Following Encouraging Results Anthera to Continue IMPACTS Trial for the Prevention of Acute Chest Syndrome in Patients With Sickle Cell Disease
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)”Å¡ fever”Å¡ 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.
“Today’s announcement marks an exciting milestone for Anthera and more importantly, the sickle cell patient population,” said
A-001 is a potent inhibitor of secretory phospholipase A2(sPLA2) activity”Å¡ including groups IIA”Å¡ V”Å¡ 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
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.”Å¡ Ltd. worldwide rights (excluding
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SOURCE Anthera Pharmaceuticals, Inc.