TEL AVIV, Israel, May 3, 2017 /PRNewswire/ --

- Initiation of Phase 3 registrational study expected in second half of this year 

- Study to focus on stem cell mobilization for autologous transplantation in multiple myeloma patients

BioLineRx Ltd. (NASDAQ/TASE: BLRX, BLRX.TA), a clinical-stage biopharmaceutical company focused on oncology and immunology, today announced that it has met with the U.S. Food and Drug Administration (FDA) and has gained clarity on the development program and the design of a Phase 3 pivotal study for BL-8040, its robust platform for multiple oncology indications, as a novel stem cell mobilization treatment for autologous bone-marrow transplantation. Following its successful 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," said Philip Serlin, Chief Executive Officer of BioLineRx. "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."

"We see clear potential for BL-8040 to benefit multiple myeloma patients undergoing autologous bone marrow transplantation. In parallel, we are continuing to expand the potential of our unique BL-8040 oncology platform, with multiple clinical studies for additional indications that are up and running or expected to commence during 2017. These include several combination studies with immune checkpoint inhibitors, a Phase 2b study in consolidation AML and a Phase 2 study in allogeneic stem-cell mobilization as a monotherapy with topline results expected by the end of 2017," added Mr. Serlin.

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