EWING, N.J., Feb. 16, 2016 /PRNewswire/ -- Celator Pharmaceuticals, Inc. (Nasdaq: CPXX) today announced that the Phase 3 clinical trial of VYXEOS™ (cytarabine:daunorubicin) Liposome for Injection (also known as CPX-351) in patients with untreated high-risk (secondary) acute myeloid leukemia (AML) has reached its pre-specified number of events required for the analysis of overall survival. The company expects to announce overall survival results later this quarter.
The randomized, controlled, Phase 3 study (Protocol NCT01696084), conducted at 39 centers in the United States and Canada, compared VYXEOS to the conventional cytarabine and daunorubicin treatment regimen (commonly referred to as 7+3) as first-line therapy.
Phase 3 Study with VYXEOS
The study enrolled 309 patients between the ages of 60 and 75 who had pathologically confirmed diagnosis of high-risk AML by WHO criteria including: therapy-related AML, AML with a history of myelodysplasia (MDS), AML with a history of chronic myelomonocytic leukemia (CMMoL), and de novo AML with karyotypic abnormalities characteristic of MDS.
Patients were randomized 1:1 to receive either VYXEOS (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).
The study was conducted in partnership with The Leukemia & Lymphoma Society® (LLS) through its Therapy Acceleration Program (TAP), which has supported the clinical development of VYXEOS beginning in Phase 2.
About Celator Pharmaceuticals, Inc.
Celator Pharmaceuticals, Inc., with locations in Ewing, N.J., and Vancouver, B.C., is a 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 after administration and ensure its exposure to the tumor. Celator's pipeline includes lead product, VYXEOS™ (also known as CPX-351), a liposomal formulation of cytarabine:daunorubicin being studied for the treatment of acute myeloid leukemia; CPX-1, a liposomal formulation of irinotecan:floxuridine being studied for the treatment of colorectal cancer; and a preclinical stage product candidate, CPX-8, a hydrophobic docetaxel prodrug nanoparticle formulation, being studied by the National Cancer Institute's Nanotechnology Characterization Laboratory. The Company is advancing the CombiPlex platform and broadening its application to include molecularly targeted therapies. The Company is seeking research and development collaborations, applying its proprietary technologies, with other biotechnology/pharmaceutical companies.
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 timing of the announcement of the overall survival results from the company's Phase 3 clinical trial of VYXEOS™ (also known as CPX-351), our expectations regarding our research and development programs and advancing our CombiPlex platform and the potential to establish research and development collaborations applying our proprietary technologies with other biotechnology/pharmaceutical companies. Forward-looking statements in this release involve substantial risks and uncertainties that could cause our development programs, future results, 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 clinical studies, whether clinical study results obtained to date will be predictive of future results, whether the final results of our clinical studies will be supportive of regulatory approval to market VYXEOS and other matters that could affect the commercial potential of our drug candidates. Celator undertakes no obligation to update or revise any forward-looking statements. 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, 2014, subsequent reports on Form 10-Q and 8-K, and other filings by the company with the U.S. Securities and Exchange Commission, including, without limitation, the risk factor that the company's clinical studies for VYXEOS may not demonstrate safety or efficacy or lead to regulatory approval.
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