Anthera Pharmaceuticals, Inc., a privately held biopharmaceutical company developing anti-inflammatory drugs, said 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-centre 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, 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."
A-001 is a potent inhibitor of secretory phospholipase A2 (sPLA2) activity‚ including groups IIA‚ V‚ and X. The US 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.
"Today's announcement marks another exciting milestone for Anthera," said Paul F. Truex, president and chief executive officer, Anthera Pharmaceuticals, Inc. "Over the past few months, we've also made significant progress in our A-002 programme 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."