EpiCept Corporation (EPCT) was dealt a body blow by the US Food and Drug Administration (FDA) recently with the agency rejecting the company’s new drug application (NDA) for its lead candidate Ceplene (histamine dihydrochloride).
The application sought approval for marketing Ceplene as a combination therapy with the anti-cancer agent interleukin-2 (IL-2) for remission and prevention of recurrence in patients suffering from acute myeloid leukemia (AML).
We note that Ceplene was approved for a similar indication in the European Union in 2008 and is administered with a mild dose of IL-2. However, the FDA, while rejecting the NDA, questioned the efficacy of the AML candidate. The US regulatory body has asked the company to conduct an additional study to confirm Ceplene’s effectiveness. Following the receipt of the letter rejecting the NDA, EpiCept intends to discuss its regulatory options with the agency.
EpiCept, founded in 1993 and based in Tarrytown, New York, also has two other oncology candidates in its pipeline. The candidates have demonstrated the ability to act as vascular disruption agents in a variety of solid tumors in clinical trials. The company also targets the pain market with its pain portfolio including EpiCept NP-1, a topical analgesic cream which is in its late-stage development. The cream is being developed to provide long-term relief from pain arising from peripheral neuropathies. Even though the pipeline at EpiCept is diverse, we believe that it must deliver in order to sustain growth.