Tosedostat: Clinical trial hold

Cell Therapeutics said FDA placed a partial clinical hold on enrollment in trials of once-daily oral tosedostat after a tosedostat-treated patient died of myocarditis. Specifically, the patient received tosedostat plus either azacitidine or cytarabine in an investigator-sponsored, open-label, U.S. Phase I/II trial in patients with relapsed or refractory AML or high-risk MDS. According to the company, the agency requested additional data on the patient that died, a review of all grades of cardiac adverse events or cardiac-related investigations in tosedostat-treated patients and a benefit-risk analysis using the additional data. Cell Therapeutics said it plans to submit the requested data "in the coming weeks." ...