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The FDA grants GMI-1271 Breakthrough Therapy Designation for the treatment of R/R AML
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On 17th March 2017, the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation to GMI-1271, a novel E-selectin (E-sel) antagonist , for the treatment of patients with Relapsed or Refractory (R/R) Acute Myeloid Leukemia (AML).1
E-sel is a cell adhesion molecule expressed constitutively in the bone marrow endothelium and it is involved in cell signaling and chemotaxis. Binding of AML blasts to E-selectin (E-sel), can lead to activation of leukemic cell survival pathways, thereby contributing to chemotherapy resistance. GMI-1271 is a novel antagonist of E-sel, which acts by disrupting leukemia cell survival pathways thus enhancing chemotherapy response.2,3
Currently, GMI-1271 is being explored 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.
- GlycoMimetics: GMI-1271 Receives FDA Breakthrough Therapy Designation for Adult Relapsed/Refractory Acute Myeloid Leukemia. 2017 May 17.http://ir.glycomimetics.com/releasedetail.cfm?ReleaseID=1026865 [Accessed 2017 May 18].
- National Cancer Institute: E-selectin antagonist GMI-1271. https://www.cancer.gov/publications/dictionaries/cancer-drug?cdrid=767121. [Accessed 2017 May 18].
- DeAngelo D. J. et al. A Phase I/II Study of GMI-1271, a Novel E-Selectin Antagonist, in Combination with Induction Chemotherapy in Relapsed/Refractory and Elderly Previously Untreated Acute Myeloid Leukemia; Results to Date. 2016 Dec 5. Abstract 2029. 58th Annual Meeting of the American Society of Hematology, San Diego, Ca.
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