Celator Completes Enrollment For CPX-351 Trial

Celator Pharmaceuticals has completed enrollment in its phase 2 multicenter, randomized, open-label clinical trial of CPX-351 (Cytarabine:Daunorubicin) Liposome Injection, versus conventional cytarabine and daunorubicin therapy. It was conducted in patients 60-75 years of age with untreated acute myeloid leukemia (AML).

The company said that CPX-351 represents a new approach to combination therapy for cancer in which synergistic molar ratios of combined drugs are encapsulated in a drug delivery vehicle, in order to maintain the desired ratio following administration.

According to the company, the phase 2 study enrolled patients with newly diagnosed AML, 60-75 years of age, who were able to tolerate intensive chemotherapy. This study is designed to compare CPX-351 to the standard of care, commonly referred to as 7+3.

The company said that the primary endpoint of the study is complete remission rate. Secondary endpoints are duration of complete remission, event free survival, survival at 12 months, rate of stem cell transplant, 30, 60 and 90 day mortality, and safety and tolerability.

The company plans to release interim safety and complete remission data from the first 80 evaluable patients. In addition to the clinical study results, data will also be presented on the improved selectivity of CPX-351 for leukemic cells over normal bone marrow cells.

Scott Jackson, CEO of Celator Pharmaceuticals, said: “We are grateful to the patients who have entered this study and to the investigators and their teams whose enthusiasm and commitment made it possible to complete enrollment ahead of schedule. We look forward to presenting our first look at the data – what we hope will be additional evidence of the benefits of CPX-351 in this patient population – later this year at the American Society of Hematology.”