Celator® Pharmaceuticals Presents Data on CPX-351 at the 56th American Society of Hematology Annual Meeting

EWING, N.J., Dec. 10, 2014 /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 the presentation of data on its lead product candidate, CPX-351 (cytarabine:daunorubicin) Liposome for Injection, at the 56^th American Society of Hematology (ASH) Annual Meeting and Exposition in San Francisco, held December 6-9, 2014.

Data were presented from preclinical studies examining the tissue distribution, metabolism and excretion characteristics of cytarabine and daunorubucin administered as CPX-351 compared to the non-liposomal forms of the same drugs. Drug metabolism and excretion were qualitatively similar for both treatments, however, the rates were much slower for CPX-351, and this was accompanied by a marked reduction of early and widespread drug distribution into tissues compared to the free agents. These results are consistent with CPX-351 liposomes directing drug away from most normal tissues and are consistent with an improved safety profile.  Importantly, CPX-351 accumulated and persisted in the bone marrow for over four days at cytarabine and daunorubicin concentrations known to exert anti-leukemic activity against acute myeloid leukemia (AML) blasts. 

"Taken together, these results provide additional biologic rationale supporting the clinical improvements in both efficacy and safety seen for CPX-351, compared to current administration of cytarabine and daunorubicin treatment," said Dr. Lawrence Mayer, President and Chief Scientific Officer at Celator. "We continue to be pleased by the consistency and predictability of our preclinical results with CPX-351 in the context of our observations to date in patients."

Additionally, interim clinical data were presented by Dr. Roland Walter, of the Fred Hutchinson Cancer Research Center and the University of Washington, from an ongoing investigator-initiated study of CPX-351 in adults with untreated high-risk myelodysplastic syndrome (MDS) and AML at high risk of treatment-related mortality.  

In this study, patients were randomized to receive lower doses of CPX-351 at either 32 or 64 units/m2 by 90-minute infusion on days 1, 3, and 5.

The 32 unit/m2 dose level continues to enroll and now has 15 patients. The historical rate of 30-day mortality for patients eligible for the study is reported to be 31%.  The 64 unit/m2 dose level observed a similar rate of 30-day mortality and is thought to be unlikely to reduce the rate further.  Objective responses have been observed at both dose levels.

"Patients who historically were considered 'unfit' to receive intensive chemotherapy are typically at high risk for treatment-related mortality or therapeutic resistance, but there is no agreed upon approach to define these patients. This study is the first of a series of studies that will attempt to define the "unfit" population and how best to use CPX-351 in patients who may not be able to tolerate the dose and schedule used in more intensive treatment regimens," said Dr. Arthur Louie, Chief Medical Officer, at Celator. "It is believed that some form of chemotherapy may improve outcomes, but we continue to see early mortality caused by progressive AML/MDS and treatment-induced toxicities, and these patients are in need of better therapeutic options."

Details on the presentations are as follows:

Title: CPX-351 Markedly Reduces Renal and Hepatic Clearance Rates for Cytarabine (Cyt) and Daunorubicin (Daun) in Rats with an Associated Decrease in Excretory and Metabolic Burden Despite Providing Dramatic Increases in Systemic Drug Exposure Compared to Conventional Cyt+Daun
Abstract # 2305
Session: Acute Myeloid Leukemia: Novel Therapy, excluding Transplantation: Poster II

Title: Quantitative Whole Body Autoradiography (QWBA) Analysis Reveals That CPX-351 Shifts the Exposure of Cytarabine (Cyt) and Daunorubicin (Daun) Away from Many Tissues While Providing Prolonged Exposure to Cytotoxic Drug Concentrations in the Bone Marrow Compared to Conventional Free Drug Administration
Abstract #: 3740
Session: Acute Myeloid Leukemia: Novel Therapy, excluding Transplantation: Poster III

Title: Randomized Study of Liposomal Cytarabine and Daunorubicin (CPX-351) for Adults with Untreated High-Risk Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML) at High Risk of Treatment-Related Mortality
Abstract #: 994
Session: Acute Myeloid Leukemia: Novel Therapy, excluding Transplantation: Poster I

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 until exposure to the tumor following administration.  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; and several programs exploring novel combinations of existing drugs, including molecularly targeted therapies.

For more information, please visit Celator's website at www.celatorpharma.com. Information on ongoing trials is available at www.clinicaltrials.gov.

Forward-Looking Statements:

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," "believe," "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, efficacy and therapeutic potential of CPX-351, our expectations regarding our research and development programs, and expanding our pipeline and advancing our CombiPlex platform.  Forward-looking statements in this release involve substantial risks and uncertainties that could cause our preclinical and clinical development programs and other 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 ongoing and future clinical studies and other matters that could affect the 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, 2013 and other filings by the company with the U.S. Securities and Exchange Commission.

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SOURCE Celator Pharmaceuticals, Inc.

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