For Immediate Release
VIA Pharmaceuticals Announces Complete Enrollment in FDG-PET Phase 2 Study of VIA-2291 in Cardiovascular Patients
Comprehensive Phase 2 Program Combines Histology, Biomarkers and Non-Invasive Imaging to Demonstrate Mechanism of Action and Positive Impact on Vascular Inflammation
May 14, 2009
San Francisco, CA -- VIA Pharmaceuticals, Inc. (Nasdaq: VIAP), a biotechnology company focused on the development of compounds for the treatment of cardiovascular and metabolic disease, today announced that it has completed enrollment in a Phase 2 clinical trial of its lead drug, VIA-2291 in patients who have experienced an acute coronary syndrome event such as a heart attack or unstable angina. The randomized, double blind, placebo-controlled study examines the impact of VIA-2291 on plaque inflammation as measured by Positron Emission Tomography with fluorodeoxyglucose tracer (FDG-PET), as well as other standard biomarkers of inflammation, over 24 weeks following such an acute event. A total of 52 patients have been enrolled in the study, which is expected to report data in the second half of 2009.
VIA-2291 is designed to be a selective and reversible inhibitor of 5 Lipoxygenase, a key enzyme in the biosynthesis of leukotrienes, which are important mediators of inflammation believed to be involved in the development and progression of atherosclerosis. The FDG-PET study is the third Phase 2 clinical trial of VIA-2291 conducted by the Company in cardiovascular disease. In addition to being generally well-tolerated, earlier studies reported at the American Heart Association 2008 Scientific Sessions in November 2008, and the American Heart Association Arteriosclerosis, Thrombosis and Vascular Biology Annual Conference 2009 in May 2009, suggest multiple effects of the drug on inflammation, as measured through histology, biomarkers and advanced imaging. These include:
-- Significant, dose dependent, inhibition of Leukotriene B4 (LTB4) production,
-- A significant reduction from baseline as compared with placebo of high sensitivity C-reactive protein (hs-CRP),
-- A reduction in necrotic core thickness relative to plaque thickness as measured with histology, and
-- A significant reduction in plaque volume and a reduced number of new plaque lesions as measured by serial multidetector computed tomography (MDCT) scans.
"There is growing weight to the evidence supporting VIA-2291's effect on inflammation in atherosclerotic plaques," said Rebecca A. Taub, M.D., Sr. Vice President - Research & Development of VIA Pharmaceuticals. "No therapy currently exists to directly target inflammation, an underlying cause of atherosclerosis and major adverse cardiac events, such as heart attack and stroke. FDG-PET is a new and leading-edge imaging technology for cardiovascular patients, that we feel will provide yet another insight into VIA-2291's ability to target plaque inflammation in patients with serious cardiovascular disease. In addition, the FDG-PET study focuses on the target patient population that is relevant to our anticipated, larger outcome studies."
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