BioLineRx announces positive preclinical results for novel treatment for chronic myeloid leukemia

Results of the study were recently published in Molecular Cancer Therapeutics.

The study, led by Dr 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 showed 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 95% suppression. Most importantly, the novel drug reversed the protective effect of the bone marrow stroma on CML cells, effectively promoting their apoptosis.

BioLineRx CEO Dr Kinneret Savitsky noted these encouraging results support the rationale for BL-8040 therapy, in combination with tyrosine kinase inhibitors, to override drug resistance and suppress residual disease.

"The study shows that BL-8040 has the potential to treat CML patients who have developed resistance to Gleevec. BL-8040 is currently undergoing a Phase 2 trial for AML and is expected to enter a Phase 1 trial for stem cell mobilization in the second quarter of this year, with top-line results for both of these studies expected in the fourth quarter of 2014.

"We have high hopes that this promising drug will realize its potential to help cancer patients, both as a stand-alone therapy and in combination with other therapies in the foreseeable future," Dr Savitsky added.