BioLineRx, a clinical-stage biopharmaceutical company focused on oncology and immunology, announced the filing of regulatory submissions required to commence a randomized, controlled phase III registrational trial of BL-8040 for the mobilization of hematopoietic stem cells for autologous transplantation in patients with multiple myeloma. The trial, named GENESIS, is expected to commence by the end of 2017, following receipt of regulatory approvals.
The phase III GENESIS trial is aimed at evaluating the safety, tolerability and efficacy of the combination treatment of BL-8040 and granulocyte colony-stimulating factor (G-CSF), as compared to the control arm of placebo and G-CSF. The trial will be conducted in two parts: The first part, designed to validate the optimal dosing of BL-8040, is a lead-in, open-label, multi-center study that will include 10-30 patients, in order to assess the efficacy and safety of treatment with BL-8040 and G-CSF. This part will be followed by a randomized, placebo-controlled, multi-center study in approximately 180 patients. The primary endpoint will be the proportion of subjects mobilizing 6.0 x 106 CD34+ cells/kg with up to two apheresis sessions in preparation for autologous transplantation after a single administration of BL-8040 and G-CSF, as compared to placebo and G-CSF.
Philip Serlin, Chief Executive Officer of BioLineRx, stated, "We are excited to move forward with BL-8040 into a phase III registration study. We have previously reported positive results supporting BL-8040 as a one-day dosing and up-to-two-day collection regimen for rapid mobilization of stem cells. This represents a significant improvement over the current treatment, which requires four-to-eight daily injections of G-CSF and one-to-four apheresis sessions. We therefore hope that this phase III trial will further support these results and help improve the standard of care for multiple myeloma patients."
"In parallel, we are continuing to expand the potential of our robust BL-8040 oncology platform, by advancing multiple clinical studies for additional indications that are ongoing or expected to commence during 2017. These include a large, randomized, controlled phase IIb study in AML, as well as several phase II combination studies with immune checkpoint inhibitors in solid tumors and hematological malignancies," added Serlin.