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Celator Pharmaceuticals, Inc. Initiates Pharmacokinetic And Pharmacodynamics Clinical Study Of CPX-351



8/19/2014 7:22:34 AM

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EWING, N.J., Aug. 19, 2014 (GLOBE NEWSWIRE) -- Celator Pharmaceuticals, Inc. (Nasdaq:CPXX), a pharmaceutical company developing new and more effective therapies to treat cancer, today announced that the first patient has been enrolled in a Phase 2 pharmacokinetic and pharmacodynamics (PK/PD) study evaluating the effects of CPX-351 (cytarabine:daunorubicin) Liposome Injection on cardiac repolarization in adult patients with acute hematologic malignancies, including acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), and myelodysplastic syndrome (MDS). This study will also include patients with moderate baseline hepatic and renal impairment, extending the range of safety and pharmacokinetic observations to this important group of patients.

"We continue to work expeditiously to bring CPX-351 before the FDA as a potential new treatment option for patients with acute hematologic malignancies," said Scott Jackson, Chief Executive Officer of Celator Pharmaceuticals. "The FDA requires clinical pharmacology studies for new drugs in development, so we are pleased to have this Phase 2 study underway to support our plans for a NDA submission. We expect to report top-line results from this study in the second half of 2015. "

The open-label, single-arm, Phase 2 study is a thorough PK/PD assessment designed to: (1) measure the effects of CPX-351 on cardiac repolarization following the first induction cycle of CPX-351, (2) assess the impact of moderate hepatic impairment on cytarabine and daunorubicin pharmacokinetics, and (3) assess the impact of moderate renal impairment on cytarabine and daunorubicin pharmacokinetics. The study is expected to enroll 36 patients. Each patient will receive a first induction of CPX-351 on days 1, 3 and 5 and, if necessary, a second induction for patients with reduced leukemia/MDS burden not yet achieving a leukemia/MDS-free state. Responding patients are eligible for up to four consolidation courses. Analysis of treatment impact on cardiac electrophysiology, as measured by the QTc interval, and PK assessments will be performed only following the first induction course.

"Patients with high-risk leukemias are long overdue for an FDA approved anti-leukemic agent that is both safe and effective for high risk leukemias," said S. Eric Rubenstein, M.D., Medical Director of Cancer Research Services at Franciscan St. Francis Health, who enrolled the first patient. "The majority of patients we encounter in the community have a high-risk form of acute leukemia, so we are eager to work with Celator on their novel therapeutic, CPX-351, which is being studied in this important cohort."

The Phase 2 study is being conducted to support the U.S. Food and Drug Administration (FDA) requirements of a NDA for CPX-351.

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 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 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, the availability of data from clinical studies, 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

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