BioLineRx reports Phase 2 results on BL-8040 for stem cell mobilization
BioLineRx announced "positive" results from a Phase 2 clinical trial assessing BL-8040 as a single agent for hematopoietic stem cell mobilization in an allogeneic transplantation setting. Mobilization of hematopoietic stem and progenitor cells for the purpose of donor transplantation after high-dose chemotherapy is currently performed using a 4-5 day treatment cycle with G-CSF and a 1-2 day apheresis procedure. Single-agent treatment with BL-8040, a novel, high-affinity CXCR4 antagonist with rapid HSPC mobilizing kinetics, showed similar efficacy in only one administration. In addition, BL-8040 showed non-inferiority in recipient engraftment, with all transplanted recipients successfully engrafting with BL-8040-mobilized grafts. Of the 21 evaluable donors that have been enrolled in the study to date, 11 out of 13 donors, 85%, treated at the 1 mg/kg dose and 8/8 donors, 100%, treated at the 1.25 mg/kg dose of BL-8040 reached the primary goal of greater than or equal to2x106 CD34 cells/kg of recipient weight in up to 2 leukapheresis sessions. BL-8040 was safe and well tolerated. 13 transplanted recipients have reached the secondary endpoint of 100 days post-transplant. Results of the lead-in period from the Phase 3 trial are expected in the next few months.