Ceplene receives OD status in Europe for AML
Maxim Pharmaceuticals' Ceplene (histamine dihydrochloride) has been granted orphan drug designation by the European Commission for the treatment of acute myeloid leukaemia patients.
Maxim Pharmaceuticals' Ceplene (histamine dihydrochloride) has been granted orphan drug designation by the European Commission for the treatment of acute myeloid leukaemia patients.
This is following adoption of a positive opinion by the Committee for Orphan Medicinal Products of the European Agency for the Evaluation of Medicinal Products. Orphan drug status is granted by the EC to promote development of drugs to treat rare diseases or conditions. Orphan drug designation in the EU may provide several benefits, including 10 years marketing exclusivity throughout Europe for the therapeutic indication for which it was granted, facilitated access to the Centralised Procedure for the application for marketing approval, reduced fees associated with applying for marketing approval and protocol assistance, and access to EU research funding grants.
'The granting of orphan drug status of Ceplene for the treatment of acute myeloid leukemia patients in complete remission recognises the need for new therapeutic options. This is a positive event for our efforts to seek a partner to continue Ceplene development in Europe and the United States,' commented Larry Stambaugh, president and chief executive officer of Maxim.
Maxim has completed a Phase 3 study of Ceplene + IL-2 (Proleukin) in patients with acute myeloid leukaemia in which the treatment group met the primary endpoint of the trial, leukaemia-free survival (LFS) when compared with the standard of care (no treatment) for patients in first or subsequent remission in an intent-to-treat analysis. The treatment group had a significantly better LFS than the control group (P = 0.00964), based on a stratified log-rank test.
About AML
AML is the most common form of acute leukaemia in adults. There are approximately 11,900 new cases of AML and 8,900 deaths caused by this cancer each year in the United States, with similar incidence and mortality rates in Europe. Prospects for long-term survival are poor for the majority of AML patients. Once diagnosed with AML, patients are typically treated with chemotherapy. Although approximately 75% of patients achieve a complete remission, median time in remission before relapse is only 12 months, and only 20% of patients will survive five years or more. There are currently no accepted remission maintenance therapies for AML patients. Ceplene also has orphan drug status from the FDA for the treatment of AML.