EpiCept, a specialist cancer treatment and pain management company, has filed a New Drug Submission (NDS) with Health Canada for Ceplene, for the treatment of acute myeloid leukaemia (AML) in patients in first complete remission.
Ceplene, (histamine dihydrochloride) is currently approved in the EU, for the remission maintenance and prevention of relapse in patients with AML in first remission.
EpiCept president and CEO Jack Talley said that the NDS filing with Health Canada was a important step in the 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 US Food and Drug Administration (FDA) towards the end of 2009, contingent on planned discussions with the FDA," Talley said.
The company is reportedly negotiating with several prospective partners for the European marketing rights to Ceplene.