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Vertex Reports Investigational p38 MAP Kinase Inhibitor, VX-702, Meets Primary Objectives in Phase II Clinical Study in Rheumatoid Arthritis
Vertex Reports Investigational p38 MAP Kinase Inhibitor, VX-702, Meets Primary Objectives in Phase II Clinical Study in Rheumatoid Arthritis.
About this update from Vortex Energy Corp.
[{"type":"text","content":"\n\n\n\n\n -Vertex to Advance Clinical Program; Company Expects to Initiate Combination\n Study of VX-702 and Methotrexate by Mid-2006-\n\nCAMBRIDGE, Mass., March 8 /CNW/ -- Vertex Pharmaceuticals\nIncorporated (Nasdaq: VRTX) today announced that its investigational p38 MAP\nkinase inhibitor, VX-702, has met its primary objectives in a 12-week Phase II\nclinical study involving 315 patients. A preliminary analysis indicates that\nVX-702 was well-tolerated through 12 weeks of dosing, and demonstrated\nstatistically significant clinical effects on signs and symptoms of rheumatoid\narthritis (RA), as determined by ACR20 criteria, as well as several other\nwidely used clinical measures. The Company continues to conduct a full\nanalysis of safety, pharmacokinetics and efficacy data from the study. Vertex\nanticipates that results from the study will be presented at a medical\nconference later in 2006. The preliminary results from this study support\nVertex's plans to advance its clinical program and to initiate by mid-2006\nclinical studies of VX-702 in combination with methotrexate, a commonly used\ntherapy for RA. VX-702, dosed as one tablet, once a day, is one of the lead\nagents in a new class of investigational oral anti-cytokine therapies.\n\"Demonstration of clear effects on the signs and symptoms of RA, in\nconjunction with good tolerability with three months of treatment, represents\na major achievement for the VX-702 clinical program,\" commented John Alam,\nM.D., Executive Vice President, Medicines Development and Chief Medical\nOfficer at Vertex. \"The preliminary data announced today provide strong\nsupport for our plans to move forward in clinical development and evaluate\nVX-702 in combination with methotrexate in RA patients.\"\n\nVeRA: Clinical Study Design and Results\nThe VeRA study is a randomized, double-blind, 12-week, Phase II clinical\nstudy that enrolled 315 patients with moderate to severe RA. A total of 278\npatients completed 12 weeks of treatment. The study was conducted at more\nthan 40 centers in Eastern and Central Europe. Patients received either 5 mg\nor 10 mg VX-702 once daily, or placebo. In addition, patients could receive\ncertain disease-modifying anti-rheumatic drugs (DMARDs), but could not receive\nmethotrexate or anti-TNF therapies. At the end of 12 weeks, patients\ncompleted dosing with VX-7...