BioLineRx says 'extremely encouraged' by lead-in period of Phase 3 GENESIS trial
BioLineRx announced results from the lead-in period of the GENESIS trial, a double-blind, placebo-controlled Phase 3 trial comparing BL-8040 in combination with granulocyte colony-stimulating factor, to G-CSF alone, for the mobilization of hematopoietic stem cells used for autologous transplantation in multiple myeloma patients. The open-label, single-arm, lead-in period of the study was designed to include up to 30 patients, with Data Monitoring Committee review after completion of approximately 10, 20 and 30 patients, in order to assess safety and efficacy following treatment with BL-8040 plus G-CSF. Results of the first 11 patients show that BL-8040 in combination with standard G-CSF treatment is safe and tolerable. In addition, the data show that 9/11 patients reached the primary endpoint threshold of greater than or equal to 6x106 CD34 cells/kg with only one dose of BL-8040 and in up to 2 apheresis sessions. Furthermore, 7/11 patients reached the threshold of greater than or equal to 6x106 CD34 cells/kg in a single apheresis session only. These data demonstrate the potential of BL-8040 treatment to reduce the number of administrations and apheresis sessions, as well as hospitalization costs, related to the preparation of multiple myeloma patients for autologous HSC transplantation. "We are extremely encouraged by these results. Based on the robust data received from the first 11 patients, the DMC issued a positive recommendation to stop the lead-in part of the study and move immediately to the randomized placebo-controlled part of the study. This is the first Phase 3 trial for our lead BL-8040 program, and as such, it is an important milestone in BL-8040's comprehensive development plan. We look forward to the top-line results from the randomized, double-blind, placebo-controlled part of the study, which are expected in 2020," stated Philip Serlin, Chief Executive Officer of BioLineRx.