EpiCept Corporation (Nasdaq and Nasdaq OMX Stockholm Exchange: EPCT) today announced the Company has identified a statistically significant survival benefit in a subgroup of Acute Myeloid Leukemia (AML) patients in its previous Phase III trial with Ceplene® (histamine dihydrochloride) administered with low-dose interleukin-2 (IL-2). The identification of this subgroup is expected to influence the design of the protocol for a new Phase III trial to support resubmission of a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA). Ceplene® is approved in the European Union and Israel for the remission maintenance and prevention of relapse in adult patients with AML in first remission.
In October 2010 EpiCept reached an agreement with the FDA on a regulatory path for a resubmission of the Ceplene® NDA. Under the agreement, EpiCept intends to undertake a new confirmatory clinical trial to demonstrate Ceplene®'s benefit with overall survival as the primary endpoint.
As part of its clinical trial protocol preparations for the Ceplene® pivotal study, EpiCept conducted an additional analysis of AML subgroups from its previous Phase III study of Ceplene®. While that study was not powered to determine overall survival, EpiCept's analysis has identified that patients with AML of monocyte origin achieved a statistically significant increase in overall survival after treatment with Ceplene® plus low-dose IL-2. Furthermore, this analysis identified a strong correlation between the administration of high-intensity consolidation treatment, and improvements in overall survival.
EpiCept has applied these findings in the development of the clinical trial protocol and is currently reviewing the protocol with key opinion leaders in hematology. The Company expects to submit this protocol to the FDA in the second quarter of 2011, following which the FDA, via the Special Protocol Assessment procedure, will provide guidance on specific sections of the protocol. Based on this anticipated schedule, EpiCept expects to initiate the trial in the second half of 2011.
EpiCept also announced that it has submitted additional U.S. and global patent applications based on the discoveries of the efficacy of Ceplene® plus IL-2 in AML of monocyte origin. The Company believes that these provisional patents, if granted, would provide an additional 20 years of market exclusivity for Ceplene® from the date of patent filing.
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