EWING, N.J., Oct. 19, 2015 /PRNewswire/ -- Celator Pharmaceuticals, Inc. (NASDAQ: CPXX) 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 (now referred to as VYXEOS™) has completed the final pre-planned safety review of all patients and has again recommended the study continue as planned without any modifications.
The Phase 3 study compares VYXEOS versus the conventional cytarabine and daunorubicin treatment regimen (commonly referred to as 7+3) as first-line therapy in older patients with high-risk (e.g. secondary) acute myeloid leukemia (AML). The primary endpoint for the study is overall survival, which the company expects to report in the first quarter of 2016.
"Our confidence in the safety profile of VYXEOS is further strengthened with each positive DSMB recommendation," said Arthur Louie, Chief Medical Officer of Celator Pharmaceuticals. "The conduct of the Phase 3 study has gone remarkably well, having achieved each milestone on time or ahead of schedule. This final confirmation of safety for the Phase 3 study is a major step in the development of VYXEOS for patients with poor prognosis AML."
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 clinical development of VYXEOS beginning in Phase 2.
Additional Information about the Phase 3 Study
The study (Protocol NCT01696084) enrolled 309 patients between the ages of 60 and 75 who have pathological diagnosis of high-risk 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 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). Patients are monitored for all clinical adverse events as well as laboratory evaluations. The study is being conducted in the United States and Canada.
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 after administration and ensure its exposure to the tumor. Celator's pipeline includes lead product, VYXEOS™ (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; 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.
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 safety, potential efficacy and therapeutic potential of VYXEOS™ (CPX-351), the availability of data from clinical studies, and our expectations regarding our research and development programs. Forward-looking statements in this release involve substantial risks and uncertainties that could cause our 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 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, availability of data from ongoing clinical studies 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. 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 and other filings by the company with the U.S. Securities and Exchange Commission.
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SOURCE Celator Pharmaceuticals, Inc.