EU gives positive opinion on EpiCepts Ceplene in AML

EpiCept have received a positive opinion from the CHMP for Ceplene (histamine dihydrochloride), for the remission maintenance and prevention of relapse in adult patients with Acute Myeloid Leukemia (AML) in first remission.

EpiCepts Ceplene improves Leukemia Free Survival in Acute Myeloid Leukemi

Data presented at the European Hematology Association Congress show EpiCept’s Histamine H2 agonist Ceplene to improve leukemia free survival (LFS) in acute myeloid leukemia (AML) patients.

EpiCept re-file Ceplene in Europe

EpiCept have filed re-examination MAA documents in Europe for Ceplene, its histamine dihydrochloride compound that is intended for the remission maintenance and prevention of relapse in patients with Acute Myeloid Leukemia (AML). The EU CHMP previously issued a negative opinion, requiring further mechanistic data