The Leukemia & Lymphoma Society and Celator Pharmaceuticals Announce $5 Million Partnership
The Leukemia & Lymphoma Society (LLS) and Celator Pharmaceuticals, Inc announced a significant expansion of their partnership to support clinical development of Celator's CPX-351 (cytarabine:daunorubicin) liposome injection for treatment of adults with acute myeloid leukemia (AML).
The Leukemia & Lymphoma Society (LLS) and Celator Pharmaceuticals, Inc 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 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 similar study conducted by Celator in newly diagnosed elderly patients with secondary AML supported the initiation of the current Phase 3 program. LLS's TAP supports private sector and academic-based projects with the goal of advancing investigational therapies with high prospects for providing near-term benefit to patients with blood cancers.
"This is not only welcome funding but also an important vote of confidence in the potential of CPX-351 to improve outcomes for patients with AML from an organization devoted to that goal," said Scott Jackson, chief executive officer, Celator Pharmaceuticals. "Our new agreement extends what has already been a very productive collaboration and we look forward to the day when these efforts culminate in making a much-needed new treatment option available to patients with AML at large."
CPX-351 represents a new approach to developing combinations of drugs in which drug molar ratios with synergistic anti-tumor activity are encapsulated in a drug delivery vehicle in order to maintain the desired ratio following administration. CPX-351 has been granted orphan drug status by the FDA for the treatment of AML. CPX-351 is in late-stage clinical development for the treatment of AML. Celator has completed a successful randomized, phase 2 study comparing CPX-351 to the standard "7 3" regimen of cytarabine:daunorubicin in patients 60 years of age up to and including 75 years of age with newly diagnosed AML and has also completed a randomized, phase 2 study of CPX-351 versus intensive salvage therapy in patients 18 years of age up to and including 65 years of age with AML in first relapse. The second study was supported by the original LLS TAP funding.