Celator(R) Pharmaceuticals Announces Publication of Preclinical Data for CPX-351 in Acute Lymphoblastic Leukemia Models

EWING, N.J., Sept. 15, 2014 (GLOBE NEWSWIRE) -- Celator Pharmaceuticals, Inc. (Nasdaq:CPXX), a pharmaceutical company developing new and more effective therapies to treat cancer, today announced the publication of preclinical data in Pediatric Blood & Cancer that further characterize the therapeutic potential of lead compound CPX-351 in hematological malignancies and support its ongoing clinical testing in pediatric patients with ALL. CPX-351 is currently being studied in a pivotal Phase 3 clinical trial in older patients with high risk (secondary) AML.

"Cytarabine and anthracyclines such as daunorubicin are commonly used to treat ALL in pediatric patients, and while these drug are very effective in front-line multidrug combination chemotherapy regimens, there remains room for improvement, especially in pediatric patients who relapse within 36 months of diagnosis," said Professor Richard Lock, Head of the Leukemia Biology Program at Children's Cancer Institute, Sydney Australia, and senior author on the paper. "We are very encouraged by these preclinical results, indicating that the proprietary CPX-351 formulation of cytarabine and daunorubicin may be an important tool to maximize efficacy outcomes in relapsed ALL, and we believe these data substantiate the need for additional, clinical study in pediatric patients."

The publication titled, "Efficacy of CPX-351, (Cytarabine:Daunorubicin) Liposome Injection, Against Acute Lymphoblastic Leukemia Xenograft Models of the Pediatric Preclinical Testing Program," appeared in the peer-reviewed medical journal, Pediatric Blood & Cancer [doi: 10.1002/pbc.25133, http://onlinelibrary.wiley.com/doi/10.1002/pbc.25133/abstract].

The efficacy of CPX-351 was studied against a panel of aggressive and chemoresistant childhood ALL xenograft models developed at the Children's Cancer Institute as part of the United States National Cancer Institute-funded Pediatric Preclinical Testing Program. The results show that CPX-351 administered at 5 units/kg demonstrated potent anti-leukemic activity in vivo and was highly efficacious against all xenograft models tested, inducing complete responses in four B-lineage xenografts and a partial response in one T-lineage xenograft. The dose used provided clinically relevant plasma drug exposure and correlated to the pharmacokinetic properties observed in patients with AML.

"We are very pleased with these study results and believe they support our decision to evaluate CPX-351 in additional hematological malignancies beyond secondary AML," commented Dr. Lawrence Mayer, President, Founder and Chief Scientific Officer of Celator Pharmaceuticals. "CPX-351 has demonstrated broad activity across a variety of cancers and in high-risk patient populations, and we hope to continue to evaluate its potential in childhood leukemias, where the prognosis is still poor in certain patient subsets."

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; 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 a program exploring novel combinations of existing drugs, including targeted therapies.

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 safety, tolerability, efficacy and therapeutic potential of CPX-351, whether clinical results for CPX-351 obtained to date will be predictive of future clinical study results, our expectations regarding our development plans for CPX-351 and our other drug candidates or whether final results of clinical studies will be supportive of regulatory approvals required to market licensed products. 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.

CONTACT: Media: Mike Beyer Sam Brown, Inc. 773-463-4211 beyer@sambrown.com Investors: Beth DelGiacco Stern Investor Relations, Inc. (212) 362-1200 beth@sternir.com

Source:Celator Pharmaceuticals, Inc.