The Leukemia & Lymphoma Society Accelerates Milestone Payment Associated with the Phase 3 Study of CPX-351 in High Risk (Secondary) AML
- This is part of the existing $5 Million Therapy Acceleration Program partnership -
- Accelerated payment based on recently reported positive induction response rate -
Jun 29, 2015, 08:00 ET
WHITE PLAINS, N.Y. and EWING, N.J., June 29, 2015 /PRNewswire/ -- Celator Pharmaceuticals, Inc. (Nasdaq: CPXX) today announced 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).
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.
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."
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.
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. Patients should contact the Information Resource Center at (800) 955-4572, Monday through Friday, 9 a.m. to 9 p.m. ET.
About Celator Pharmaceuticals, Inc.
Celator Pharmaceuticals, Inc., with locations in Ewing, N.J., and Vancouver, B.C., is a late-stage clinical stage biopharmaceutical company that is transforming the science of combination therapy, and developing products to improve patient outcomes in cancer. Celator's proprietary technology platform, CombiPlex®, enables the rational design and rapid evaluation of optimized combinations incorporating traditional chemotherapies as well as molecularly targeted agents to deliver enhanced anti-cancer activity. CombiPlex® addresses several fundamental shortcomings of conventional combination regimens, as well as the challenges inherent in combination drug development, by identifying the most effective synergistic molar ratio of the drugs being combined in vitro, and fixing this ratio in a nano-scale drug delivery complex to maintain the optimized combination after administration and ensure its exposure to the tumor. Celator's pipeline includes lead product, CPX-351 (a liposomal formulation of cytarabine:daunorubicin) for the treatment of acute myeloid leukemia; CPX-1 (a liposomal formulation of irinotecan:floxuridine) for the treatment of colorectal cancer; and a preclinical stage product candidate, CPX-8 (a hydrophobic docetaxel prodrug nanoparticle formulation), being studied by the National Cancer Institute's Nanotechnology Characterization Laboratory. The company is advancing the CombiPlex platform and broadening its application to include molecularly targeted therapies and epigenetic modulators.
For more information, please visit Celator's website at www.celatorpharma.com. Information on ongoing trials is available at www.clinicaltrials.gov.
To the extent that statements contained in this press release are not descriptions of historical facts regarding Celator, they are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "expect," "anticipate," "estimate," "intend," and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. Examples of forward-looking statements contained in this press release include, among others, statements regarding the potential safety, tolerability, efficacy and therapeutic and commercial potential of CPX-351, our expectations regarding our development plans for CPX-351 and our other drug candidates, the availability of data from clinical studies, and whether final results of clinical studies will be supportive of regulatory approvals required to market licensed products. Forward-looking statements in this release involve substantial risks and uncertainties that could cause our clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in the conduct of clinical studies, availability of data from ongoing clinical studies, expectations for regulatory submissions and approvals, whether clinical study results for CPX-351 obtained to date will be predictive of future results, and other matters that could affect the availability or commercial potential of our drug candidates. Celator undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of the company in general, see Celator's Form 10-K for the year ended December 31, 2014 and other filings by the company with the U.S. Securities and Exchange Commission.
SOURCE Celator Pharmaceuticals, Inc.
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