July 14, 2015 – Celator Pharmaceuticals Inc.
July 14, 2015, EWING, N.J. /PRNewswire/ — Celator Pharmaceuticals, Inc. (Nasdaq:CPXX), a biopharmaceutical company that is transforming the science of combination therapy and developing products to improve patient outcomes in cancer, today announced that patients have been enrolled in an investigator-initiated Phase 2 clinical study evaluating CPX-351 (cyatarabine:daunorubicin) Liposome Injection as a treatment for patients with newly diagnosed Acute Myeloid Leukemia (AML) at high risk for induction treatment mortality.
“Patients with newly diagnosed AML at increased risk of early death urgently need safer and more effective treatment,” said Jorge Cortes, M.D., Deputy Department Chair, Department of Leukemia, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center. “Our earlier experiences with CPX-351 in newly diagnosed and first relapse AML patients make us optimistic about this trial.”
Phase 2 studies with CPX-351 observed improved efficacy and reduced early mortality in the majority of patients studied directly supporting evaluating CPX-351 in this population of newly diagnosed AML patients at high risk for induction treatment mortality.
The Phase 2 study will enroll up to 55 patients, with the primary objective to assess the preliminary efficacy and safety of multiple dose levels of CPX-351 in patients with newly diagnosed AML at high risk for induction treatment mortality. High risk for induction treatment mortality is defined as 30%-50% predicted risk of expiring by day 60. Estimation of risk for induction treatment mortality will be based on factors associated with lower likelihood of AML response with or without factors that reduce tolerance to treatment-associated adverse events. Every patient must have at least one AML-related factor (adverse cytogenetics, secondary AML, MDR phenotype, etc.) that contributes to elevated risk of induction treatment mortality. Patients may or may not have patient-related factors (poor performance status, co-morbidities, poor organ function, etc.) that also contribute to elevated risk of induction treatment mortality.
“We are pleased that Dr. Cortes and MD Anderson Cancer Center chose to study CPX-351 in this patient population,” said Arthur Louie, Chief Medical Officer of Celator Pharmaceuticals. “As we await overall survival data from our CPX-351 Phase 3 trial in patients with high-risk AML, we believe there is significant potential for CPX-351 in other AML populations as well as other blood cancers, and we believe it important to evaluate these opportunities.”
About Celator Pharmaceuticals, Inc.
Celator Pharmaceuticals, Inc., with locations in Ewing, N.J., and Vancouver, B.C., is a 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; 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.
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 safety, potential efficacy and therapeutic potential of CPX-351, the availability of data from clinical studies, and our expectations regarding our research and development programs, expanding our pipeline and advancing our CombiPlex platform. Forward-looking statements in this release involve substantial risks and uncertainties that could cause our clinical development programs, future results, working capital 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 future clinical studies, enrollment in clinical studies, whether clinical study results for CPX-351 obtained to date will be predictive of future results, availability of data from ongoing clinical studies and other matters that could affect the commercial potential of our drug candidates, our ability to raise capital and the trading of our common stock. 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 Celator in general, see Celator’s Form 10-K for the year ended December 31, 2014 and other filings by Celator with the U.S. Securities and Exchange Commission.
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