EWING, N.J., June 4, 2014 (GLOBE NEWSWIRE) -- Celator Pharmaceuticals, Inc. (Nasdaq:CPXX), a pharmaceutical company developing new and more effective therapies to treat cancer, today announced that it has achieved 75% enrollment in the Company's ongoing Phase 3 clinical study comparing 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). The planned enrollment for the study is 300 patients.
"We are very encouraged by the accelerated pace of patient enrollment in the Phase 3 trial of our lead product candidate, CPX-351, and we believe it reflects the enthusiasm among investigators to improve the clinical benefit of high-risk AML patients," said Scott Jackson, Celator's Chief Executive Officer. "The pre-planned safety analysis of the first 150 patients by the Data and Safety Monitoring Board will take place this month, and we expect to remain on track to complete enrollment in the fourth quarter of this year."
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.
Patient enrollment is expected to complete in the fourth quarter of 2014, which would put the Company on track to report initial data on the secondary endpoint of remission rate in the second quarter of 2015. The primary endpoint, overall survival, is projected to be available in the first quarter 2016.
About the Phase 3 Study
The ongoing Phase 3 multicenter, randomized trial of CPX-351 (Protocol NCT01696084) is designed to study the efficacy of CPX-351 compared to 7+3 as first line therapy in elderly patients with high risk (secondary) AML. The study 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 one of the following:
- Therapy-related AML
- AML with a history of myelodysplasia (MDS)
- AML with a history of chronic myelomonocytic leukemia (CMMoL)
- De novo AML with karyotypic abnormalities characteristic of MDS
Patients are randomized 1:1 to receive either CPX-351 (100 u/m2; Days 1, 3, and 5 by 90 minute infusion) or 7+3 (cytarabine 100 mg/m2/day by continuous infusion for 7 days and daunorubicin 60 mg/m2 on days 1, 2, and 3). The primary efficacy endpoint of the study is overall survival.
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," "believe," "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 safety and efficacy of CPX-351, whether clinical results for CPX-351 obtained to date will be predictive of future clinical study results, 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.
Source:Celator Pharmaceuticals. Inc.