BioLineRx Ltd. has announced that it has received approval from the Israeli Ministry of Health to commence a Phase 1 trial for BL-8040, a novel treatment for the mobilization of stem cells from the bone marrow to the peripheral blood circulation.
The study is expected to commence during the third quarter of 2014 at Hadassah Medical Center in Jerusalem.
Dr. Kinneret Savitsky, Chief Executive Officer of BioLineRx, stated, “Stem cell mobilization is being used more and more as a method of collecting stem cells, either for autologous use or for donation, instead of the surgical procedure of bone marrow harvesting. Current treatment regimens involve daily injections for 4-6 days of G-CSF, with or without the addition of a mobilizing agent such as Plerixafor (Mozobil). BL-8040 given as a single injection was previously shown in a Phase 1/2 study in multiple myeloma patients to be highly effective in mobilizing stem cells in combination with G-CSF injections. 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 and reduce treatment costs. In parallel, BL-8040 is undergoing a Phase 2 study for relapsed and refractory acute myeloid leukemia patients, the results of which are expected in early 2015. We also expect the commencement of an investigator-led Phase 1/2 study in chronic myeloid leukemia patients during 2014,” concluded Dr. Savitsky.
The Phase 1 study consists of two parts. Part 1 is a randomized, double-blind, placebo-controlled dose escalation study exploring the safety and tolerability of escalating repeated doses of BL-8040 in healthy volunteers.
Secondary objectives include assessment of the efficacy of BL-8040 in mobilizing stem cells as a stand-alone therapy, as well as determining the pharmacokinetic profile of the drug. This part will be performed in up to 4 cohorts, with 8 healthy volunteers in each cohort.
Part 1 of the study will serve to select the optimal safe and efficacious dose of BL-8040 to be used as a stand-alone therapy in Part 2 of the study.
Part 2 is an open-label study designed to assess BL-8040’s stem cell mobilization capacity, as well as the yield of cells collected by apheresis.
Secondary endpoints of the study include evaluation of the viability and biological activity of cells mobilized by BL-8040 and collected by apheresis.
This part will be performed in a single cohort of 8 healthy volunteers who will receive the selected dose regimen of BL-8040 based on the data from Part 1.