BioLineRx Receives Approval to Commence Phase 1 Trial for Novel Stem Cell Mobilization Treatment

Biopharmaceutical company BioLineRx received approval to commence Phase 1 Trial for novel stem cell mobilization of stem cells from the bone marrow to the peripheral blood circulation. Stem cell mobilization is a way to collect stem cells from bone marrow without surgical manipulations for autologous use or donation.

The Phase 1 study consists of two parts. Part 1 is a randomized, double-blind, placebo-controlled dose escalation study exploring the safety and tolerability of escalating repeated doses of BL-8040 in healthy volunteers. Part 1 serves to establish the dose for Part 2 of this trial. Part 2 is an open-label study designed to assess BL-8040’s stem cell mobilization capacity, as well as the yield of cells collected by apheresis.

Phase 1 trial of BL-8040 is expected to begin in Q3 2014, results are expected in late 2014 or early 2015

BL-8040 is a clinical-stage drug candidate for the treatment of acute myeloid leukemia, as well as other hematological indications.  It is a short peptide,  antagonist for a chemokine receptor that is directly involved in tumor progression, angiogenesis and cell survival. BL-8040 mobilizes cancer and stem cells from the bone marrow. BL-8040 was licensed by BioLineRx from Biokine Therapeutics and was previously developed under the name BKT-140.