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news.EpiCept has requested market authorization from the European Medicines Agency for Ceplene, the company's lead oncology product candidate.
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Ceplene is to be administered in conjunction with interleukin-2 (IL-2), for the maintenance of first remission in patients with acute myeloid leukemia (AML).
The European Commission has previously granted orphan drug status to Ceplene for use in the treatment of AML.
The efficacy and safety data for this submission is from a phase III clinical trial for Ceplene in conjunction with interleukin-2. This study met its primary endpoint of preventing relapse as shown by increased leukemia-free survival for AML patients in remission. Patients in their first remission had a 55% improvement in leukemia free survival.
“There is a distinctive need for new treatment options to improve long-term leukemia free survival among AML patients. The majority of AML patients in complete remission will experience a relapse of leukemia with a progressively poor prognosis,” remarked Professor Kristoffer Hellstrand, Sahlgrenska University Hospital, Sweden.
EpiCept also commented that they would be seeking a partner to help them market and sell Ceplene in Europe. EpiCept retains full marketing rights for Ceplene worldwide.