Update on new clinical developments and other initiatives related to Ceplene

Dec 15 2009

EpiCept Corporation (Nasdaq and OMX Nordic Exchange: EPCT) today provided an update on new clinical developments and other initiatives related to Ceplene® (histamine dihydrochloride), the Company’s therapy approved in the European Union for the remission maintenance and prevention of relapse of patients with acute myeloid leukemia (AML) in first remission.

EpiCept announced plans to initiate two new studies for Ceplene and provided an update on another study for Ceplene intended to help achieve an expanded indication and broaden use for the drug. These studies include:

• A Phase I/II study that will research the effects of a regimen of Ceplene and low-dose interleukin-2 (IL-2) in combination with Gleevec^® (imatinib mesylate) on the eradication of minimal residual disease (MRD) in adult patients with chronic myeloid leukemia. The study will be led by the Nordic Chronic Myeloid Leukemia Study Group (NCMLSG), which is comprised of physicians and researchers in Sweden, Denmark, Norway and Finland. The primary objective of the study will be to assess the safety of the combination therapy of Ceplene/IL-2 with Gleevec given for six months and to assess the number of patients achieving and subsequently maintaining disease-free survival after discontinuation of Gleevec. Patients will be followed for a minimum of 18 months after discontinuation of Gleevec therapy. MRD will be followed using a specific market resulting from a chromosomal abnormality found in CML.
• The initiation of a study led by GFM (Groupe Francophone des Myélodysplasies) that will examine the effects of Ceplene/IL-2 in combination with Vidaza^® (azacitidine) in the treatment of patients with higher risk myelodsyplastic syndromes (MDS), a bone marrow disease that can progress to AML. These patients will already have demonstrated a hematological response to Vidaza. This trial will be followed by a randomized Phase II study of the efficacy, safety and tolerability of the addition of Ceplene/IL-2 to Vidaza compared to Vidaza alone in patients with higher risk MDS and who have achieved hematological response to Vidaza.
• The post-approval clinical study of Ceplene initiated in July 2009 that is studying the effects of remission maintenance therapy with Ceplene/IL-2 on MRD in adult patients with AML in first complete remission. This open-label, multicenter study will also assess the quantitative and qualitative pharmacodynamic effects of Ceplene/IL-2 on these patients by monitoring T and natural killer cell phenotypes and their functionality after the first and third treatment cycles. Enrollment in this study is ongoing and the study will enroll up to 150 patients at approximately 25 centers across Europe with sites in Sweden, Belgium, France, the U.K., Spain and Italy.

EpiCept also announced today that the first meeting of the Scientific Advisory Board (SAB) it established in collaboration with the European LeukemiaNet Foundation took place on November 18, 2009. The SAB, comprised of 10 key opinion leaders in AML and who collectively practice in all of the major countries in the European Union, gathered to formulate strategies to increase physician awareness and education of the benefits of Ceplene in treating AML patients in Europe. As an outcome of that meeting, SAB members have committed to help facilitate physician access to and use of Ceplene in AML and hematologic disease.

EpiCept had a commercial presence at both the European Hematology Association earlier this year and at the American Society of Hematology meeting in December. The company intends to continue and expand upon these efforts in 2010 in conjunction with a European partner, as appropriate, to facilitate the commercial launch of Ceplene.

“We believe that positive results from either the trial of Ceplene in MDS with Vidaza or Ceplene in CML with Gleevec would indicate a potentially significant public health benefit from the use of Ceplene in combination with these currently marketed drugs, and provide an important pathway for expanding the label for Ceplene and its future market potential,” remarked Jack Talley, President and Chief Executive Officer of EpiCept. “These trials, along with the efforts of our SAB, are increasing Ceplene’s exposure to physicians in Europe and educating them on its proper use and administration. We believe these efforts will provide significant rewards for EpiCept in the future as we work towards finalizing a commercial partnership agreement for this life-saving medicine.”