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Phase 3 Trial of AGI-1067 Reaches Patient Enrollment Target
ATLANTA, Nov. 22 /PRNewswire-FirstCall/ -- AtheroGenics, Inc. , a pharmaceutical company focused on the treatment of chronic inflammatory diseases, today announced that the original patient enrollment target of 4,000 has been reached for ARISE, a pivotal Phase III clinical trial of AGI-1067 for the treatment of atherosclerosis. As indicated in October, the Company plans to continue enrollment so as to accelerate the accumulation of patient years of exposure on the drug.
"We are pleased to have reached this important milestone in the ARISE trial," commented AtheroGenics' Senior Vice President of Clinical Development and Regulatory Affairs and Chief Medical Officer, Rob Scott, M.D. "The high level of interest and enthusiasm among the investigational sites, physicians and patients participating in the trial has been gratifying. With their help, we are one step closer to our goal of developing an oral therapy that directly targets the underlying inflammation of atherosclerosis, as opposed to current cardiovascular therapies that only address risk factors."
ARISE is a multi-national, double-blind, placebo-controlled study to evaluate the effect of AGI-1067 on important clinical outcome measures including death due to cardiovascular disease, myocardial infarction, stroke, coronary-revascularization and unstable angina in patients who have coronary artery disease. The Phase III study is designed to assess the incremental benefits of AGI-1067 over current "standard of care" therapies in this patient population. Eligible patients are being randomized to receive oral AGI-1067 300mg or placebo, once daily, in addition to receiving other appropriate heart disease medications, which may include statins and other cholesterol-lowering therapies, high blood pressure medications and anti-clotting agents.
"The ARISE study will provide us with important information as to whether an agent with anti-inflammatory properties can provide clinically significant reduction of mortality and morbidity when used in conjunction with the current standard of care therapies in patients with coronary artery disease," stated Marc A. Pfeffer, M.D., Ph.D., Interim Chairman, Department of Medicine, Brigham and Women's Hospital and Co-Chair, ARISE Steering Committee. "We know that current therapies provide a risk reduction of approximately 35%, however, this patient population is in need of additional risk reduction from novel therapeutic agents."
"While statins and other cholesterol-lowering therapies have proven to be beneficial in slowing the progression of heart disease, the anti-inflammatory properties of AGI-1067 may become a powerful complement to statin use," said Jean-Claude Tardif, M.D., Director of the Research Center and Associate Professor of Medicine at the Montreal Heart Institute and Co-Chair, ARISE Steering Committee.
AtheroGenics has a written confirmation from the U.S. Food and Drug Administration (FDA) on the protocol for ARISE, which, if successful, would support a New Drug Application (NDA) for AGI-1067 with an indication for secondary prevention in patients with coronary heart disease. Secondary prevention for atherosclerotic cardiovascular disease is treatment that improves patient survival, reduces recurrent events, such as heart attack and stroke, reduces the need for interventional procedures, and improves the quality of life for these patients. This confirmation was attained under the FDA's special protocol assessment (SPA) process.
Atherosclerosis is a common and progressive disease of the arteries that results from inflammation and the dangerous accumulation of fat-laden deposits, or plaques, in the arteries. Inflammation can also cause certain plaques to rupture. Blood clots tend to form over ruptured plaques and can then block blood flow through the arteries, leading to such atherosclerotic complications as heart attack and stroke. There are currently no medications available for physicians to treat directly the underlying chronic inflammation of atherosclerosis.
More than 13 million adults in the United States have a current diagnosis of coronary heart disease. Each year in the United States, one-third of the 1.5 million individuals who experience myocardial infarctions (heart attacks) will die.