On June 29, 2015 Celator Pharmaceuticals reported that The Leukemia & Lymphoma Society (LLS) is accelerating a portion of the final payment linked to the Phase 3 study of CPX-351 (cytarabine:daunorubicin) liposome injection, Celator’s lead product candidate, for the treatment of patients with high-risk (secondary) acute myeloid leukemia (AML) (Press release, Celator Pharmaceuticals, JUN 29, 2015, View Source [SID:1234505999]). Schedule your 30 min Free 1stOncology Demo! LLS has moved forward payment of $400,000 originally attached to the final overall survival analysis milestone and added it to the milestone payment for induction response rate analysis, thereby increasing the payment from the original amount of $500,000 to $900,000. This brings the total LLS funding paid to date associated with the Phase 3 study to $4.9 million.
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The financial support provided by the LLS Therapy Acceleration Program (TAP) has been important in expediting the completion of the Phase 3, multicenter trial of CPX-351 versus conventional cytarabine plus daunorubicin in older patients with untreated high risk (secondary) AML. Enrollment in the study was completed ahead of schedule, and positive induction response results were announced earlier this month. The overall survival results, the primary endpoint of the study, are expected in the first quarter of 2016. This study is planned to support a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) expected in the second half of 2016.
"We continue to be very pleased with the progress and positive outcomes Celator has achieved with the development of CPX-351," said Louis DeGennaro, Ph.D., LLS’s chief executive officer. "We felt it appropriate to accelerate our payments to assist Celator in completing the activities necessary to file the NDA with the FDA as soon as possible once the overall survival data become available. We are optimistic for a successful outcome of the Phase 3 study and want to help accelerate the availability of promising therapies such as CPX-351 to these patients who are in dire need of improved outcomes."
As part of a 2009 partnership, LLS provided $4.1 million to help fund Celator’s Phase 2 clinical development program, which included two randomized, controlled studies. The positive results from those two studies were used to help design the current Phase 3 study. LLS’s TAP program 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 additional funding comes at an opportune time," said Scott Jackson, Celator’s chief executive officer. "With the recent announcement of positive induction response rate results for our Phase 3 study, we continue to move forward with our preparations for an NDA filing and ultimately commercialization of CPX-351 in the United States. These activities will benefit from the earlier availability of TAP funds and with positive overall survival results in our Phase 3 study, CPX-351 will be available to AML patients as soon as possible. Our partnership with LLS, which began back in 2008, has been extremely productive towards that end."
About CPX-351
CPX-351 (cytarabine:daunorubicin) Liposome for Injection represents an innovative approach to developing combinations of drugs, in which drug molar ratios with synergistic anti-tumor activity are co-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 U.S. Food and Drug Administration and the European Commission for the treatment of Acute Myeloid Leukemia (AML). Celator has conducted two randomized, controlled, Phase 2 studies with CPX-351. The first study was conducted in newly diagnosed elderly AML patients and the second study was conducted in patients with AML in first relapse. In both Phase 2 studies, treatment with CPX-351 resulted in significant improvements in response rates, 60-day mortality, and overall survival in the highest risk patients. The Leukemia & Lymphoma Society has partnered with Celator in the development of CPX-351 starting in Phase 2 and continuing in Phase 3.
About Acute Myeloid Leukemia (AML)
LLS defines AML as a quickly progressing disease in which too many immature white blood cells (not lymphocytes) are found in the blood and bone marrow. According to Cancer Facts and Figures, in 2015 approximately 20,830 new cases of AML will be diagnosed in the United States and 10,460 deaths will occur from the disease.
About The Leukemia & Lymphoma Society
The Leukemia & Lymphoma Society (LLS) is the world’s largest voluntary health agency dedicated to blood cancer. The LLS mission: Cure leukemia, lymphoma, multiple myeloma, and improve the quality of life of patients and their families. LLS funds lifesaving blood cancer research around the world, provides free information and support services, and is the voice for all blood cancer patients seeking access to quality, affordable, coordinated care.