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

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