Anthera Receives FDA Approval to Begin Phase 2 'PLASMA' Trial With A-002 for Patients With Coronary Atherosclerosis

Jan 04, 2007, 00:00 ET from Anthera Pharmaceuticals

    SAN MATEO, Calif., Jan. 4 /PRNewswire/ -- Anthera Pharmaceuticals,
 Inc., a privately held biopharmaceutical company developing
 anti-inflammatory drugs for chronic and acute diseases, announced today
 that the US Food and Drug Administration has approved its Investigational
 New Drug (IND) application for its lead cardiovascular compound A-002. As a
 result of this approval, Anthera will initiate a multi-center phase 2
 clinical trial (PLASMA -- Phospholipase Levels And Serological Markers of
 Atherosclerosis) that will examine the effect of A-002 on secretory
 phospholipase A2 (sPLA2) levels and other well established markers of
 inflammation and cardiovascular risk in patients with stable coronary
 artery disease due to underlying atherosclerosis. PLASMA is expected to
 complete enrollment by the fourth quarter of 2007.
     sPLA2 is a family of enzymes that hydrolyze phospholipids leading to a
 chronic inflammatory response and harmful changes to serum lipid profiles.
 A-002 represents the first product in a class of compounds aimed at
 suppressing the activity of sPLA2. Recent animal data regarding A-002's
 impact on atherosclerosis, lipids, and inflammation will be presented at
 the 8th Congress on Inflammation in Copenhagen, Denmark, June 16th, 2007.
     "The clinical burden of cardiovascular disease is large and will
 continue to grow over the coming decades. PLASMA is our first step on a
 path to provide a new option for patients who remain in need of more
 advanced therapies to treat their underlying vascular disease," stated
 Colin Hislop MD, Senior Vice President Clinical Development. "With
 increasing focus on chronic inflammation in patients with atherosclerosis,
 A-002 provides a potential new therapeutic approach to suppress
 inflammation, improve lipid profiles, and hopefully improve patient
     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.
     "PLASMA is intended to determine whether inhibition of sPLA2, an
 important trigger of the inflammatory response, can reduce systemic levels
 of inflammatory markers known to be predictors of coronary heart disease
 events. This study will serve as a basis for future trials that investigate
 the effects of sPLA2 inhibition on atherosclerosis progression and
 cardiovascular events," stated Robert S. Rosenson, M.D., Professor of
 Medicine and Director, Lipoprotein Disorders and Clinical Atherosclerosis
 Research, Division of Cardiovascular Medicine at the University of Michigan
 and the Principal Investigator for the PLASMA trial.
     Further information about this clinical trial and atherosclerosis can
 be found at or .
     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 .
      Press Relations
      (510) 277-1208

SOURCE Anthera Pharmaceuticals