Celator initiates enrollment for Phase II leukemia trial

The first patient was enrolled by Eric Feldman at the Weill Medical College of Cornell University and New York Presbyterian Hospital. Dr Feldman was an investigator involved in the Phase I study with CPX-351 in patients with advanced leukemias.

The Phase II study will be conducted in patients with newly diagnosed acute myeloid leukemia (AML), greater than or equal to 60 but <76 years of age, who are able to tolerate intensive chemotherapy. This randomized (2:1) study is designed to compare CPX-351 to the conventional method of administering cytarabine and daunorubicin, commonly referred to as '7+3'. The reference '7+3' refers to the administration days of the drugs (cytarabine is administered as a seven day continuous infusion and daunorubicin is administered on days one, two and three). CPX-351 is administered on days one, three and five. The target enrollment is 120 patients. The primary endpoint of the study is complete remission rate. Secondary endpoints are duration of complete remission, time to treatment failure, survival at 12 months, 30, 60, and 90 day mortality and safety and tolerability. Scott Jackson, CEO of Celator, said: "This is an important milestone for Celator and we are excited about the benefit CPX-351 may offer patients. We continue to open new clinical trial sites for participation in this study and we are moving forward with a second randomized Phase II study in patients with AML in first relapse."