREAL, Oct. 3 /CNW/ -- New data show that patients\nwith genotype 1 hepatitis C virus (HCV) infection treated with VX-950, an\ninvestigational oral HCV protease inhibitor being developed by Vertex\nPharmaceuticals Incorporated (Nasdaq: VRTX), rapidly achieved substantial\nreductions in alanine aminotransferase (ALT) levels after 14 days of\ntreatment. The findings were presented today by researchers at the 12th\nInternational Symposium on Hepatitis C and Related Viruses (HCV 2005) in\nMontreal, Canada. Vertex also provided an update on clinical development of\nVX-950, which is one of the most advanced of a new class of medicines in\ndevelopment for the treatment of chronic hepatitis C infection.\nData from a 14-day clinical study demonstrated that treatment with any one\nof three doses of VX-950 resulted in median serum ALT declines of 25-32 U/L in\nall dose groups. In the placebo group, a median 8 U/L increase was observed.\nPrior to treatment with VX-950, serum ALT levels were elevated in\napproximately 70 percent of patients in the study. In the VX-950 dose groups,\n83 percent (15 of 18) of patients with elevated ALT levels at baseline (prior\nto treatment) had achieved normalization of ALT levels at day 14, compared to\n0 percent (0 of 6) in the placebo group. Elevated ALT levels are common in\nHCV patients and are considered to be a marker of liver injury due to HCV\ninfection. Mean levels of serum neopterin also were observed to decrease with\nVX-950 treatment in the study. Decreased neopterin levels may be a further\nsignal of a reduction in inflammation associated with HCV infection.(1)\nA study of viral isolates from patients at baseline in a 14-day clinical\nstudy, also presented at the conference, found heterogeneity among viral\nsequences in the HCV protease domain. In vitro analysis indicated that all\nbaseline viral isolates were sensitive to VX-950.(2)\n\"To date, data from early clinical studies have suggested that VX-950 is\nwell-tolerated and can rapidly reduce HCV viral levels in patients over a\nshort treatment period,\" said John Alam, M.D., Senior Vice President of Drug\nEvaluation and Approval at Vertex. \"In addition, we now have evidence that\ntreatment with VX-950 appeared to lead to a dramatic decline in markers of\nliver injury associated with viral infection.\"\n\nClinical Update\nVertex...