Clinical Trials

* On April 10, 2014, BioLineRx, a clinical-stage biopharmaceutical company dedicated to identifying, in-licensing and developing promising therapeutic candidates, has announced  that Prof. Arnon Nagler, Director of the Hematology Division and Bone Marrow Transplantation Center at Sheba Medical Center, Israel, has received final regulatory approval to evaluate BioLineRx’s BL-8040 as a treatment for chronic myeloid leukemia (CML) in a Phase 1/2 clinical study. BioLineRx is currently developing BL-8040 in a Phase 2 study for treating acute myeloid leukemia (AML), and in a Phase 1 study for stem cell mobilization, as a pre-treatment for stem cell transplantation. The Company has received orphan drug designation for both these indications.
The study is designed as a Phase 1/2, randomized, dose-escalation study to assess the combination of BL-8040 with standard-of-care Imatinib for improving the response of CML patients in the first chronic phase of the disease who have achieved a less than optimal response with Imatinib alone. Primary endpoints of the study are the safety and tolerability of BL-8040 in combination with Imatinib, and the secondary endpoints include assessing the efficacy of the combination therapy in achieving improved cytogenetic and molecular response in CML patients. The study will be performed at the Sheba Medical Center, and will include up to 40 patients.

* On February 12, 2014, BioLineRx, a clinical-stage biopharmaceutical company, has announced positive pre-clinical results for BL-8040 in a third indication - as a treatment for chronic myeloid leukemia (CML). Results of the study were recently published in Molecular Cancer Therapeutics (Combination of Imatinib with CXCR4 antagonist BKT140 overcomes the protective effect of stroma and targets CML in vitro and in vivo. Katia Beider, Merav Darash-Yahana, Orly Blaier, Maya Koren-Michowitz, Michal Abraham, Hanna Wald, Ori Wald, Eithan Galun, Orly Eizenberg, Amnon Peled, and Arnon Nagler. Mol Cancer Ther molcanther.0410.2013; Published OnlineFirst February 6, 2014; doi:10.1158/1535-7163.MCT-13-0410)

The study, led by Prof. Arnon Nagler, Director of the Hematology Division and Bone Marrow Transplantation Center at Sheba Medical Center, Israel, assessed the effect of BL-8040 alone, and in combination with imatinib, on the proliferation of human CML cells in culture and on human CML tumors that were engrafted in mice. Results of the study show that the BL-8040 treatment directly inhibited cancer cell growth and induced apoptotic cell death of CML cells in vitro. Furthermore, BL-8040 had a synergistic effect with imatinib, enabling use of imatinib at low doses. In mice engrafted with CML tumors, the combination of BL-8040 with low-dose imatinib markedly inhibited tumor growth, achieving a 95% suppression. The novel drug reversed the protective effect of the bone marrow stroma on CML cells, effectively promoting their apoptosis.