Following Encouraging Results Anthera Pharmaceuticals, Inc. to Continue IMPACTS Trial for the Prevention of Acute Chest Syndrome in Patients With Sickle Cell Disease
HAYWARD, Calif., March 24 /PRNewswire/ -- Anthera Pharmaceuticals, Inc., a privately held biopharmaceutical company developing anti-inflammatory drugs, announced today that after completing its review of safety and efficacy data from the first cohort of 30 patients, an independent Data Safety Monitoring Board (DSMB) has recommended that Anthera's Phase II clinical trial, known as the IMPACTS (Investigation of the Modulation of Phospholipase in Acute ChesT Syndrome) Study can continue under the current protocol based on favorable interim results.
IMPACTS is a Phase II multi-center clinical trial evaluating the safety and effectiveness of intravenous A-001 (varespladib sodium) in preventing the development of acute chest syndrome in hospitalized sickle cell disease patients. Enrolled patients are at-risk for acute chest syndrome based on the combination of pain (vaso-occlusive crisis)‚ fever‚ and elevated serum level of the enzyme (secretory phospholipase or sPLA2). Acute chest syndrome is a life-threatening complication of sickle cell disease and one of the most common causes of death in this population.
"We look forward to continuing the A-001 trial under our original protocol," said Dr. James E. Pennington, M.D., Executive Vice President and Chief Medical Officer of Anthera Pharmaceuticals, Inc. "We believe a drug that is deemed to be safe and able to suppress inflammation by inhibiting sPLA2 provides an opportunity for early intervention for patients where current treatment options are limited."
"Today's announcement marks an exciting milestone for Anthera and more importantly, the sickle cell patient population," said Paul F. Truex, President and Chief Executive Officer of Anthera Pharmaceuticals, Inc. "We are pleased with the continued progress of our varespladib clinical programs for cardiovascular and sickle cell disease where inflammation plays a fundamental role in patient outcomes. We look forward to reviewing data from our FRANCIS clinical trial in the second quarter that will provide further insight into the potential role of varespladib's anti-inflammatory activity in preventing secondary major adverse cardiovascular events following an Acute Coronary Syndrome (ACS) event."
About A-001
A-001 is a potent inhibitor of secretory phospholipase A2(sPLA2) activity‚ including groups IIA‚ V‚ and X. The U.S. Food and Drug Administration granted A-001 orphan drug status for the prevention of acute chest syndrome in patients with sickle cell disease in December 2007.
About varespladib (A-002) and Acute Coronary Syndrome
A-002 (varespladib) is a potent inhibitor of secretory phospholipase A2(sPLA2) activity, which in two previously completed studies demonstrated benefits to a variety of biomarkers, including those typically indicative of inflammation. Presently A-002 is being examined in patients with acute coronary syndrome (ACS) for a reduction in secondary MACE. ACS is a heart condition characterized by chest pain occurring at rest or upon minimal exertion. This condition is also referred to as unstable angina. If the chest pain is associated with heart muscle damage and heart tracing abnormalities, it is typically classified as a heart attack or myocardial infarction.
About Anthera Pharmaceuticals
Anthera Pharmaceuticals is a privately-held company committed to developing and commercializing clinical pharmaceutical products that address unmet medical needs of patients with life-threatening, chronic and acute inflammatory diseases and autoimmune disorders. The Company has acquired from Eli Lilly and Company and Shionogi & Co.‚ Ltd. worldwide rights (excluding 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. The company has also acquired exclusive and worldwide rights to a peptide fusion protein, A-623, for the treatment of systemic lupus erythematosus (SLE) and other autoimmune diseases from Amgen. For more information, please visit http://www.anthera.com.
CONTACT: Anne Bowdidge, +1-650-218-6900, pr@anthera.com, for Anthera
Pharmaceuticals, Inc.
Web site: http://www.anthera.com/