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."
In the study, CPX-351 exhibited a safety profile generally comparable to "7+3." The overall frequency of adverse events and grade 3 and 4 adverse events for the cardiac, gastrointestinal, metabolic, skin, respiratory, vascular and nervous systems were similar. Consistent with its much longer half-life, CPX-351 was associated with a longer time to recovery of neutrophils and platelets (approximately 7 days longer). This difference did not affect the early mortality rate which was low for both arms of the study. Early mortality, death within 30 days, is a concern with AML treatments.
"These preliminary data are the first safety and efficacy results from one of our two ongoing randomized Phase 2 studies of CPX-351 in AML," said Scott Jackson, chief executive officer of Celator Pharmaceuticals. "We look forward to completing this study by the end of 2010 and to presenting the final safety and CR data as well as CR duration, event-free survival and survival at 12 months. On the basis of those results and data from our study in adults with AML in first relapse, we will finalize a Phase 3 study design and establish a registration pathway for CPX-351 in AML."
SOURCE Celator Pharmaceuticals