- BioLineRx BLRX has announced positive top-line results from GENESIS Phase 3 trial evaluating its lead clinical candidate, Motixafortide, combined with granulocyte colony-stimulating factor (G-CSF), for hematopoietic stem-cell mobilization for autologous bone marrow transplantation in multiple myeloma patients.
- An analysis of data on all 122 enrolled patients found highly statistically significant evidence across all primary and secondary endpoints favoring Motixafortide in addition to G-CSF, as compared to placebo plus G-CSF.
- The primary endpoint of the study demonstrated a 4.9-fold increase (70.0% vs. 14.3%; difference 54.6%) in the proportion of patients in the treatment arm, as compared to the control arm, mobilizing over 6 million CD34+ cells/kg in up to two apheresis sessions and after only one administration of Motixafortide.
- The study also achieved its secondary endpoint, demonstrating a 14.1-fold increase (67.5% vs. 4.8%; difference 61.7%) in the proportion of patients in the treatment arm, as compared to the control arm, which mobilized over 6 million CD34+ cells/kg in just one apheresis session.
- A 5.6 fold increase was observed in the median number of CD34+ cells collected on the first day of apheresis (8.5 million in the treatment arm vs. 1.5 million in the control arm).
- The addition of Motixafortide to G-CSF also allowed 88.3% of patients to undergo transplantation after only one apheresis session, compared to 10.8% in the G-CSF arm.
- BioLineRx will hold a conference call today at 10:00 a.m. ET.
- Price Action: BLRX shares are up 75.9% at $5.62 in the premarket session on the last check Tuesday.
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