Maxim Pharmaceuticals' Ceplene (histamine dihydrochloride) was granted orphan drug designation by the European Commission for the treatment of acute myeloid leukaemia patients following adoption of a positive opinion by the Committee for Orphan Medicinal Products of the European Agency for the Evaluation of Medicinal Products.

"The granting of orphan drug status of Ceplene for the treatment of acute myeloid leukaemia patients in complete remission recognizes 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 G. Stambaugh, president and CEO 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 to 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.

Ceplene is based on the naturally occurring molecule histamine, and is designed to prevent or inhibit oxidative stress, protecting critical immune cells. Research has demonstrated that oxidative stress suppresses the immune system's ability to destroy virally infected cells and cancer cells.