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news.Anthera Pharmaceuticals has announced that after completing its review of safety and efficacy data currently available, an independent data safety monitoring board has recommended the continuation of the company's Phase II clinical trial, known as the Impacts study, without changes in the current protocol.
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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.
James Pennington, executive vice president and chief medical officer of Anthera, said: “We are pleased with the DSMB’s response and look forward to continuing the A-001 trial under our original protocol. 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.”