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BioLineRx Reports Successful Top-Line Safety and Efficacy Results

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BioLineRx Ltd. has announced successful top-line results from the Phase 1 safety and efficacy study of its lead clinical candidate, BL-8040, as a novel approach for mobilization and collection of bone-marrow stem cells from the peripheral blood circulation.

All safety and efficacy endpoints were met, showing that treatment with BL-8040 as a single agent was safe and well tolerated at all doses and resulted in efficient stem cell mobilization and collection in all study participants. Importantly, the results support BL-8040 as one-day, single-dose collection regimen, which is a significant improvement upon the current standard of care.

Robust stem cell mobilization was evident in all treated participants, across the different doses tested, supporting a novel approach to stem cell collection. After a single administration, BL-8040 enabled collection of a yield of stem cells that exceeds the number required to support a transplant in all treated participants, following only one collection procedure. The Company intends to present the full set of study results at the European Hematology Association (EHA) Conference taking place in Vienna in June 2015.

Dr. John DiPersio, Chief of the Division of Oncology at Washington University School of Medicine in St. Louis, stated, “I am very impressed and encouraged by the activity of BL-8040 in promoting stem cell mobilization and collection as a single agent. The robust effect seen in all participants substantially differentiates this compound from the currently approved mobilization regimens, which require four to five days of treatment and one to three full-day apheresis sessions, and can be associated with side effects including bone pain. Therefore, a novel agent with the capacity to rapidly mobilize substantial amounts of stem cells, while providing a shorter and better tolerated drug administration and cell collection regimen, will be of great value both medically and in terms of patient comfort.”

“We are very enthusiastic about the study results showing the outstanding activity of BL-8040 in promoting stem cell mobilization. The results exceeded our expectations, and validate BL-8040 as a highly differentiated stand-alone treatment for stem-cell collection. We plan to meet with the FDA as soon as practicable, in order to discuss the results of this study and obtain more clarity on the next steps in the clinical development program for this indication,” commented Dr. Kinneret Savitsky, CEO of BioLineRx. “In addition to stem-cell mobilization, our BL-8040 platform is also undergoing a Phase 2 study for treating relapsed and refractory acute myeloid leukemia patients, results of which are expected in the second half of 2015. In addition, as recently reported, we expect to commence clinical trials for three additional indications for BL-8040 in the second quarter of 2015.”

The Phase 1 safety and efficacy study consisted of two parts. The first part was a randomized, double-blind, placebo-controlled, dose escalation study exploring the safety and tolerability of escalating repeated doses of BL-8040 in three cohorts of eight healthy volunteers.

Based on data from the first part, an optimal safe and efficacious dose of BL-8040 was selected, which was used as a stand-alone therapy in a single cohort of eight healthy volunteers in the second open-label part of the study. This part of the study was designed to assess BL-8040’s stem cell mobilization capacity, as well as the yield of cells collected by apheresis.

Secondary efficacy endpoints of the study included the pharmacodynamic and pharmacokinetic profile of the drug, as well as an evaluation of the viability and biological activity of cells mobilized by BL-8040 and collected by apheresis.