logo
  

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.

For comments and feedback contact: editorial@rttnews.com

Business News

Editors Pick
Hedge-fund billionaire William Ackman's Pershing Square Tontine Holdings Ltd. (PSTH) agreed to acquire 10% of Universal Music Group from French media conglomerate Vivendi (VIV.L, VIVEF.PK) for about $4 billion, the companies said in a statement on Sunday. The 737 MAX 10, Boeing Co.'s largest 737 Max model, is taking its maiden flight today, reports said citing people familiar with the matter. The flight after months of testing and certification will be around 10 a.m. local time from the Seattle area. The schedule could change depending on weather or other factors. Meanwhile, the jetliner is expected to enter commercial service in 2023. Medical devices supplier Smiths Medical, affiliated to Smiths Group plc, is recalling certain Jelco Hypodermic Needle-Pro Fixed Needle insulin syringes with skewed graduation markings, the U.S. Food and Drug Administration said. The recall was initiated after the company became aware of specific models and lots of Jelco insulin syringes that may exhibit skewed odd number line graduation markings.
Follow RTT