EWING, N.J., Jan. 12, 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 the publication of Phase 2 data evaluating CPX-351 in adult patients with first-relapse acute myeloid leukemia (AML) in Cancer, a peer-reviewed journal of the American Cancer Society. The study manuscript entitled, "Phase 2, Multicenter, Randomized Trial of CPX-351 (cytarabine:daunorubicin) Liposome Injection Versus Intensive Salvage Therapy in Adults With First Relapse AML," appears in the January 15, 2015 issue.
The published data suggest a clinical benefit from CPX-351 in first relapse AML patients and demonstrate a clear clinical benefit in those with poor-risk disease as defined by the European Prognostic Index (EPI). Along with the previously published results from the Phase 2 study of CPX-351 in newly diagnosed patients with AML, these data support Celator's Phase 3 study of CPX-351 as a first-line therapy in older patients with high-risk (secondary) AML. Our Phase 3 study, which is being conducted in partnership with The Leukemia & Lymphoma Society® recently completed enrollment.
"Patients with first relapse AML have generally a poor prognosis, with a limited likelihood of response following salvage treatment. This is particularly true for patients classified by the EPI as poor-risk upon entering the trial," said Jorge Cortes, M.D., Lead Investigator and Deputy Chair of the Department of Leukemia at The MD Anderson Cancer Center. "We were very pleased to see promising response rates in this difficult-to-treat population, and we eagerly await results from Celator's pivotal Phase 3 study of CPX-351, which could fulfill a considerable unmet need in AML."
The randomized, controlled Phase 2 study enrolled 125 patients, aged 18-65, from 35 centers in the U.S., Canada, and Europe diagnosed with AML in first relapse after an initial complete remission lasting for one month or longer. Patients were randomized 2:1 to receive CPX-351 (100 u/m2; days 1, 3, and 5 by 90-minute infusion) or investigators' choice of first salvage chemotherapy. Control salvage treatment was usually based on cytarabine and an anthracycline, often with one or more additional agents. The primary endpoint for the study was survival at one year post treatment.
Patients were stratified per the EPI into favorable, intermediate, and poor-risk groups based on duration of first complete remission, cytogenetics, age, and transplant history, and were well-balanced between the control and the treatment arms. Results showed improved efficacy following CPX-351 and the protocol-defined EPI-poor-risk subset demonstrated statistically significant improvement in overall survival (HR, 0.55; P=0.02), improvement in event-free survival (HR, 0.63; P=0.08) and higher response rate (39.3% vs 27.6%). Additionally, 60-day mortality was lower in the CPX-351 study arm for poor-risk patients (16.1% vs 24.1%).
Treatment with CPX-351 was associated with well-characterized and manageable adverse events. Compared to the control arm, CPX-351 was associated with more frequent hematologic adverse events.
"The insights from this Phase 2 study were very relevant as we designed our Phase 3 pivotal study in older patients with secondary AML, from which initial results, induction response rate, are expected in the second quarter of 2015," commented Arthur C. Louie, Chief Medical Officer of Celator Pharmaceuticals. "There is a clear need for a therapy with better response rates and lower early mortality than what current first-line and salvage therapies provide, and we hope to be able to offer this with CPX-351."
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.
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 potential of CPX-351, our expectations as to the availability of clinical data, whether clinical results for CPX-351 obtained to date will be predictive of future clinical study results, and our expectations regarding our research and development plans for CPX-351 and our other drug candidates and 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 future clinical studies, enrollment in clinical studies, availability of data from ongoing clinical studies, whether final results of clinical studies will be supportive of regulatory approvals required to market licensed products, 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, 2013 and other filings by the company with the U.S. Securities and Exchange Commission.
SOURCE Celator Pharmaceuticals, Inc.