BioLineRx Ltd. has announced that it has completed the dose escalation stage of a Phase 1 trial for its novel oncology platform, BL-8040, as a novel treatment for the mobilization of stem cells from the bone marrow to the peripheral blood circulation.
All healthy volunteers completed the treatment phase and results are expected during the first quarter of 2015. BL-8040 is being developed along multiple tracks for the treatment of hematological malignancies and other hematological indications, with multiple clinical milestones expected in 2015.
Dr. Kinneret Savitsky, Chief Executive Officer of BioLineRx, stated, “We are very excited about this latest advancement for our BL-8040 platform. Stem cell mobilization is used increasingly as a method of collecting hematopoietic stem cells for transplantation, forming part of the treatment regimen for certain types of hematological cancers, as well as severe anemia or immune deficiency disorders. Although it is a Phase 1 study, the current trial will provide us with efficacy data regarding the mobilization capacity of one or two injections of BL-8040 as a stand-alone therapy, which could significantly shorten and reduce the cost of treatment, as well as eliminate the painful side effects associated with G-CSF.”
“In parallel, BL-8040 is also undergoing a Phase 2 study for treating relapsed and refractory acute myeloid leukemia patients, the results of which are expected in the second half 2015. The robust mobilization of cells seen in our Phase 2 AML study to date has been very encouraging and will hopefully be reflected in our Phase 1 mobilization study.”
“As recently reported, we also expect to commence clinical trials for three additional indications for BL-8040 during 2015,” concluded Dr. Savitsky.
The Phase 1 study consists of two parts. The first part 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 pharmacodynamic and pharmacokinetic profile of the drug. This part was performed in three cohorts, with eight healthy volunteers in each cohort. Following analysis of the data, the optimal safe and efficacious dose of BL-8040 will be selected to be used as a stand-alone therapy in the second part of the study.
The second part of the study 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 eight healthy volunteers who will receive the selected dose regimen of BL-8040 based on the data from the first part of the study.