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VIA Pharmaceuticals Announces Positive Results of Phase 2 Studies of VIA-2291 in Patients With Serious Cardiovascular Disease
Date:11/9/2008

endpoints including reduction of high sensitivity C-reactive protein (hs-CRP) (p<0.01).

"VIA-2291 has the potential to be the first drug to specifically target one cardiovascular inflammatory pathway," said Dr. Jean-Claude Tardif, Director of the Montreal Heart Institute Research Centre, professor of medicine at the University of Montreal and principal investigator of the VIA- 2291 ACS trial. "These data support further clinical development of this drug, including larger outcome trials."

Cardiologists have several therapies that help reduce heart disease risk factors, but none that specifically targets inflammation, an underlying cause of atherosclerosis, which leads to major adverse cardiac events, including heart attack and stroke.

VIA-2291 is designed to be a selective and reversible inhibitor of 5-LO, a key enzyme in the biosynthesis of leukotrienes, that are important mediators of inflammation believed to be involved in the development and progression of atherosclerosis.

ACS and CEA Study Designs

The ACS Phase 2 study of VIA-2291 was designed to establish optimal dosing and safety data in 191 patients with ACS, who recently had a heart attack or unstable angina. Patients were treated once daily for 12 weeks with one of three doses of VIA-2291 or placebo. In order to further evaluate VIA-2291's effect over a longer timeframe, a sub-study of patients in the ACS trial continued for an additional 12 weeks of treatment at the same dose followed by a 64 slice multi-detector computed tomography (MDCT) scan following up on the baseline MDCT scan that all patients had received. The statistical outcomes for the ACS trial were validated by an independent academic statistics group at Montreal Heart Institute.

The CEA Phase 2 study evaluated VIA-2291's effect on atherosclerotic vascular inflammation in 50 patients scheduled for elective CEA. CEA is a surgical procedure to remove plaque from the carotid artery to increase blood flow
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SOURCE VIA Pharmaceuticals, Inc.
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