Business
Vertex Pharmaceuticals Initiates the First of Two Major Phase II Studies of VX-950 in Treatment-Naive HCV Patients
Vertex Pharmaceuticals Initiates the First of Two Major Phase II Studies of VX-950 in Treatment-Naive HCV Patients.
About this update from Vortex Energy Corp.
[{"type":"text","content":"\n\n\n\n\n - PROVE 1 & PROVE 2 Studies Expected to Enroll 580 Patients -\n\nCAMBRIDGE, Mass., May 23 /CNW/ -- Vertex Pharmaceuticals\nIncorporated (Nasdaq: VRTX) today reported that it has initiated PROVE 1, a\nmajor Phase II study of VX-950, an investigational oral hepatitis C virus\n(HCV) protease inhibitor. In addition, the Company today announced it expects\nto initiate PROVE 2, a second major Phase II study in June. The studies will\nbe conducted in the United States and Europe as part of a global Phase II\ndevelopment program for VX-950. Together, the two studies are expected to\nevaluate sustained viral response (SVR) rates in 580 treatment-naive patients\ninfected with genotype 1 HCV.\nVertex's global Phase II development program in treatment-naive patients\nhas three objectives: to evaluate the optimal SVR rate that can be achieved\nwith VX-950 therapy in combination with the current standard of care, to\nevaluate the optimal treatment duration for VX-950, and to evaluate the role\nof ribavirin in VX-950-based therapy. In addition to these two major studies,\nVertex expects to begin additional clinical studies of VX-950 in the second\nhalf of the year, including a Phase IIb study in patients who failed prior\nstandard of care treatment. Vertex anticipates this Phase IIb study to enroll\napproximately 400 patients. By the end of the first quarter of 2007, Vertex\nexpects to have enrolled approximately 1,000 patients in clinical trials of\nVX-950.\n\"PROVE 1 is the largest clinical study to date of an HCV protease\ninhibitor in triple combination therapy in a treatment-naive patient\npopulation, and provides us with the first opportunity to assess the potential\nto enhance sustained virologic response rates with a shortened treatment\nduration with VX-950, along with peginterferon and ribavirin,\" said John\nMcHutchison, M.D., Duke University and Lead Investigator for the PROVE 1\nstudy. \"Throughout this Phase II study, we will further develop a clinical\nand safety database and increase our experience with VX-950 among clinicians\nand patients.\"\n\nVX-950 Program Update\n\nPROVE Studies\nThe two studies announced today are the initial studies in a program of\nthe \"Investigation of HCV Protease Inhibition for Viral Eradication\" (PROVE).\nThe PROVE 1 and PROVE 2 studies have been designed as major, complementary\ns...