EpiCept Corp says that European regulators have given the green light to Ceplene, the US firm’s treatment for adults with acute myeloid leukaemia.

The European Commission has granted a full marketing authorisation in the form of a positive Commission Decision, for Ceplene (histamine dihydrochloride) for the remission maintenance and prevention of relapse in adult patients with AML in first remission. The drug is to be administered in conjunction with low-dose interleukin-2.

The approval is based in part on the results of a 320-patient Phase III trial for Ceplene in conjunction with IL-2 which showed that treatment significantly reduced the occurrence of relapse among AML patients in complete remission. The improvement of long-term leukaemia-free survival in patients receiving Ceplene/IL-2 exceeded 50% and the drug was well tolerated.

The approval allows Ceplene to be marketed in the 27 member states of the European Union, as well as in Iceland, Liechtenstein and Norway. EpiCept has been granted 10 years of market exclusivity in the EU for the treatment, which has orphan drug status.

EpiCept chief executive Jack Talley noted that Ceplene is now the first approved therapy “demonstrated to produce a clear benefit in prolonging leukaemia-free survival and preventing relapse among AML patients”. He added that “several potential commercial partners with established sales infrastructures in haematology and oncology in Europe” have expressed interest in marketing Ceplene and are in "various stages of due diligence".

There are 40,000 AML patients in the EU, with 16,000 new cases occurring each year. Once diagnosed, patients typically receive induction and consolidation chemotherapy, with the majority achieving complete remission. However, about 70%-80% of patients who achieve first remission will relapse, within 12 months. Less than 15% of relapsed patients survive long-term.

As for the North American market, a pre-New Drug Submission meeting with Health Canada for Ceplene has been scheduled during the fourth quarter and will be followed in the first quarter of 2009 by a meeting with the US Food and Drug Administration.