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Helsinn, MEI Pharma Discontinue Phase 3 Study With Pracinostat - Quick Facts

Swiss pharma company Helsinn Group and MEI Pharma, Inc. (MEIP) announced Thursday that they have decided to discontinue the recruitment of patients and end the Phase 3 Study with Pracinostat in Acute Myeloid Leukemia (AML) following an interim analysis.

The interim futility analysis demonstrated that it was unlikely to meet the primary endpoint of overall survival compared to the control group.

The decision was based on a lack of efficacy and not on safety concerns. Pending further evaluation, patients currently enrolled in other pracinostat studies will continue treatment.

The interim analysis was conducted for the ongoing Phase 3 study of pracinostat in combination with azacitidine in patients with AML who are unfit to receive standard intensive chemotherapy, undertaken by the study Independent Data Monitoring Committee (IDMC).

AML is a disorder of the blood and bone marrow caused by the uncontrolled proliferation of an abnormal hematopoietic cell of myeloid lineage. This results in a high circulating number of immature blood cells and replacement of normal bone marrow by malignant cells.

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