Ceplene® will be used to maintain remission and prevent relapse.

The European Commission has given the go-ahead to EpiCept to market Ceplene® for the remission maintenance and prevention of relapse in adult patients with acute myeloid leukemia (AML) in first remission. The approval allows Ceplene to be marketed in the 27 member states of the European Union (EU) as well as Iceland, Liechtenstein, and Norway.

Additionally the company is evaluating its partnering options for marketing the drug in the EU. “Several potential commercial partners with established sales infrastructures in hematology and oncology in Europe have expressed interest in marketing Ceplene and are in various stages of due diligence,” says Jack Talley, president and CEO. “We expect to share further details on our commercialization strategy later this year.”

Ceplene is designated an orphan medical product and will thus have 10 years of market exclusivity in the EU. As part of receiving marketing authorization under exceptional circumstances, EpiCept will perform two post-approval clinical investigations. One of the studies will seek to further elucidate the clinical pharmacology of Ceplene by assessing certain biomarkers in AML patients in first remission. The other study will assess the effect of Ceplene/IL-2 on the development of minimal residual disease in the same patient population. EpiCept says that it may combine the two programs.

EpiCept reports that it is also advancing its efforts to gain approval for Ceplene as a remission maintenance treatment for AML patients in North America. A pre-NDA submission meeting with Health Canada has been scheduled for later this year, and will be followed by a similar meeting with the FDA in the first quarter of 2009.

Ceplene will be used in combination with low-dose interleukin-2 (IL-2). Results of a 320-patient Phase III trial of this regimen showed a reduction in relapse among AML patients in complete remission, according to EpiCept.

“Ceplene improves the capacity of the patients’ immune cells to attack and destroy malignant cells,” explains Kristoffer Hellstrand, M.D., Ph.D., professor at the University of Gothenburg, Sweden, and the discoverer of the Ceplene technology. “Ceplene/IL-2 therapy is intended to eliminate residual AML cells, which are the cause of relapse in AML patients.”

“The main challenge in AML treatment is to protect patients in their first complete remission from relapse, as a first relapse is associated with poor long-term survival,” according to Mats Brune, M.D., associate professor at Sahlgrenska University and principal investigator of the Ceplene Phase III study.

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