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BioLineRx Reports Publication of Positive Phase 1/2 Results in Stem Cell Mobilization

Published: Friday, November 22, 2013
Last Updated: Friday, November 22, 2013
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Additional clinical trial in stem cell mobilization expected to commence in H1 2014.

BioLineRx has 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.

High-dose chemotherapy followed by autologous stem cell transplantation has emerged as an established treatment modality for a variety of hematologic malignancies, including multiple myeloma, non-Hodgkin lymphoma and Hodgkin lymphoma.

Stem cells are mobilized from the bone marrow using granulocyte colony-stimulating factor (G-CSF), harvested from the peripheral blood by apheresis, and re-infused to the patient after chemotherapy. This type of treatment often replaces the more traditional use of bone marrow transplantation, because the stem cells are easier to collect and the treatment allows for a quicker recovery time and fewer complications.

In patients that do not respond well enough to G-CSF (up to 20% in multiple myeloma), treatment is often augmented by Plerixafor, a drug that inhibits CXCR4, a chemokine receptor that is important in hematopoietic stem cell homing to the bone marrow. However, even after the dual treatment, the mobilization of a sufficient number of stem cells remains a difficult objective in a sizeable proportion of patients.

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 G-CSF, resulting in a rapid and robust stem cell mobilization therapy that is differentiated from the current standard of care.

This 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.

Dr. Kinneret Savitsky, Chief Executive Officer of BioLineRx, said, "We are very pleased with these promising results in stem cell mobilization, which are the basis for our decision to initiate an additional clinical trial for BL-8040 in this indication. In addition, 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."

Professor Arnon Nagler, Director of Hematology and Bone Marrow Transplantation Division at Sheba Medical Center, Israel and the lead principal investigator of the study, commented, "The use of peripheral blood as a source of hematopoietic stem cells for transplantation in cancer patients after high-dose chemotherapy has largely replaced traditional bone marrow transplantation. In order for this treatment to succeed, a sufficient amount of stem cells needs to be mobilized from the bone marrow into the blood stream, preferably in the first mobilization attempt and ideally with a minimum of apheresis sessions. BL-8040 offers a real solution for this need, enabling robust and reproducible stem cell mobilization in multiple myeloma patients."

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