US FDA stands firm with new trial arm for EpiCept's Ceplene in AML
This article was originally published in Scrip
Following a meeting with the US FDA, EpiCept has confirmed it will have to include an interleukin-2 (IL-2) monotherapy arm in its additional Phase III trial investigating its lead drug candidate, Ceplene (histamine dihydrochloride), in combination with a low-dose IL-2 for the remission maintenance and prevention of relapse of patients with acute myeloid leukaemia (AML) in first complete remission. Scrip understands that the company now hopes to submit an amended protocol by year end.
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