EpiCept Corporation announced that the European Commission has granted a full marketing authorization in the form of a positive Commission Decision, for Ceplene (histamine dihydrochloride) for the remission maintenance and prevention of relapse in adult patients with Acute Myeloid Leukemia (AML) in first remission. Ceplene is to be administered in conjunction with low-dose interleukin-2 (IL-2). The approval allows Ceplene to be marketed in the 27 member states of the European Union (EU), as well as in Iceland, Liechtenstein and Norway.

"It marks a significant and welcome milestone for patients suffering from AML," stated Jack Talley, president and CEO of EpiCept. "Ceplene is now the first approved therapy demonstrated to produce a clear benefit in prolonging leukemia-free survival and preventing relapse among AML patients. We are proud that this new therapeutic option will be available to physicians and patients in 30 countries."

The approval by the European Commission is based, in part, on the results of the pivotal 320-patient phase-III trial for Ceplene in conjunction with IL-2. The primary result of this trial was that treatment with Ceplene/IL-2 significantly reduced the occurrence of relapse among AML patients in complete remission. The improvement of long-term leukemia-free survival in patients receiving Ceplene/IL-2 exceeded 50 per cent. Moreover, Ceplene was well tolerated in this patient population and conferred an acceptable risk benefit profile for 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. The combination of Ceplene and IL-2 has been demonstrated to be a safe therapy that improves leukemia-free survival by significantly reducing the risk of recurrent leukemia. Therefore, the approval granted for Ceplene is an important step forward in making the treatment available to AML patients," said Mats Brune, associate professor at Sahlgrenska University and principal investigator of the Ceplene phase-III clinical trial.

"Ceplene improves the capacity of the patients' immune cells to attack and destroy malignant cells," said Kristoffer Hellstrand, 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."

As a result of its designation as an Orphan Medical Product, EpiCept has been granted 10 years of market exclusivity in the EU for Ceplene. As part of receiving marketing authorization under Exceptional Circumstances for Ceplene, EpiCept will perform two post-approval clinical studies. 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 is considering combining these studies into a single clinical trial.

Talley continued, "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. We expect to share further details on our commercialization strategy later this year."

EpiCept has also advanced its efforts to gain approval for Ceplene as a remission maintenance treatment for AML patients in North America. A pre-New Drug Submission meeting with Health Canada has been scheduled during the fourth quarter of 2008, and will be followed in the first quarter of 2009 by a pre-New Drug Application meeting with the United States Food and Drug Administration.

Ceplene is EpiCept's proprietary product approved for the treatment of AML.

EpiCept is focused on unmet needs in the treatment of cancer and pain.