EpiCept shares hammered as FDA calls for additional study on AML drug candidate Ceplene

24 August 2010

Tarrytown, NY, USA-based drug developer EpiCept (Nasdaq; EPCT) took a battering in morning trading yesterday, after the company revealed that it had received a refusal to file letter from the US Food and Drug Administration relating to its New Drug Application for Ceplene (histamine dihydrochloride), seeing its share price plummet 43% to $0.62.

Ceplene, which the firm acquired along with its $136 million acquisition of Maxim in 2006, is EpiCept's novel therapeutic candidate for the remission maintenance and prevention of relapse of patients with acute myeloid leukemia (AML) in first remission, which was approved in the European Union in 2008 and is co-administered with low-dose interleukin-2 (IL-2).

In its preliminary review of the Ceplene NDA, the FDA concluded that the application did not establish the drug's therapeutic contribution in its combination with IL-2, and recommended that an additional confirmatory pivotal trial assessing Ceplene's contribution and using
overall survival as a primary endpoint be conducted.

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