Celator® Pharmaceuticals Announces Start of Clinical Study of CPX-351 in Pediatric, Adolescent and Y
Celator® Pharmaceuticals Announces Start of Clinical Study of CPX-351 in Pediatric, Adolescent and Young Adult Patients with Relapsed or Refractory Hematologic Malignancies
EWING, N.J.--(BUSINESS WIRE)-- Celator Pharmaceuticals, Inc. (OTCQB:CLPM), a pharmaceutical company developing new and more effective therapies to treat cancer, today announced that the first patient has enrolled in an investigator-initiated clinical study evaluating CPX-351 (cytarabine:daunorubicin) Liposome Injection in pediatric, adolescent and young adult patients with relapsed or refractory hematologic malignancies.
This study will be conducted in two phases: a dose exploration phase and an expanded phase. The study will assess the pharmacokinetics, tolerability, as well as early evidence of efficacy of CPX-351 in pediatric, adolescent and young adult patients with relapsed or refractory hematologic malignancies, which includes acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL) and aggressive lymphoma. Patients will receive a single course of CPX-351 administered on Days 1, 3 and 5. The dose exploration phase, which could enroll 5 to 12 patients, will be used to determine a safe and tolerable dose of CPX-351 in patients between 1 and 21 years of age. After completion of the dose exploration phase of the study, 3 to 18 additional patients between 1 and 30 years of age will be enrolled as part of the expanded phase. The initiation of this study follows data in adult AML patients treated with CPX-351 which suggests high levels of antileukemic activity with acceptable toxicity.
"The experience in adults has been encouraging," said Michael Absalon, MD, PhD, Assistant Professor, Division of Hematology/Oncology at Cincinnati Children's Hospital Medical Center. "The purpose of the clinical trial is to evaluate whether CPX-351 may ultimately be an effective and less toxic alternative to conventional approaches used in the treatment of children and young adults with hematologic malignancies."
"We are excited to be working with Cincinnati Children's Hospital in evaluating the potential benefit of CPX-351 in younger patients with hematologic malignancies," said Scott Jackson, chief executive officer of Celator Pharmaceuticals. "This study reflects our commitment to working with investigators to evaluate CPX-351 in other patient populations with unmet medical need."
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.
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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