Celator To Continue AML Trial

The independent Data and Safety Monitoring Board (DSMB) for Celator Pharmaceuticals‘ Phase III trial comparing 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 (AML) has ruled that the trial should continue as planned without any modifications.

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.

The Phase III trial 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 II.

The study is currently enrolling patients between the ages of 60 and 75 who have pathological diagnosis of AML according to WHO criteria (with at least 20% blasts in the peripheral blood or bone marrow) with confirmation of: therapy-related AML, AML with a history of myelodysplasia (MDS), AML with a history of chronic myelomonocytic leukemia (CMMoL), or De novo AML with karyotypic abnormalities characteristic of MDS.