BioLineRx reports progress for Phase 3 Genesis trial
BioLineRx Ltd. (BLRX) reported that it has achieved the enrollment target for its Phase 3 trial GENESIS to enable an interim efficacy analysis. The company stated that the analysis will likely take place during the second half of 2020. The study is assessing the potential of motixafortide (BL-8040) for the mobilization of hematopoietic stem cells.
BioLineRx stated that it may decide to cease further recruitment, should the primary endpoint be met at the time of the interim analysis. However, the company will continue the recruitment if the primary endpoint is not met in the interim analysis. Philip Serlin, Chief Executive Officer of BioLineRx, said, “A significantly lower than anticipated patient dropout rate in the GENESIS trial triggered our decision to conduct an interim efficacy analysis, for which we have now enrolled a sufficient number of patients.”
GENESIS is a randomized, placebo-controlled, multicenter study. It is designed to assess the safety, tolerability and efficacy of motixafortide and G-CSF, compared to placebo and G-CSF, for mobilizing HSCs for autologous transplantation in multiple myeloma patients. The primary endpoint of the study is to show that motixafortide on top of G-CSF is superior to G-CSF alone in the ability of mobilize ≥ 6x106 CD34+ cells in up to two apheresis sessions. The secondary objectives include time to engraftment of neutrophils and platelets, durability of engraftment and other efficacy and safety metrics.
BioLineRx is mainly invested in developing therapies for different oncological ailments. Motixafortide is the company’s lead program and is a part of a Phase 2a study for treating pancreatic cancer. It is also working on an immunotherapy treatment program for multiple solid tumors named AGI-134.
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