Preliminary results from a small open-label Phase 2 study of BioLineRx's (BLRX -4.2%) lead product candidate BL-8040 showed that a single injection of BL-8040 mobilized sufficient amounts of cells required for transplantation at a similar level of efficacy to 4 - 6 injections of granulocyte colony-stimulating factor (G-CSF), the current standard of care. All recipients have experienced successful neutrophil (type of white blood cell) engraftment.
Part 1 of the study involves 10 donor/recipient pairs consisting of 10 patients with advanced blood cancers and their HLA-matched sibling donors. If no safety signals are observed regarding graft failure or rejection, the study will advance to Part 2 which will enroll 24 donor/recipient pairs, either matched siblings or haploidentical (HLA-matched) donors. Top-line data are expected by year-end.
The value proposition of BL-8040 compared to G-CSF is more rapid mobilization of hematopoietic stem cells in a more patient-friendly way. BL-8040 is dosed once with up to a two-day collection regimen versus four-to-six daily injections of G-CSF and one-to-four apheresis sessions.
BL-8040 is a short peptide for the treatment of acute myeloid leukemia, solid tumors and certain hematological indications. It functions as a high-affinity antagonist for CXCR4, a chemokine receptor that is directly involved in tumor progression, angiogenesis, metastasis and cell survival. CXCR4 is over-expressed in more than 70% of human cancers and its expression often correlates with disease severity.
Shares were up almost 8% before retracing.