BioLineRx Phase 2b AML

BioLineRx Ltd. (NASDAQ: BLRX; TASE: BLRX), is about to start a Phase 2b trial for BL-8040 as a novel consolidation treatment for acute myeloid leukemia (AML). The Phase 2b study will examine its ability to improve outcomes for AML patients who have achieved remission after standard treatment by eliminating the minimal residual disease left in the bone marrow that can lead to relapse, known as consolidation therapy. The study is expected to commence shortly after the receipt of regulatory approval, which is anticipated in the next few months, and is the first of three additional planned clinical studies that significantly expand BioLineRx’s unique BL-8040 platform for treating hematological cancers.

The Phase 2b trial is a double-blind, placebo-controlled, randomized, multi-center study conducted in collaboration with the University of Halle as sponsor and with the participation of two large leukemia study groups in Germany. Regulatory submissions with BfArM, the German Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte) and the relevant ethics committees have been made.