EpiCept's phase 3 study of Ceplene in AML meets endpoint of increased leukemia-free survival

By Lisa Kerner

Erie, Pa., March 31 - EpiCept Corp. said its randomized, multi-center phase 3 clinical study of Ceplene in the treatment of advanced myeloid leukemia (AML) met its primary endpoint of increased leukemia-free survival among AML patients in remission at three years.

The results of the study were published online in Blood, a scientific journal in hematology, on March 24. The article is entitled "Improved Leukemia-Free Survival After Post-Consolidation Immunotherapy with Histamine Dihydrochloride and Interleukin-2 in Acute Myeloid Leukemia."

The study of 320 patients was conducted in 11 countries.

Patients with AML in complete remission who received 18 months of treatment with Ceplene (histamine dihydrochloride) plus low-dose interleukin-2 (IL-2) experienced a significantly improved leukemia-free survival compared to the current standard of care, according to a company news release.

Common Ceplene side effects included injection site reactions, fever and fatigue, with no treatment-related mortality observed, the company said.

While AML patients typically receive intensive treatment with chemotherapeutic drugs at diagnosis and become free of detectable leukemia, the majority of patients will experience relapse within one to two years.

"The high rate of relapse of leukemia in AML patients is a major clinical challenge," study chairman Mats Brune said in the release.

"It is gratifying that treatment with Ceplene/IL-2 appears to be associated with improved long-term leukemia-free survival."

AML is the most common form of acute leukemia in adults, with about 11,900 new cases of AML and 8,900 deaths caused by this cancer each year in the United States.

Based on the findings of this study, EpiCept said it plans to file a Market Authorization Application with the European Agency for the Evaluation of Medicinal Products for approval of Ceplene in Europe in 2006 as remission maintenance therapy for patients with AML.

EpiCept, based in Englewood Cliffs, N.J., is an emerging pharmaceutical company focused on unmet needs in the treatment of pain and cancer.

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