Based on the findings of this study, the company plans to file a market authorization application (MAA) with the European Agency for the Evaluation of Medicinal Products (EMEA) for approval of Ceplene (histamine dihydrochloride) in Europe in 2006 as remission maintenance therapy for patients with advanced myeloid leukemia (AML).
After being diagnosed with AML, patients receive intensive treatment with chemotherapeutic drugs, and typically become free of detectable leukemia (“complete remission”). However, the majority of patients will experience relapse of leukemia, usually within 1-2 years. The survival prognosis after a leukemic relapse is poor.
The study was conducted in eleven countries. The results, which were published in hematology journal Blood, showed that patients with AML in complete remission who received 18 months of treatment with Ceplene plus low-dose interleukin-2 (IL-2) experienced a significantly improved leukemia-free survival compared to the current standard of care.
“There is an urgent need for new therapeutic options for patients suffering from AML,” said Professor Kristoffer Hellstrand, of the Sahlgrenska University Hospital in Goteborg, Sweden, and an author of the study. “These data indicate that treatment with Ceplene/IL-2 offers an efficacious and tolerable option for AML patients in remission.”