Celator Pharmaceuticals today announced that the first patient has been treated in a randomized Phase 2 clinical study of CPX-351 (Cytarabine:Daunorubicin) Liposome Injection in patients with newly diagnosed acute myeloid leukemia (AML).
The first patient was enrolled by Eric Feldman, MD at the Weill Medical College of Cornell University and New York Presbyterian Hospital. Dr. Feldman was an investigator involved in the Phase 1 study with CPX-351 in patients with advanced leukemias. "We are pleased to be involved in this Phase 2 study based on the encouraging results seen in the Phase 1 study," said Dr. Feldman. "It's important to develop new treatment options for patients and CPX-351 incorporates two of the most active agents used in the treatment of AML."
CPX-351 is a liposomal formulation of cytarabine and daunorubicin delivered in a 5:1 molar ratio shown in preclinical studies to represent a synergistic ratio for use in combination chemotherapy. CPX-351 represents a new approach to developing drug combinations in which drug ratios are pre-selected based on synergistic anti-tumor activity observed preclinically and where the ratios are maintained in patients through Celator's proprietary CombiPlex(R) technology platform.
The Phase 2 study will be conducted in patients with newly diagnosed 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 7 day continuous infusion and daunorubicin is administered on days 1, 2 and 3). CPX-351 is administered on days 1, 3 and 5. 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.
Interim Phase 1 data with CPX-351, where complete remissions were obtained in patients with advanced leukemia, were reported in December 2007. Additional Phase 1 and preclinical data were accepted for presentation at the upcoming American Society of Hematology (ASH) meeting in San Francisco in December.