EpiCept has filed a New Drug Submission (NDS) with Health Canada for Ceplene (histamine dihydrochloride), for the treatment of acute myeloid leukemia (AML) patients in first complete remission.
Ceplene is currently approved in the EU, for the remission maintenance and prevention of relapse in patients with AML in first remission.
Reportedly, the company is continuing negotiations with several prospective partners for the European marketing rights to Ceplene.
Jack Talley, president and CEO of EpiCept, said: “The filing of the NDS for Ceplene with Health Canada is a another key milestone for EpiCept and an important step in our North American regulatory strategy for this innovative new therapy.
“We anticipate that we will also be in the position to file a New Drug Application with the FDA towards the end of this year, contingent upon planned discussions with the FDA,” he added.