BioLineRx announced it met with the U.S. Food and Drug Administration (FDA) and gained clarity on the development program and the design of a Phase 3 pivotal study for BL-8040 as a novel stem cell mobilization treatment for autologous bone-marrow transplantation. Following its meeting with the FDA, the company anticipates the initiation of a registrational Phase 3 trial during the second half of 2017. The study will investigate BL-8040 in combination with granulocyte colony-stimulating factor (G-CSF) for mobilization of stem cells from the bone marrow to the peripheral blood, followed by collection and subsequent autologous transplantation in patients with multiple myeloma.

"BL-8040 given as a single injection in a Phase 1/2 study in multiple myeloma patients was previously shown to be highly effective in mobilizing stem cells in combination with G-CSF," Philip Serlin, Chief Executive Officer of BioLineRx said. "Following our recent successful meeting with the FDA, we believe we have a clear development path forward towards registration of BL-8040 as a novel stem cell mobilization treatment for autologous transplantation. We look forward to the initiation of the Phase 3 pivotal study later this year, which, if successful, could pave the way for future commercialization of BL-8040."

BL-8040 is a short peptide for the treatment of acute myeloid leukemia, solid tumors, and stem cell mobilization. It functions as a high-affinity antagonist for CXCR4, a chemokine receptor that is directly involved in tumor progression, angiogenesis, metastasis and cell survival. CXCR4 is over-expressed in more than 70% of human cancers and its expression often correlates with disease severity.