Celator Pharmaceuticals today announced that interim safety and efficacy data from its Phase 2 multicenter, randomized, open-label clinical trial of CPX-351 (Cytarabine:Daunorubicin) Liposome Injection versus conventional cytarabine and daunorubicin therapy ("7+3") in patients 60-75 years of age with untreated acute myeloid leukemia (AML) were presented at the 51st American Society of Hematology (ASH) Annual Meeting in New Orleans, Louisiana (ASH Abstract # 1033).
The presentation included data from the first 85 evaluable patients, 57 treated with CPX-351 and 28 treated with "7+3." Investigators reported that the complete remission (CR) rate for the CPX-351 arm was 61.4 percent versus 50.0 percent for the "7+3" arm.
"These interim observations are encouraging, even with the relatively small patient numbers," said Jeffrey E. Lancet, M.D., associate professor, H. Lee Moffitt Cancer Center. "If the final results of this study show that CPX-351 significantly improves the response rate and, more importantly, that these responses are durable and correlate with extended survival, we may have an opportunity to challenge the standard of care we've relied on for 30 years."