Company: BLRX
Filing Date: 2025-03-31
Form Type: 20-F
Source: 0001178913-25-001123
Chunk: 63

Company: BioLineRx Ltd.
Filing Date: 2025-03-31
Form: 20-F
Item: Item 3
Chunk 63
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by using 4-6 injections of granulocyte colony-stimulating factor, or G-CSF, the current standard of care.

In December 2017, we commenced a randomized, placebo-controlled
Phase 3 registrational trial for motixafortide, known as the GENESIS trial, for the mobilization of HSCs for autologous transplantation
in patients with multiple myeloma. The trial began with a lead-in period for dose confirmation, which was to include 10-30 patients and
then progress to the placebo-controlled main part, which was designed to include 177 patients in more than 25 centers. Following review
of the positive results from treatment of the first 11 patients, the Data Monitoring Committee, or DMC, recommended that the lead-in part
of the study be stopped and that we should move immediately to the second part. Additional positive results from the lead-in period were
reported at the annual meeting of the European Society for Blood and Marrow Transplantation held in March 2019, where it was announced
that HSCs mobilized by motixafortide in combination with G-CSF were successfully engrafted in all 11 patients.

In August 2020, we announced a decision to perform an interim analysis
on approximately 65% of the original study sample size, primarily based on a significantly lower-than-anticipated patient-dropout rate
in the study. In October 2020, we announced positive results from the interim analysis. Based on the statistically significant evidence
favoring treatment with motixafortide, the study’s independent DMC issued a recommendation to us that patient enrollment may be
ceased immediately, without the need to recruit all 177 patients originally planned for the study. In accordance with the DMC’s
recommendation, study enrollment was completed at 122 patients. In May 2021, we announced positive top-line results from the Phase 3 trial.
Based on an analysis of data on all 122 enrolled patients (the intent to treat population) we 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 (p<0.0001).
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 - an 8.2-fold