CAMBRIDGE, Mass.--(BUSINESS WIRE)--Xanthus Pharmaceuticals, Inc., today announced that it has initiated patient dosing in a pivotal Phase 3 trial with Xanafide® (amonafide malate) for the treatment of patients with secondary acute myeloid leukemia (sAML). On June 12, 2007, the Company announced the completion of a Special Protocol Assessment (SPA) with the U.S. Food and Drug Administration (FDA) for the design of the Phase 3 trial. Under the SPA agreement, a statistically significant, positive result for this pivotal trial would support an efficacy claim for Xanafide in secondary AML in a New Drug Application (NDA).
