Celator® Pharmaceuticals Announces Positive Recommendation From Data And Safety Monitoring Board For Phase 3 Study Of CPX-351 (VYXEOS™) – Company expects Overall Survival Data in First Quarter of 2016 –
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 p-rpelanned 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™ (CP-X351), 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