TARRYTOWN, N.Y.--(BUSINESS WIRE)--Regulatory News: EpiCept Corporation (Nasdaq and Nasdaq OMX Stockholm: EPCT) announced today that it has filed a protocol for a Phase III confirmatory clinical trial for Ceplene® (histamine dihydrochloride) with the U.S. Food and Drug Administration (FDA). The protocol will be reviewed under the FDA’s Special Protocol Assessment (SPA) program under which the FDA will provide formal guidance regarding the trial’s design, clinical endpoints, statistical analysis and labeling claims. EpiCept expects to receive initial comments from the FDA within the next 45 days, and to reach an agreement with the FDA on all major protocol elements later this year. Ceplene is EpiCept’s maintenance therapy for patients with acute myeloid leukemia (AML) in first remission and is currently approved in the European Union and Israel.
