The Leukemia & Lymphoma Society (LLS) is providing Celator Pharmaceuticals with a second, $5 million tranche of funding to support a pivotal Phase III study evaluating the firm’s lead acute myeloid leukemia therapy, CPX-351 (cytarabine:daunorubicin) liposome injection. The study will compare CPX-351 with conventional cytarabine plus daunorubicin therapy in elderly patients with untreated secondary AML. Enrollment is expected to start during 2012. Celator previously received $4.1 million from LLS to support an open-label Phase IIb study with CPX-351 comparing CPX-31 therapy with intensive salvage therapy in adult patients with AML in first relapse. Positive data were reported last month both from this trial, and a second open-label Phase IIb study comparing CPX-351 with conventional cytarabine and daunorubicin (7+3 regimen) therapy in patients between the ages of 60-75 years with newly-diagnosed AML.
“This is the first time that LLS has provided follow-on funding to a development partner,” comments Louis DeGennaro, Ph.D., LLS chief mission officer. “The very promising results of our initial collaboration, as well as Celator’s demonstrated ability to pursue its research agenda effectively while working with the FDA to identify an efficient regulatory pathway, give us the confidence to provide an additional $5 millon.”
Celator is exploiting its CombiPlex platform to identify specific ratios of synergistically active drug combinations with optimal efficacy and minimal toxicity against cancer, and encapsulate the drugs at the correct concentrations using a drug delivery vehicle. The platform incorporates high-throughput screening, computer algorithms for synergy analysis, and drug delivery technologies. Lead compound CPX-351 is an infused liposomal formulation of cytarabine:daunorubicin locked in a synergistic 5:1 molar ratio.
A second clinical-stage candidate, CPX-1, is an injected liposomal formulation of a synergistic 1:1 molar ratio of irinotecan HCI and floxuridine, which is in Phase II development as a potential treatment for colorectal cancer. Preclinical work is ongoing with CPX-571, an irinotecan/cisplatin combination, and CPX-8XY, a nanoparticle delivery system for chemotherapy drugs developed in partnership with Princeton University.