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December 12, 2013
08:39 EDTCPXXCelator Pharmaceuticals says DSMB recommends study of CPX-351 continue
Celator Pharmaceuticals announced that the independent Data and Safety Monitoring Board, or DSMB, for the company's Phase 3 clinical study comparing CPX-351 Liposome Injection versus the conventional cytarabine and daunorubicin treatment regimen as first-line therapy in older patients with high-risk acute myeloid leukemia should continue as planned without any modifications. The company said, "We are encouraged by the progress of the study and the DSMB's recommendation. This is the first safety review of available data from the Phase 3 study and we look forward to reporting updates as the study progresses and to completing enrollment of the study in 2014." The DSMB assessment was based on a pre-planned safety analysis on the first 75 randomized patients included in the study with a minimum of 60 days of follow-up. The DSMB will conduct additional periodic reviews after 150 patients, 225 patients and 300 patients become evaluable for safety review.
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