BioLineRx Reports Publication Of Phase 1/2 Results In Stem Cell Mobilization

(RTTNews) - BioLineRx (BLRX) announced the publication of results showing that BL-8040 (formerly known as BKT-140) enables the efficient mobilization of stem cells from the bone marrow into the peripheral blood, thus facilitating autologous stem cell transplantation in multiple myeloma patients. The research was published in the journal, Clinical Cancer Research.

BL-8040 is a novel, potent and selective inhibitor of the CXCR4 chemokine receptor. The results, obtained in 2011 and currently published in Clinical Cancer Research, show that BL-8040 binds with a very high affinity to CXCR4, and more importantly, it dissociates from the receptor in a very slow fashion.

As a result, BL-8040 has the unique ability, when compared to other CXCR4 inhibitors, to completely shut down the cell signaling process governing cell trafficking in the bone marrow. This exclusive activity of BL-8040 leads to a strong synergistic effect when combined with granulocyte colony-stimulating factor or G-CSF, resulting in a rapid and robust stem cell mobilization therapy that is differentiated from the current standard of care.

The company said that the ability of BL-8040, which was originally demonstrated in animal studies, was confirmed in patients in a phase 1/2 non-randomized, open-label, dose escalation, multi-center study in multiple myeloma patients who underwent stem cell mobilization and collection for autologous stem cell transplantation. Results of the clinical study show that BL-8040 was well tolerated at all concentrations, and that when combined with G-CSF, a single administration of BL-8040 at the highest dose (0.9 mg/kg) resulted in robust mobilization and collection of stem cells, which were then obtained through a single apheresis. Furthermore, all transplanted patients rapidly engrafted. At the highest dose, the median times to neutrophil and platelet recovery were 12 and 14 days, respectively.

Kinneret Savitsky, Chief Executive Officer of BioLineRx, said, "... we remain on track with BL-8040's on-going Phase 2 study for the treatment of relapsed and refractory acute myeloid leukemia patients, for which partial results are expected by the end of this year, with final results expected in the second half of 2014. Future development plans include additional clinical studies in stem cell mobilization and chronic myeloid leukemia, which are expected to commence during the first half of 2014."