BioLineRx Ltd. has received approval from the Israeli Ministry of Health to commence a Phase 1 trial for BL-8040, a novel treatment for mobilizing stem cells from the bone marrow for treating acute myeloid leukemia, as well as other hematological malignancies. The study is expected to begin during the third quarter of 2014 at the Hadassah Medical Center.
Dr. Kinneret Savitsky, Chief Executive Officer of BioLineRx, explains that stem cell mobilization is being used more and more as a method of collecting stem cells, instead of the traditional surgical procedure of bone marrow harvesting. Current treatment regimens, she notes, involve daily injections of G-CSF, a growth factor that stimulates the bone marrow to make white blood cells. These injections are given for 4-6 days with or without the addition of a mobilizing agent such as Plerixafor (Mozobil). A previous Phase 1/2 study in multiple myeloma patients revealed that BL-8040 given as a single injection in combination with G-CSF injections was highly effective in mobilizing stem cells. The current trial aims to evaluate the mobilization capacity of one or two injections of BL-8040 as a stand-alone therapy, which could significantly shorten treatment and reduce costs.