Celator® Pharmaceuticals Announces New Data On Factors Associated With Outcomes In AML Patients Treated With CPX-351

Princeton, N.J. – (June 3, 2013) Celator Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company developing new and more effective therapies to treat cancer, today announced that a new analysis of data from two randomized Phase 2 studies of CPX-351 (cytarabine:daunorubicin) Liposome Injection in patients with acute myeloid leukemia (AML) has confirmed the consistent activity of CPX-351 and identified several prognostic factors for outcomes in the studies.  The results were presented at the American Society of Clinical Oncology 2013 Annual Meeting in Chicago, IL (ASCO Abstract #7100).
“Both of these Phase 2 studies demonstrated that CPX-351 can improve outcomes, particularly by significantly extending survival in high-risk patients, compared to standard therapy,” said Dr. Eric Feldman, Director of Hematological Malignancies, Weill Cornell Medical Center, an author of the study.  “Our analysis provides important additional information about the factors that affect survival in patients treated with CPX-351 and may be helpful in identifying patients who may benefit from CPX-351.”
The multivariate analysis was performed on data from Study 204, which compared CPX-351 to conventional cytarabine and daunorubicin therapy (“7+3”) in patients, 60-75 years of age, with newly-diagnosed AML, and Study 205, which compared CPX-351 to intensive salvage therapy in patients, 18-65 years of age, with AML in first relapse.  In both studies, CPX-351 increased day-14 bone marrow hypoplasia, produced higher complete response rates (CR+CRi), significantly improved survival in high-risk patients (those with secondary AML or first relapse AML with unfavorable risk), and improved 60-day mortality.
Results of the analysis suggest that the same three factors significantly impacted overall survival, event-free survival, and 60-day mortality.  These include adverse cytogenetic risk, an indicator of the aggressiveness of the disease and its responsiveness to therapy, low baseline albumin levels (hypoalbuminemia), a gauge of patient fitness for therapy, and the stage of disease at initiation of therapy, with first-line therapy producing higher response rates and longer durations of response.
“These data provide additional confirmation that the most significant difference in survival between CPX-351 and conventional therapy is seen in high-risk patients but, as with most treatments, the greatest benefit is produced in healthier patients with earlier stage disease,” said Scott Jackson, chief executive officer of Celator Pharmaceuticals. “The first observation provided the rationale for our Phase 3 study in patients with secondary AML, which is enrolling, and the second observation suggests the broader potential utility of CPX-351 in the treatment of AML.”

About CPX-351

CPX-351 (cytarabine:daunorubicin) Liposome Injection 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 U.S. Food and Drug Administration (FDA) for the treatment of acute myeloid leukemia (AML). CPX-351 is currently in Phase 3 clinical development for the treatment of patients with secondary AML. 

About Celator Pharmaceuticals, Inc.

Celator Pharmaceuticals, Inc., with locations in Princeton, N.J., and Vancouver, B.C., is a 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 clinical stage 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 product, 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. For more information, please visit the company’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 potential efficacy and therapeutic potential of CPX-351, whether clinical results for CPX-351 obtained to date will be predictive of future clinical study results, and our expectations regarding our development plans for CPX-351 and our drug candidates. 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 future clinical studies, enrollment in clinical studies, availability of data from ongoing clinical studies, expectations for regulatory approvals, 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, 2012 and other filings by the company with the U.S. Securities and Exchange Commission.
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