CELATOR® PHARMACEUTICALS ANNOUNCES START OF CLINICAL STUDY IN PATIENTS WITH UNTREATED MYELODYSPLASTIC SYNDROME (MDS) OR ACUTE MYELOID LEUKEMIA AT HIGH RISK OF TREATMENT-RELATED MORTALITY
Ewing, N.J. – (August 13, 2013) Celator Pharmaceuticals, Inc., 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 in patients with untreated high-risk myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML), excluding acute promyelocytic leukemia, at high risk of treatment-related mortality.
A recent analysis of 3,365 adults with newly diagnosed AML treated on protocols at Southwest Oncology Group (SWOG) or at MD Anderson Cancer Center (MDA) indicated that the weekly risk of death falls sharply once four weeks elapse from the start of intensive induction chemotherapy. This observation suggests that patients at high-risk for early mortality comprise a qualitatively distinct group and may be defined and objectively identified using an algorithm with a scoring system (TRM score) based on performance status, age, platelet count, albumin, secondary AML, white blood cell count, peripheral blood blast percentage and creatinine. Analysis of the combined SWOG and MDA experience suggests that approximately 20 percent of newly diagnosed adults with AML meet this entry criterion.
To be eligible for the study, patients must have a high TRM score, indicating increased risk for treatment-related mortality. The study, which could enroll up to 90 patients, will evaluate two different doses of CPX-351 in patients deemed at high risk of TRM to determine whether CPX-351 could be an option in these patients. The rationale for evaluating CPX-351 in this protocol is based on two observations from Phase 1 and 2 studies of CPX-351. First, complete response was observed in patients with relapsed or refractory AML at dose levels well below the maximum tolerated dose (MTD), allowing lower doses to be tested in more fragile patients. Second, CPX-351 reduced early mortality among intensively treated newly diagnosed older patients, while retaining the same overall response rates, resulting in a net improvement in survival among high-risk AML patients (most notably in patients with secondary disease).
“The need for efficacious treatments in medically unfit patients with AML or high-risk MDS is unquestioned,” said Roland Walter, MD, PhD, Assistant Member of the Clinical Research Division at the Fred Hutchinson Cancer Research Center, who enrolled the first patient. “Many of these individuals – or elderly patients more generally – are often excluded from curative-intent or even lower-intensity therapy, although the potential benefit of disease-directed therapy is well established. This trial provides an exciting opportunity to test a novel therapy in a patient population that is often neglected in the typical AML trial.”
“As Celator continues to enroll patients in a Phase 3 study in patients with secondary AML, it’s important to evaluate the potential benefit CPX-351 may provide in other patient populations,” said Scott Jackson, chief executive officer of Celator Pharmaceuticals. “Working with investigators at the Fred Hutchinson Cancer Research Center, and potentially other leading centers, will help the company evaluate if CPX-351 offers a benefit in this patient population, a patient population in need of therapeutic improvements.”
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
. Information on ongoing trials is available at
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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