Helsinn and MEI Terminate its P-III Study of Pracinostat for Patients with AML

Shots:

• Interim analysis of the ongoing P-III study of pracinostat + azacitidine in patients with AML who are unfit to receive CT demonstrated that it was unlikely to meet its 1EPs of OS
• Based on the outcome of the interim analysis, the companies will discontinue the ongoing study as the decision is based on a lack of safety & efficacy concern. The companies will continue the other studies of pracinostat
• Pracinostat is an oral HDAC inhibitor, currently being evaluated in P-II study for high/very high-risk MDS and has received the US FDA & EMA’s ODD in combination with azacytidine for AML. Additionally, the US FDA has granted BT designation for the therapy

Click here to read full press release/ article | Ref: Helsinn | Image: Helsinn