EpiCept must conduct new Phase III trial for Ceplene in AML
This article was originally published in Scrip
EpiCept will have to conduct a new Phase III trial with a primary endpoint of overall survival for its lead drug candidate, Ceplene (histamine dihydrochloride), in order to secure US FDA approval for its use as remission maintenance therapy for patients with acute myeloid leukaemia (AML) in first complete remission.
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