Comprehensive Phase 2 Program Combines Histology, Biomarkers and Non-Invasive Imaging to Demonstrate Mechanism of Action and Positive Impact on Vascular Inflammation
SAN FRANCISCO, May 14 /PRNewswire-FirstCall/ -- VIA Pharmaceuticals, Inc. , 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:
“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.”
About VIA Pharmaceuticals, Inc.
VIA Pharmaceuticals, Inc. is a biotechnology company focused on the development of compounds for the treatment of cardiovascular and metabolic disease. VIA’s lead candidate, VIA-2291, targets a significant unmet medical need: reducing inflammation in plaque, an underlying cause of atherosclerosis and its complications, including heart attack and stroke. In addition, VIA’s pipeline of drug candidates includes other compounds to address other underlying causes of cardiovascular disease: high cholesterol, diabetes and inflammation. For more information, visit: http://www.viapharmaceuticals.com.
Forward Looking Statements
This press release may contain “forward-looking” statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements relate to future events or to VIA’s future financial performance and involve known and unknown risks, uncertainties and other factors that may cause VIA’s actual results, levels of activity, performance or achievements to be materially different from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. In some cases, you can identify forward-looking statements by the use of words such as “may,” “could,” “expect,” “intend,” “plan,” “seek,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” “continue” or the negative of these terms or other comparable terminology. You should not place undue reliance on forward-looking statements since they involve known and unknown risks, uncertainties and other factors which are, in some cases, beyond VIA’s control and which could materially affect actual results, levels of activity, performance or achievements.
All forward-looking statements attributable to us or persons acting on our behalf are expressly qualified in their entirety by the cautionary statements set forth above. Forward-looking statements speak only as of the date they are made, and VIA undertakes no obligation to update publicly any of these statements in light of new information or future events.
CONTACT: James G. Stewart, Senior Vice President and Chief Financial
Officer of VIA Pharmaceuticals, Inc., +1-415-283-2204
Web site: http://www.viapharmaceuticals.com/