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Novel anti-oxidant and anti-inflammatory agent shows effectiveness on key endpoints in trial

March 28, 2007

Heart attacks are caused by a build-up and instability of plaque in the coronary arteries, which is often a result of chronic inflammation of the blood vessel walls. A study presented today at the American College of Cardiology's 56th Annual Scientific Session assessed whether adding a novel agent with antioxidant and anti-inflammatory properties to optimal medical therapy would reduce coronary events and death among patients with heart disease. ACC.07 is the premier cardiovascular medical meeting, bringing together more than 30,000 cardiologists to further breakthroughs in cardiovascular medicine.

While the trial results did not demonstrate a difference with the use of succinobucol (AGI-1067) versus placebo on the primary endpoint of a composite of major adverse cardiovascular events, the study did achieve a number of other important predefined endpoints, including a reduction in the composite of "hard" atherosclerotic clinical endpoints, composed of cardiovascular death, myocardial infarction (heart attack) and stroke with a relative risk reduction of 19 % (p=0.028); as well as an improvement in several key diabetes parameters, including fewer patients developing diabetes with a relative risk reduction of 64 % (p<0.0001), and better glycemic control (reduction of HbA1c of 0.5% at twelve months, p<0.0001) in patients randomized to succinobucol.

2 - 2 - 2 ALPHA Trial

The trial was entitled "Effects of the Novel Anti-Oxidant and Anti-Inflammatory Agent Succinobucol (AGI-1067) on Clinical Events in Patients With a Recent Acute Coronary Syndrome: The Aggressive Reduction of Inflammation Stops Events (ARISE) Study." "We are pleased with the meaningful improvement of patient outcomes observed with AGI-1067 (succinobucol) in the ARISE trial, which should help to address the burden of cardiovascular risk that exists despite our effective contemporary treatments." said Jean-Claude Tardif, M.D., Director of Research, Professor of Medicine, Montreal Heart Institute.

"The highest bar in clinical research is to improve the prognosis of patients that are already receiving optimal care," said Marc A. Pfeffer, M.D., Ph.D., Professor of Medicine, Harvard Medical School; Senior Physician at Brigham and Women's Hospital. "Although the formal primary composite endpoint in ARISE was not met, we believe that the trial generated strong evidence that use of AGI-1067 will produce tangible clinical benefits for patients with coronary artery disease."

The double-blind, placebo-controlled international trial enrolled 6,144 high-risk cardiovascular patients with unstable angina (chest pain) or who had suffered a heart attack. Patients were randomized to receive 300 mg of succinobucol (a novel, first-in-class anti-antioxidant with anti-inflammatory properties) daily, or matching placebo. Both groups of patients were already well-treated with the standard of care medications as prescribed by their physicians, including aspirin, statins, beta-blockers, calcium channel blockers, and oral anti-platelet and anti-coagulant agents. These promising findings indicate that succinobucol may be an additional therapy to reduce atherosclerotic complications beyond currently used modifications of risk factors. Researchers followed the patients an average of 24 months to determine rates of cardiovascular death, resuscitated cardiac arrest, heart attack, stroke, use of coronary revascularization and hospitalization for unstable angina diagnosed with blocked coronary artery.

Dr. Jean-Claude Tardif will present the results of this study on Tuesday, March 27 at 9:35 a.m. in Hall A.

American College of Cardiology