SAN MATEO, Calif., July 2 /PRNewswire/ -- Anthera Pharmaceuticals, Inc., a privately held biopharmaceutical company developing anti-inflammatory drugs for chronic and acute diseases, announced today that enrollment of 200 patients in the phase 2 PLASMA (Phospholipase Levels And Serological Markers of Atherosclerosis) trial has been completed significantly ahead of schedule. The company plans to announce the preliminary results later this year and is evaluating the further expansion of the trial.
PLASMA which began recruiting in April 2007, is a dose-response study designed to evaluate the safety and efficacy of A-002 to reduce secretory phospholipase A2 (sPLA2) activity levels and other well established markers of inflammation and cardiovascular risk in patients with stable coronary artery disease. sPLA2 is a family of enzymes that are part of the inflammation process. The study is being conducted at sites in the US and Europe.
A-002 represents the first product in a class of compounds aimed at suppressing the activity of sPLA2. Animal data regarding the effect of A-002's impact on atherosclerosis and lipids was presented at the 8th Congress on Inflammation in Copenhagen, Denmark on June 19th. Treatment with A-002 resulted in statistically significant reductions in atherosclerosis and cholesterol by 50% and 25% respectively, when compared with the untreated group.
"The completion of enrollment in this trial is a milestone Anthera is pleased to announce as our pipeline of products continues to advance," stated James E. Pennington, MD, Executive Vice President and CMO at Anthera. "The progression of this therapeutic candidate is an example of Anthera's commitment to the development of products that address unmet medical needs of patients with life-threatening chronic and acute inflammatory diseases."
"Due to an excellent rate of accrual we have completed enrollment several months earlier than we had anticipated and look forward to having the results from PLASMA before the end of this year." stated Colin Hislop MD, Senior Vice President for Anthera's cardiovascular products.
In addition to the accelerated enrollment of PLASMA, Anthera has been notified by the University of Toronto that a study protocol utilizing A-002 in patients undergoing percutaneous coronary intervention (PCI) has been approved by Health Canada. This investigator sponsored study, which will enroll 164 patients, is being conducted by Dr. Vladimir Dzavik, President of the Canadian Association of Interventional Cardiology and The Brompton Funds Professor in Interventional Cardiology as well as Director, Cardiac Catheter Laboratory and Interventional Cardiology University Health Network.
Further information about this clinical trial and atherosclerosis can be found at www.PLASMAtrial.com or www.anthera.com.
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.
Contact: Press Relations (650) 931- 8814 pr@anthera.com
Anthera Pharmaceuticals, Inc.CONTACT: Press Relations, +1-650-931-8814, or pr@anthera.com
Web site: http://www.anthera.com//
