The Leukemia & Lymphoma Society and Celator Pharmaceuticals Announce
$5 Million Partnership to Support Phase 3 Development of CPX-351 for AML
-- Agreement represents first time LLS has provided follow-on funding to an existing
TAP partner --
WHITE PLAINS, NY and PRINCETON, NJ (July 2, 2012) - 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 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.
About Acute Myeloid Leukemia (AML)
The 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 LLS, in 2012 approximately 12,950 new cases of AML will be diagnosed in North America and 9,050 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, Hodgkin's disease and myeloma, and improve the quality of life of patients and their families. LLS funds lifesaving blood cancer research around the world and provides free information and support services.
Founded in 1949 and headquartered in White Plains, NY, LLS has chapters throughout the United States and Canada. To learn more, visit www.LLS.org or contact the Information Resource Center at (800) 955-4572, Monday through Friday, 9 a.m. to 6 p.m. ET.
About Celator Pharmaceuticals, Inc.
Celator Pharmaceuticals, Inc., with locations in Princeton, NJ, and Vancouver, BC, is a privately held pharmaceutical company developing new and more effective therapies to treat cancer. CombiPlex®, the company's proprietary drug ratio technology platform, represents a novel approach that identifies molar ratios of drugs that will deliver a synergistic benefit, and locks the desired ratio in a nano-scale drug delivery vehicle that maintains the ratio in patients with the goal of improving clinical outcomes. The company pipeline includes two Phase 2 products; CPX-351 (a liposomal formulation of cytarabine:daunorubicin) for the treatment of acute myeloid leukemia and CPX-1 (a liposomal formulation of irinotecan:floxuridine) for the treatment of colorectal cancer; a preclinical stage compound, CPX-571 (a liposomal formulation of irinotecan:cisplatin); and multiple research programs, including the hydrophobic docetaxel prodrug nanoparticle (HDPN) formulation being studied by the National Cancer Institute's Nanotechnology Characterization Laboratory. Based on the applications of CombiPlex and the proprietary nanoparticle prodrug delivery platform, Celator is positioned to advance a broad pipeline of cancer therapies involving both previously approved and novel drug agents. For more information, please visit the company's website at www.celatorpharma.com. Information on ongoing trials is available at www.clinicaltrials.gov.