EpiCept requests FDA priority review of Ceplene NDA for AML

January 27, 2016

The NDA submission is supported by a robust body of evidence demonstrating a significant clinical benefit of Ceplene/IL-2 for remission maintenance in AML as compared with the standard-of-care, which is no treatment. The pivotal Phase III study was conducted in ten countries and included 320 randomized patients. The data demonstrated that patients with AML in complete remission who received up to 18 months of treatment with Ceplene plus low-dose IL-2 experienced a significantly longer period of leukemia-free survival (LFS) compared to the standard-of-care. The difference between the treated and control group was statistically significant (p<0.008). Ceplene is the only medical therapy shown to extend LFS in this deadly form of leukemia.

At the request of the FDA, EpiCept has included in its NDA the results of two meta-analyses to help isolate Ceplene's efficacy. The first analysis confirmed the lack of clinical efficacy of IL-2 monotherapy as remission maintenance for AML patients and the second demonstrated the contribution of Ceplene in this indication when given in conjunction with IL-2. These two meta-analyses were conducted by independent statisticians and support the conclusions of the pivotal Phase III trial.

If priority review is not granted, the FDA has up to 60 days to accept the filing for review and assign an FDA decision date. In addition to the NDA filing in the U.S., a New Drug Submission for Ceplene is currently under active review by Health Canada, which is expected to complete its review and provide a decision by the fourth quarter of 2010. Ceplene is also under review by the Israeli Ministry of Health. As noted earlier, Ceplene is approved in thirty countries in Europe.

SOURCE EpiCept Corporation