DSMB Supports Continuation of Anthera Phase II Impacts Trial for the Prevention of Acute Chest Syndrome in Patients With Sickle Cell Disease |
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By: Anthera Pharmaceuticals, Inc. Posted: 2008-04-16 05:15:26 |
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Anthera Pharmaceuticals, Inc., a privately held biopharmaceutical company developing anti-inflammatory drugs, announced today that after completing its review of safety and efficacy data currently available, 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, without change.
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). "We are pleased with the DSMB's response and 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. "Treatment options are limited for this important patient population and we believe a drug that provides an opportunity for early intervention would help address a significant unmet medical need." "Today's announcement marks another exciting milestone for Anthera," said Paul F. Truex, President and Chief Executive Officer of Anthera Pharmaceuticals, Inc. "Over the past few months, we've also made significant progress in our A-002 program for cardiovascular disease. In February, we completed our end of Phase II meeting with the FDA. In early April, we completed a pre-submission meeting with European Medicines Agency (EMEA). Presently, we are preparing to submit our registration protocols to FDA as part of the Special Protocol Assessment process." 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 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. MEDIA CONTACT: Anne Bowdidge (650) 218-6900 |
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