- The European Medicines Agency designates Stemline Therapeutics' (NASDAQ:STML +8.6%) SL-401 an Orphan Drug for the treatment of acute myeloid leukemia (AML). Among the benefits of the status is a 10-year period of market exclusivity for the indication, if approved.
- SL-401 is a recombinant fusion protein composed of certain domains of the diptheria toxin fused to interleukin 3 (IL3). SL-401 is described as "targeted" because the IL3 seeks out IL3 receptors on cancer stem cells (CSCs), the malignant "seeds" of tumors, and tumor bulk of blood cancers. Binding to the receptors delivers the cytoxin directly to the cancer cells.
- SL-401 is currently being investigated in three clinical trials across seven indications.