EpiCept's MAA submission for Ceplene is being assessed under the EU centralized procedure, and if approved, will provide a marketing authorization valid in all EU member states, along with Iceland, Liechtenstein and Norway. The European Commission has previously granted orphan drug status to Ceplene for use in the treatment of AML. If the application for Ceplene continues to follow usual EU regulatory timelines, the next milestone on Ceplene's path to approval is expected to be the CHMP Day 180 list of outstanding issues, which EpiCept expects will be received in the fourth quarter of 2007. EpiCept expects this to be followed by a recommendation regarding approvability from the CHMP and a final decision by the European Commission during the first half of 2008.
Ceplene is EpiCept's registration-stage compound for the treatment of AML. Ceplene is designed to protect lymphocytes responsible for immune-mediated destruction of residual leukemic cells. Laboratory research has demonstrated that Ceplene reduces formation of oxygen radicals from phagocytes, inhibiting NADPH oxidase and protecting IL-2-activated NK-cells and T-cells.
About Acute Myeloid Leukemia (AML)
AML is the most common form of acute leukemia in adults. There are
approximately 47,000 AML patients in the EU, with 14,000 new cases
occurring each year. For the majority of AML patients, the prospects for
long-term survival are disappointing. Once diagnosed with AML, patients are
treated with toxic chemotherapies. Although approximately 75% of patients
achieve a complete remission, the leukemia frequently recurs (a "relapse"),
usually within 1-2 years. Despite follow-up treatment that may include very
toxic chemotherapy or bone marrow transplantation, only 10% to 20% of
patients survive l
|SOURCE EpiCept Corporation|
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