On October 19, 2015 Celator Pharmaceuticals, Inc. (NASDAQ: CPXX) trepported 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 (Press release, Celator Pharmaceuticals, OCT 19, 2015, View Source [SID:1234507737]). Schedule your 30 min Free 1stOncology Demo! 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.
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"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.