EWING, N.J., June 11, 2014 (GLOBE NEWSWIRE) -- Celator Pharmaceuticals, Inc. (Nasdaq:CPXX), a pharmaceutical company developing new and more effective therapies to treat cancer, today announced that the independent Data and Safety Monitoring Board (DSMB) for the Company's Phase 3 clinical study of CPX-351 (cytarabine:daunorubicin) Liposome Injection versus the conventional cytarabine and daunorubicin treatment regimen (commonly referred to as 7+3) as first-line therapy in older patients with high-risk (secondary) acute myeloid leukemia (AML) has completed a planned safety review and recommended that the study should continue as planned without any modifications.
"We are encouraged by the DSMB recommendation after the safety review of available data from the first 150 patients enrolled in our Phase 3 study of CPX-351," said Arthur Louie, Chief Medical Officer of Celator Pharmaceuticals. "The study has surpassed 75% of its planned enrollment and we expect to complete enrollment in the fourth quarter of 2014. We now look forward to the next DSMB safety review, which will review the first 225 patients enrolled, in the fourth quarter of this year."
The DSMB assessment was based on a pre-planned safety analysis on the first 150 randomized patients included in the study with a minimum of 60 days of follow-up. The DSMB will conduct additional periodic reviews after 225 patients and 300 patients become evaluable for safety review. The Company announced in June 2014 that the planned 300-patient clinical study had achieved 75% enrollment.
The Phase 3 study is being conducted in partnership with The Leukemia & Lymphoma Society® (LLS) through its Therapy Acceleration Program (TAP), which has supported the development of CPX-351 beginning in Phase 2.
"We are pleased with the progress of the Phase 3 study," said Scott Jackson, Chief Executive Officer of Celator Pharmaceuticals. "In addition to the Phase 3 study, we are working with investigators to study CPX-351 in other AML patient populations, as well as in other hematologic malignancies, with the hope of providing improved clinical benefits to these patients."
The study (Protocol NCT01696084) is currently enrolling patients between the ages of 60 and 75 who have pathological diagnosis of AML according to WHO criteria (with at least 20% blasts in the peripheral blood or bone marrow) with confirmation of:
- Therapy-related AML,
- AML with a history of myelodysplasia (MDS),
- AML with a history of chronic myelomonocytic leukemia (CMMoL), or
- De novo AML with karyotypic abnormalities characteristic of MDS.
Patients are randomized 1:1 to receive either CPX-351 (100u/m2; days 1, 3, and 5 by 90 minute infusion) or 7+3 (cytarabine 100mg/m2/day by continuous infusion for 7 days and daunorubicin 60mg/m2 on days 1, 2, and 3). Patients are monitored for all clinical adverse events as well as laboratory evaluations. The primary efficacy endpoint of the study is overall survival. The study is being conducted in the United States and Canada, with more than 40 leading cancer centers participating.
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, our expectations for completion of enrollment in our Phase 3 clinical study and the availability of clinical data, and statements regarding the safety, efficacy and therapeutic potential of CPX-351. 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 this and 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.