EWING, N.J., Dec. 1, 2014 /PRNewswire/-- Celator Pharmaceuticals, Inc. (NASDAQ: CPXX), a biopharmaceutical company that is transforming the science of combination therapy and developing products to improve patient outcomes in 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 for 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 continue as planned without any modifications.
“We are pleased with the DSMB recommendation to continue with the pivotal Phase 3 study of CPX-351 following this safety analysis of the first 225 randomized patients, out of a total of 309 patients who were enrolled in the study,” said Arthur Louie, Chief Medical Officer of Celator Pharmaceuticals. “With the Phase 3 study having recently completed enrollment ahead of schedule, we look forward to the induction response rate analysis, which we expect in the second quarter of 2015.”
The DSMB assessment was based on a pre-planned safety analysis on the first 225 randomized patients included in the study with a minimum of 60 days of follow-up. The DSMB will conduct an additional review after all patients become evaluable for safety review.
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 excited with the progress of the Phase 3 study,” said Scott Jackson, Chief Executive Officer of Celator Pharmaceuticals. “In addition to the induction response rate data, a secondary endpoint, from the study in the second quarter of next year, we expect the overall survival data, the primary endpoint, in the first quarter of 2016. We also continue to work 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) enrolled patients between the ages of 60 and 75 who have pathological diagnosis of AML according to WHO criteria 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 were 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 clinical stage biopharmaceutical company that is transforming the science of combination therapy, and developing products to improve patient outcomes in cancer. Celator’s proprietary technology platform, CombiPlex®, enables the rational design and rapid evaluation of optimized combinations incorporating traditional chemotherapies as well as molecularly targeted agents to deliver enhanced anti-cancer activity. CombiPlex addresses several fundamental shortcomings of conventional combination regimens, as well as the challenges inherent in combination drug development, by identifying the most effective synergistic molar ratio of the drugs being combined in vitro, and fixing this ratio in a nano-scale drug delivery complex to maintain the optimized combination until exposure to the tumor following administration. Celator’s 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 several programs exploring novel combinations of existing drugs, including molecularly targeted therapies.
For more information, please visit Celator’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 regarding the availability of clinical data, statements regarding the safety, efficacy, and therapeutic potential of CPX-351 and our expectations regarding our research and development programs and expanding our pipeline and advancing our CombiPlex platform. Forward-looking statements in this release involve substantial risks and uncertainties that could cause our preclinical and 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.
To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/celator-pharmaceuticals-announces-data-and-safety-monitoring-board-recommendation-to-continue-phase-3-study-of-cpx-351-300002420.html
SOURCE Celator Pharmaceuticals, Inc.
Help employers find you! Check out all the jobs and post your resume.
