ARTICLE | Clinical News

BioSight reports Phase I/II data for AML candidate

January 5, 2018 10:20 PM UTC

BioSight Ltd. (Airport City, Israel) reported final data from 14 evaluable patients with newly diagnosed acute myelogenous leukemia (AML) in the Phase I/II BSTPHASE1-01 trial showing that BST-236 (astarabine) led to a median overall survival (OS) of 6.5 months and a 1-year survival rate of 27%. In 11 patients with de novo AML or AML secondary to myelodysplastic syndrome (MDS), 36% achieved a durable complete remission (CR). BioSight said BST-236 was well tolerated at doses up to 6 g/m2 per day for six days. Data were presented at the American Society of Hematology meeting in Atlanta.

The open-label, Israeli trial enrolled 26 patients with relapsed or refractory AML, newly diagnosed AML or acute lymphoblastic leukemia (ALL). The primary endpoints were maximum tolerated dose (MTD) and dose-limiting toxicities (DLTs). Secondary endpoints include safety, pharmacokinetics and overall response rate (ORR)...