AML Drug Candidate Granted Breakthrough Therapy Designation
GlycoMimetics announced that its candidate treatment GMI-1271, for adults with relapsed/refractory acute myeloid leukemia (AML), has been granted Breakthrough Therapy designation.
GMI-1271, a small molecule E-selectin antagonist, was previously granted Orphan Drug designation and Fast Track status by the Food and Drug Administration (FDA). Blocking E-selectin may also protect normal blood-producing cells as well as reduce the toxicity of chemotherapy (eg, neutropenia).
Data from an ongoing multicenter, open-label Phase 1/2 trial was presented at the American Society of Hematology in 2016 that evaluated GMI-1271 as adjunct to chemotherapy to patients with relapsed/refractory AML in addition to patients aged ≥60 years with newly diagnosed disease. The study data demonstrated that patients in the GMI-1271 arm achieved higher than expected remission rates and lower than expected 30- and 60-day mortality rates in early evaluations.
Enrollment for the first 2 patient cohorts in the Phase 2 part of the trial was completed in March. GMI-1271 is also being evaluated for the treatment of multiple myeloma.
For more information call (240) 243-1201 or visit Glycomimetics.com.