Celator® Pharmaceuticals Announces Expansion of Clinical Study in Patients with Untreated Myelodysplastic Syndrome (MDS) or Acute Myeloid Leukemia (AML) at High-Risk of Treatment-Related Mortality

EWING, N.J., June 8, 2015 /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 an investigator-initiated clinical study evaluating CPX-351 (cytarabine:daunorubicin) Liposome Injection in patients with untreated high-risk myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML), at high risk of treatment-related mortality has met the efficacy and safety criteria to expand the 32units/m² dose cohort. In order to expand the 32units/m² cohort, the protocol requires 5 or more complete responses and fewer than five deaths by day 28 in the first 20 patients. CPX-351 resulted in 6 responses in the first 20 patients with 2 early treatment-related deaths by day 28. CPX-351 surpassed both criteria and the number of patients in the cohort was increased from 20 to 30.

Treatment-related mortality (TRM) is a key contributor to overall survival in high risk MDS and AML. This study is evaluating whether CPX-351 is a practical option in patients deemed at high risk of TRM.  Patients eligible for this study had TRM scores putting them in the 20 percent of patients at highest risk for early mortality. The rationale for evaluating CPX-351 in these patient populations is based on observations from the earlier conducted and completed Phase 1 and 2 studies with CPX-351, whereby complete responses occurred at dose levels well below the dose being used in the Phase 3 study, with a substantial reduction in early mortality, resulting in an improvement in overall survival in certain patient populations.

Risk assessment for TRM is based on an analysis of 3,365 adults with newly diagnosed AML treated on protocols at Southwest Oncology Group (SWOG) or at MD Anderson Cancer Center. TRM scores provide a means for objectively identifying patients at high-risk for early mortality (treatment-related mortality, or TRM score), such that the higher the TRM score, the greater the risk for treatment-related mortality.

"We are happy to report expansion of this study which seeks an active but safe treatment for patients with AML or MDS at high risk for early treatment-related mortality, who are rarely eligible for conventional chemotherapy," said Roland Walter, MD, PhD, Assistant Member of the Clinical Research Division at the Fred Hutchinson Cancer Research Center, the lead investigator for this study. "The early safety and efficacy observations are encouraging and we look forward to continuing to study CPX-351 in these patient populations."  

"As we await the results from the ongoing Phase 3 study in patients with secondary AML, it is important to evaluate the potential benefit of CPX-351 in other patient populations," said Scott Jackson, Chief Executive Officer of Celator Pharmaceuticals. "Working with investigators at leading cancer centers facilitates the broader evaluation of CPX-351 in patient populations in dire need of therapeutic improvements. We are pleased that CPX-351 was selected as one of these potential therapeutic alternatives and are encouraged to see meaningful therapeutic activity of CPX-351 in these patients."

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; 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.

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," "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, whether clinical results for CPX-351 obtained to date will be predictive of future clinical study results, 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, 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, whether the final results of our clinical studies will be supportive of regulatory approval to market CPX-351 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 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.

SOURCE Celator Pharmaceuticals, Inc.

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