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The Leukemia & Lymphoma Society and Celator Pharmaceuticals Announce $5 Million Partnership to Support Phase 3 Development of CPX-351 for AML
Date:7/2/2012

WHITE PLAINS, N.Y. and PRINCETON, N.J., July 2, 2012 /PRNewswire/ -- The Leukemia & Lymphoma Society® (LLS) and Celator Pharmaceuticals, Inc. today announced a significant expansion of their partnership to support clinical development and potential registration of Celator's lead product candidate CPX-351 (Cytarabine:Daunorubicin) Liposome Injection for treatment of adults with acute myeloid leukemia (AML).

Under the new agreement, LLS will provide $5 million in funding, through its Therapy Acceleration Program (TAP), for the pivotal, phase 3, multicenter trial of CPX-351 versus conventional cytarabine plus daunorubicin in elderly patients with untreated secondary AML. Celator will provide the balance of funding for the study through its own financing activities.  Enrollment in the study is expected to begin later this year. Should the results confirm that CPX-351 improves overall survival in this patient population, the study will be used to support a New Drug Application (NDA) for CPX-351 in this indication with the U.S. Food and Drug Administration (FDA).

"This is the first time that LLS has provided follow-on funding to a development partner," said Louis DeGennaro, Ph.D., LLS's 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 million to make CPX-351 available to patients with AML as soon as possible."As part of a 2009 partnership, LLS provided $4.1 million to help fund Celator's Phase 2B multicenter, randomized, open-label trial of CPX-351 versus intensive salvage therapy in adult patients 18-65 years of age with AML in first relapse. The positive results of that trial plus the survival advantage observed in a simi
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SOURCE The Leukemia & Lymphoma Society
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