BioLineRx Initiates Phase 2b Trial In Acute Myeloid Leukemia

(RTTNews) - Clinical-stage biopharmaceutical company BioLineRx Ltd. (BLRX) Monday announced the initiation of a Phase 2b trial for BL-8040 for the treatment for acute myeloid leukemia or AML. The study will examine BL-8040 to improve outcomes for AML patients, with remission after the standard initial treatment regimen.

The company said the trial will study about the minimal residual disease left in the bone marrow after induction therapy that probably lead to the relapse. The study will enroll up to 194 patients of 18 to 75 years of age at 25 sites in Germany.

Dr. Kinneret Savitsky, Chief Executive Officer of BioLineRx, said, BL-8040 is anticipated to boost the efficacy of consolidation therapy due to its dual mechanism of action. It can induces mobilization of leukemic cells from the bone marrow, which enhances the cytotoxic effects of chemotherapy, and secondly, it possesses anti-leukemic pro-apoptotic properties that help eliminate AML cells directly.

The double-blind, placebo-controlled, randomized, multi-center study is conducted in collaboration with the University of Halle and with the participation of two large leukemia study groups in Germany. The primary endpoint of the study is to compare the relapse free survival time in AML subjects in their first remission during a minimum follow-up time of 18 months after randomization.