EWING, N.J., March 26, 2014 (GLOBE NEWSWIRE) -- Celator Pharmaceuticals, Inc. (Nasdaq: CPXX ), a pharmaceutical company developing new and more effective therapies to treat cancer, today announced that patients have been enrolled in an investigator-initiated clinical study evaluating CPX-351 (cytarabine:daunorubicin) Liposome Injection as a treatment for patients with higher risk myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML), who are refractory to or in relapse after hypomethylating agent (HMA) therapy.
"Disease progression after hypomethylating agent treatment in patients with MDS and AML signals poor prognosis. As a consequence, Celator is extending the use of CPX-351 as a potential treatment for patients no longer responsive to HMA therapy in a clinical trial that will be led by investigator Bruno C. Medeiros at the Stanford University School of Medicine," said Arthur C. Louie, Chief Medical Officer of Celator Pharmaceuticals. "We are delighted to support proposals from investigators for studying indications beyond secondary AML."
The Phase 2 study is expected to enroll up to 33 patients, with the primary objective being to determine the efficacy and safety profile of CPX-351 in patients 60 years of age and older with higher risk MDS or AML. Patients must have progressed after prior HMA therapy. This includes patients older than 75 years of age with higher risk MDS who are HMA relapsed/refractory who have progressed to AML, as well as AML patients with relapsed/refractory disease after prior HMA therapy for AML. Patients will receive a first induction of CPX-351 on days 1, 3, and 5 and, if a morphological leukemia-free state is not achieved, they will receive a second course of induction therapy. After one or two inductions, patients achieving complete remission (with or without blood count recovery) will receive consolidation therapy with CPX-351 on days 1 and 3.
Secondary endpoints include the duration of remission, overall survival at 12 months and early mortality within 60 days of first induction.
"We continue to be excited by the interest from investigators in evaluating CPX-351 in broader patient populations," said Scott Jackson, Chief Executive Officer of Celator Pharmaceuticals. "We believe there is significant potential for CPX-351 as a treatment for other hematologic malignancies beyond secondary AML, the indication being studied in the ongoing Phase 3 study, and remain committed to exploring this further."
About Celator Pharmaceuticals, Inc.
Celator Pharmaceuticals, Inc., with locations in Ewing, 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; and preclinical stage product candidates, including CPX-571 (a liposomal formulation of irinotecan:cisplatin), and 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, 2013 and other filings by the company with the U.S. Securities and Exchange Commission.
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