Celator Pharmaceuticals announced that the first patient has been treated in its Phase 2 multicenter, randomized, open-label clinical trial of CPX-351 (Cytarabine:Daunorubicin) Liposome Injection versus intensive salvage therapy in adult patients (up to 60 years old) with acute myeloid leukemia (AML) in first relapse. The study will enroll up to 120 patients between the ages of 18 and 60 who have pathological confirmation of relapsed AML after an initial complete response to prior therapy lasting at least one month. The primary efficacy endpoint of the study is the comparison of overall survival at 1 year between the two arms. Secondary endpoints include complete remission (CR) rate and duration, event-free survival, aplasia rate, and rate of transfer for stem cell transplant.
CPX-351 represents a new approach to treatment, where synergistic molar ratios of combined drugs are encapsulated in a drug delivery vehicle in order to deliver and maintain the desired ratio following administration.
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