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Today's news alerts include: VIA Pharmaceuticals Meets With FDA to Discuss Next Steps For VIA-2291 and Phase 3 Outcome Trial in Cardiovascular Disease
Safety and Biologic Activity Data Reviewed in End of Phase 2a Meeting
SAN FRANCISCO, June 11, 2009 -- VIA Pharmaceuticals, Inc. (Nasdaq: VIAP), a biotechnology company focused on the development of compounds for the treatment of cardiovascular and metabolic disease, announced today that an end of Phase 2a meeting for the Company's lead drug, VIA-2291 (atreleuton), was recently held with the U.S. Food and Drug Administration (FDA). The Company reviewed safety and biologic activity data from the VIA-2291 Phase 2 CEA and ACS trials with the FDA and received guidance including suggestions from the Agency on the Company's Phase 3 trial design.
VIA-2291 is a selective and reversible inhibitor of 5 Lipoxygenase, a key enzyme in the biosynthesis of leukotrienes, which are important mediators of the inflammation believed to be involved in the development and progression of atherosclerosis. The Company's Phase 3 cardiovascular outcome study will assess the effect of VIA-2291 in preventing cardiovascular events such as heart attack, stroke and cardiovascular mortality in patients with recent heart attack and/or established atherosclerotic cardiovascular disease. Guidance from the FDA will be incorporated into the VIA-2291 registration and Phase 3 program, and the company intends to submit its proposed Phase 3 plan to FDA including a request for a Special Protocol Assessment. The Company is currently exploring strategic opportunities for launching this final phase of development.
"The current treatment approaches have reached their potential, and yet there still exists a significant unmet medical need in heart disease, particularly in patients at high risk for heart attacks, strokes and cardiovascular death," said Larry Cohen, President and Chief Executive Officer of VIA Pharmaceuticals, Inc. "VIA-2291 specifically targets the inflammation in atherosclerotic plaque that is thought to trigger major adverse cardiac events. Our positive Phase 2 data demonstrate VIA-2291's potent inhibition of leukotrienes, lowering of hsCRP, and the potential for plaque stabilization as demonstrated by reduction in carotid plaque inflammation and non-calcified coronary plaque volume. We believe this compound is now ready for testing in a broad outcome Phase 3 trial that may establish a link between inflammation and reduction of these major adverse cardiac events."
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.
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