Celator Hits 50% Enrollment in AML Trial

Celator Pharmaceuticals has reached 50% enrollment in its Phase III study 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). Planned enrollment is 300 patients.

The Phase III 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 II.

The study (Protocol NCT01696084) 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 one of the following:

• Therapy-related AML
• AML with a history of myelodysplasia (MDS)
• AML with a history of chronic myelomonocytic leukemia (CMMoL)
• De novo AML with karyotypic abnormalities characteristic of MDS

The primary efficacy endpoint of the study is overall survival. The study is being conducted in the U.S. and Canada with approximately 40 cancer centers participating. Patient enrollment is expected to be complete in 4Q14. Initial data from the study, on secondary endpoints such as remission rate and selected safety data, could be available in 2Q15. The primary endpoint, overall survival, is projected to be available in 1Q16.