Study: IL-2 monotherapy not effective as maintenance therapy for acute myeloid leukemia

“Individual patient data meta-analysis of randomized trials evaluating IL-2 monotherapy as remission maintenance therapy in acute myeloid leukemia”

EpiCept Corporation (Nasdaq and Nasdaq OMX Stockholm Exchange: EPCT) announced today the publication of a new meta-analysis which concluded that interleukin-2 (IL-2) monotherapy is not effective as a maintenance therapy for acute myeloid leukemia (AML) patients in first complete remission. These results were published in the July 7, 2011 edition of Blood, a leading scientific journal in hematology.

The analysis appears in an article entitled "Individual patient data meta-analysis of randomized trials evaluating IL-2 monotherapy as remission maintenance therapy in acute myeloid leukemia," and was designed to determine the efficacy of IL-2 monotherapy by combining all available individual patient data from five randomized clinical trials and summary data from a sixth trial. The combined individual patient data of 1,455 patients collected over several years showed no benefit of IL-2 compared with standard of care in terms of leukemia free survival (LFS).

The authors highlight the view that the efficacy of IL-2 monotherapy could be hampered by the activity of other immune cells. Several preclinical studies have established a role for Ceplene^® (histamine dihydrochloride) to protect the viability and function of anti-leukemic lymphocytes. A Phase III randomized trial of AML patients in complete remission with Ceplene^®/IL-2 combination therapy resulted in a significant prolongation of LFS (p<0.01) and a trend towards improvement in OS>®.

The findings of this meta-analysis provide further evidence of the pivotal role that Ceplene^® plays in prolonging LFS in AML patients in first remission when used in conjunction with low-dose IL-2.

Jack Talley, EpiCept President and CEO, commented, "The conclusion of this meta-analysis validates our approach that Ceplene^® in combination with IL-2 is effective in remission maintenance therapy. Our clinical trial is the only remission maintenance trial to show a clear benefit in prolonging LFS in AML patients. Further, this new analysis also supports our position, endorsed by the European Medicines Agency, that because IL-2 monotherapy treatment has been shown to be ineffective, it is now unethical to offer that therapy in any subsequent clinical study."

EpiCept is seeking a follow-up meeting with the U.S. Food and Drug Administration (FDA) to discuss the FDA's responses to the Company's application for a Special Protocol Assessment for Ceplene^® including the FDA's initial comments on the protocol in favor of an IL-2 monotherapy arm.