Celator Pharmaceuticals announced results from its Phase 2 trial of CPX-351 (cytarabine and daunorubicin) Liposome Injection for the treatment of adult patients with acute myeloid leukemia (AML). The randomized, open-label study enrolled 126 patients between the ages of 60-75 years with newly-diagnosed AML at 18 sites in the United States and Canada. Patients were stratified as high risk (age 70 or older, secondary AML, or ≥3 chromosomal abnormalities) or standard risk (all other patients). Following randomization, 85 patients received CPX-351 and 41 received the “7+3” regimen.
Compared to patients in the “7+3” arm, patients treated with CPX-351 demonstrated a higher aplasia rate, a higher remission rate (including complete remissions [CR] and complete remissions with incomplete neutrophil/platelet recovery [CRi]), lower induction mortality, improved median event-free survival (EFS), and improved median overall survival (OS).
CPX-351 is a combination of two drugs with synergistic anti-tumor activity (cytarabine and daunorubicin); these drugs are encapsulated in a liposome injection drug delivery vehicle in order to maintain the desired drug molar ratio following administration.
For more information call (609) 243-0123 or visit www.celatorpharma.com.