EpiCept Corporation has released new long-term data showing that the use of Ceplene when administered in conjunction with low-dose interleukin-2 (IL-2) provides durable protection from leukaemia relapse in patients with Acute Myeloid Leukaemia (AML), based on a minimum of six years of follow-up.

The presentation entitled 'Six-Year Outcomes Update from a Randomized Phase 3 Trial in AML: Durable Effect of Remission Maintenance Immunotheraphy with Histamine Dihydrochloride and low-dose IL-2' was authored by Dr Mats Brune, and co-workers.

Researchers analyzed follow-up data from patients enrolled in the phase-III pivotal trial of Ceplene. The primary endpoint assesses the durability of the benefit of Ceplene with IL-2 in achieving leukaemia-free-survival (LFS), after a minimum of six years, in patients who have achieved first complete remission (CR1) and among the overall patient group. The study found that the Ceplene/IL-2 treatment group continued to show statistically significant differences in LFS in the overall treatment population (p=0.011) and among the CR1 group (p=0.015).

"These data provide further demonstration of the positive and prolonged clinical benefits Ceplene can provide AML patients in preventing relapse of this deadly disease," remarked Jack Talley, president and CEO of EpiCept. "These findings also represent the latest in a number of significant milestones for Ceplene, as we just announced that the drug is now available to patients in major markets throughout the world through our named patient program agreement with IDIS. We continue to be keenly focused on further expanding the extraordinary impact that Ceplene can have on AML patients through our regulatory advancement of the drug in North America."

Ceplene is EpiCept's proprietary product approved in the European Union for maintenance therapy for adult patients with AML in first remission. Ceplene is designed to protect lymphocytes responsible for immune-mediated destruction of residual leukaemia cells.

EpiCept is focused on the development and commercialization of pharmaceutical products for the treatment of cancer and pain.