Biosight Granted U.S. FDA Fast Track Designation for BST-236
Biosight Granted U.S. FDA Fast Track Designation for BST-236 for the Treatment of Acute Myeloid Leukemia
Aug. 04, 2020
Biosight Ltd., a pharmaceutical development company developing innovative therapeutics for hematological malignancies and disorders, today announced that that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for BST-236 (aspacytarabine) for the treatment of acute myeloid leukemia (AML) in adults who are 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy. BST-236, Biosight’s lead product candidate, is a novel antimetabolite, designed to provide the benefit of intensive chemotherapy while avoiding much of its toxicity. The company is currently enrolling patients in its Phase 2b study, evaluating BST-236 as a single-agent first-line AML therapy for patients unfit for standard chemotherapy, and recently announced a collaboration with the European cooperative group, GFM, for the initiation of a phase 2 trial of BST-236 in relapsed/refractory myelodysplastic syndrome (MDS) and AML patients, to begin in the fourth quarter of 2020.