Safety Monitoring Board Recommends To Continue CPX-351 Phase 3 Study

(RTTNews) - Celator Pharmaceuticals, Inc. (CPXX), Thursday said the the independent Data and Safety Monitoring Board or DSMB urged the company to continue its Phase 3 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 or AML, without any changes.

"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." said the company's Chief Medical Officer.

The Safety Board assessment was based on a pre-planned safety analysis on the first 75 patients included in the study with a minimum 60 days of follow-up. The DSMB will also conduct additional periodic reviews after 150 patients, 225 patients and 300 patients become evaluable for safety review.

The Phase 3 study is being conducted in collaboration with The Leukemia & Lymphoma Societythrough its Therapy Acceleration Program, which has supported the development of CPX-351 starting in Phase 2. The primary efficacy endpoint of the study is overall survival.