Healthcare Industry News:  Acute Coronary Syndrome 

Biopharmaceuticals Cardiology

 News Release - April 13, 2007

First Patient Enrolled in Phase 2 'PLASMA' Trial With A-002 for Patients With Coronary Atherosclerosis

SAN MATEO, Calif., April 13 (HSMN NewsFeed) -- Anthera Pharmaceuticals, Inc., a privately held biopharmaceutical company developing anti-inflammatory drugs for chronic and acute diseases, announced today that enrollment has begun in the company's multi-center phase 2 clinical trial (PLASMA -- Phospholipase Levels And Serological Markers of Atherosclerosis). PLASMA is a double-blind, randomized, parallel group, placebo controlled study among subjects with stable coronary artery disease (CAD). Subjects will be randomized to receive either placebo tablets or one of four orally active doses of A-002. A-002 is a potent inhibitor of secretory phospholipase A2 (sPLA2) -- a family of enzymes which lead to the release of damaging free fatty acids and lysophospholipids, both of which play a role in the inflammatory process. The duration of study drug therapy will be eight weeks and approximately 200 patients in 60 sites in the US and Europe will be enrolled.

"This multi-center study is an important aspect of our comprehensive development strategy for our lead cardiovascular compound A-002," commented James Pennington, M.D. Executive Vice President and Chief Medical Officer. "This strategy involves multiple clinical studies and a comprehensive non-clinical program with the goal of providing a new therapeutic approach targeting both vascular inflammation and atherogenic lipid profiles in a large cardiovascular patient population."

There is a growing body of literature implicating sPLA2 in the development of atherosclerosis and increased risk of cardiovascular events. In addition to causing vascular inflammation, sPLA2 is known to have adverse effects on high density lipoproteins (HDL) or so called "good cholesterol," while potentially increasing levels of low density lipoproteins (LDL) or "bad cholesterol." The first data demonstrating the effectiveness of A-002 in treating atherosclerosis in a standard animal model are scheduled to be presented at the Eight Congress on Inflammation, June 16th - 20th, 2007 in Copenhagen, Denmark.

Further information about this clinical trial and atherosclerosis can be found at www.PLASMAtrial.com or www.anthera.com.

About Atherosclerosis

According to the American Heart Association, coronary heart disease affects nearly 14 million people in the United States and more than 30 million worldwide. Atherosclerosis is a disease of the arteries that results from inflammation and the build-up of plaque under the lining of the blood vessel. This build-up can cause vascular swelling and eventual rupture. sPLA2 levels have been shown to be elevated in patients with both stable and unstable coronary artery disease. Higher levels of the enzyme have been shown to predict an increased risk for future cardiovascular events such as heart attacks and stroke.

About Anthera Pharmaceuticals

Anthera Pharmaceuticals is a privately-held pharmaceutical development company committed to world-class development and commercialization of promising clinical products to address the unmet medical needs of patients with life-threatening chronic and acute inflammatory diseases. In 2006, Anthera acquired worldwide rights (except Japan) to a series of clinical and pre-clinical compounds that inhibit the enzymatic activity of members of the phospholipase (PLA2) family -- a group of enzymes responsible for the release of arachidonic acid and subsequent production of leukotrienes‚ prostacyclins and other mediators of inflammation. These highly potent compounds inhibit novel‚ upstream steps in the inflammation cascade and have the potential to address a variety of diseases including: acute chest syndrome, acute lung injury, acute respiratory distress syndrome, atherosclerosis, Acute Coronary Syndrome, chronic obstructive pulmonary disease and psoriasis. In order to efficiently commercialize this platform, Anthera has brought together a proven management team with extensive experience in licensing, clinical research, development, and commercialization of anti-inflammatory products. For more information please visit www.anthera.com.


Source: Anthera Pharmaceuticals

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