Tosedostat: Phase II/III started

CTI said investigators at Cardiff University began the tosedostat plus low-dose cytarabine arm of the open-label, international Phase II/III AML Less Intensive (LI-1) trial in patients ages >60 years with AML or high-risk MDS. The trial is already comparing other treatments with or without cytarabine. The Phase II portion of the trial is expected to enroll 50 patients for each arm, with an additional 50 patients to be enrolled if the complete response rate “appears satisfactory.” The Phase III portion is contingent on an interim analysis of complete response data and would enroll an additional 100 patients in the arm.

AML LI-1 may add other therapies as they become available and is already evaluating quizartinib ( AC220) from Ambit Biosciences Corp. (NASDAQ:AMBI, San Diego, Calif.); ganetespib (formerly STA-9090) from Synta Pharmaceuticals Corp. (NASDAQ:SNTA, Lexington, Mass.); and selinexor ( KPT-330) from Karyopharm Therapeutics Inc. (NASDAQ:KPTI, Natick, Mass.). The National Cancer Research Institute Hematological Oncology Study Group is conducting the trial. ...