Celator Pharma Says DSMB Recommends To Continue Phase 3 Study Of CPX-351

(RTTNews) - Celator Pharmaceuticals Inc. (CPXX) said that the independent Data and Safety Monitoring Board or DSMB for the Company's Phase 3 clinical study of CPX-351 (cytarabine:daunorubicin) Liposome Injection versus the conventional cytarabine and daunorubicin treatment regimen (commonly referred to as 7+3) as first-line therapy in older patients with high-risk (secondary) acute myeloid leukemia or AML has completed a planned safety review and recommended that the study should continue as planned without any modifications.

"We are encouraged by the DSMB recommendation after the safety review of available data from the first 150 patients enrolled in our Phase 3 study of CPX-351.....The study has surpassed 75% of its planned enrollment and we expect to complete enrollment in the fourth quarter of 2014. We now look forward to the next DSMB safety review, which will review the first 225 patients enrolled, in the fourth quarter of this year," said Arthur Louie, Chief Medical Officer of Celator Pharmaceuticals.

The DSMB assessment was based on a pre-planned safety analysis on the first 150 randomized patients included in the study with a minimum of 60 days of follow-up. The DSMB will conduct additional periodic reviews after 225 patients and 300 patients become evaluable for safety review. The company announced in June 2014 that the planned 300-patient clinical study had achieved 75% enrollment.

The Phase 3 study is being conducted in partnership with The Leukemia & Lymphoma Society or LLS through its Therapy Acceleration Program or TAP, which has supported the development of CPX-351 beginning in Phase 2.