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On September 4th, Innate Pharma (Euronext: IPH.PA) issued a press release announcing regulatory approval for a Phase II trial for the anti-KIR antibody IPH2102. The trial will test the drug as a maintenance therapy for elderly AML patients. IPH2102 is being developed in collaboration with Bristol-Myers Squibb (NYSE: BMY).
Phase II Trial for Acute Myeloid Leukemia. Innate Pharma announced regulatory approval for a Phase II trial for IPH2102 in patients with Acute Myeloid Leukemia (AML). Study IPH2102-201, also known as the EffiKIR trial, will be a randomized, double-blind, placebo controlled study of IPH2102 (also referred to as BMS-986015) as a maintenance treatment in elderly AML patients during their first complete remission. The trial is designed to enroll 150 patients who will be randomized into three different experimental arms. Two arms of the trial will test different doses of IPH2102 and patients in the third arm will receive placebo.
The primary efficacy endpoint for this clinical trial is leukemia-free survival. Secondary endpoints for the study include safety and overall survival. The trial will be conducted in France and patient enrollment is expected to begin before the end of 2012.