Ceplene histamine dihydrochloride regulatory update

EpiCept said it and FDA reached an agreement for the biotech to conduct an open-label Phase III trial comparing Ceplene histamine dihydrochloride plus low-dose IL-2 vs. standard of care to resolve all outstanding issues related to an NDA for Ceplene to maintain remission and prevent relapse in patients with acute myelogenous leukemia (AML) in first complete remission. In August, FDA refused to file an NDA for Ceplene in combination with low-dose IL-2 for the indication after the agency said that the application did not demonstrate the compound's "therapeutic contribution" in combination with IL-2 (see BioCentury, Aug. 30). ...