Synta Pharmaceuticals announced that the first patient has been treated in a Phase 1 single agent trial of elesclomol in acute myeloid leukemia (AML). This trial will enroll up to 36 patients with relapsed or refractory AML and total baseline serum LDH level ≤0.8 upper limit of normal (ULN). Patients will be treated with elesclomol sodium on a once-weekly schedule at a starting dose of 200mg/m2, with dose escalation planned based on safety and tolerability. The primary endpoints are to characterize the safety and tolerability of elesclomol sodium and to determine the pharmacokinetics of elesclomol and its metabolites in this patient population. Secondary endpoints include assessing the activity of elesclomol as a monotherapy in the treatment of AML.
Elesclomol is a first-in-class investigational drug candidate that triggers programmed cell death (apoptosis) in cancer cells through a novel mechanism: targeting mitochondrial energy production in cancer cells.
For more information call (781) 274-8200 or visit www.syntapharma.com.