Celator Pharmaceuticals Inc., a biopharmaceutical company that is transforming the science of combination therapy and developing products to improve patient outcomes in cancer, announced that the independent Data and Safety Monitoring Board (DSMB) for the Company’s Phase 3 clinical study of CPX-351 (cytarabine:daunorubicin) Liposome for 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 (AML), has completed a planned safety review and recommended that the study continue as planned without any modifications.
“We are pleased with the DSMB recommendation to continue with the pivotal Phase 3 study of CPX-351 following this safety analysis of the first 225 randomized patients, out of a total of 309 patients who were enrolled in the study,” said Arthur Louie, Chief Medical Officer of Celator Pharmaceuticals. “With the Phase 3 study having recently completed enrollment ahead of schedule, we look forward to the induction response rate analysis, which we expect in the second quarter of 2015.”
The DSMB assessment was based on a pre-planned safety analysis on the first 225 randomized patients included in the study with a minimum of 60 days of follow-up. The DSMB will conduct an additional review after all patients become evaluable for safety review.
The Phase 3 study is being conducted in partnership with The Leukemia & Lymphoma Society (LLS) through its Therapy Acceleration Program (TAP), which has supported the development of CPX-351 beginning in Phase 2.
“We are excited with the progress of the Phase 3 study,” said Scott Jackson, Chief Executive Officer of Celator Pharmaceuticals. “In addition to the induction response rate data, a secondary endpoint, from the study in the second quarter of next year, we expect the overall survival data, the primary endpoint, in the first quarter of 2016. We also continue to work with investigators to study CPX-351 in other AML patient populations, as well as in other hematologic malignancies, with the hope of providing improved clinical benefits to these patients.”
Source: Celator Pharmaceuticals