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The EMA grants GMI-1271 Orphan Drug Designation for AML
On 25th May 2017, the European Medicines Agency’s (EMAs) Committee for Orphan Medicinal Products (COMP) granted Orphan Drug Designation for GMI-1271, a novel E-selectin (E-sel) antagonist , for the treatment of patients with Acute Myeloid Leukemia (AML).1 This comes after GMI-1271 was granted an orphan drug designation for the treatment of Relapsed or Refractory (R/R) AML by the U.S. Food and Drug Administration (FDA) earlier this month.
GMI-1271 is a novel antagonist of E-sel, (a cell adhesion molecule that contributes to leukemic cell survival pathways) and acts by disrupting leukemia cell survival pathways thus enhancing chemotherapy response.2,3
GMI-1271 is currently being investigated in the phase 2 portion of the phase 1/2 study (NCT02306291), which is aiming to assess the safety, efficacy and pharmacokinetics of this agent in combination with standard chemotherapy in patients with R/R AML and also in AML patients 60 years of age and older with newly diagnosed disease. Results from this study will be presented during this year’s American Society of Clinical Oncology Annual Meeting, taking place in Chicago between 2nd–6th June and also at the European Hematology Association (EHA) congress taking place in Madrid between 22nd–26th June.
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