BioLineRx Ltd. has announced successful completion of the dose escalation stage of its ongoing Phase 2 study of BL-8040, and commencement of the expansion stage at the optimal dose of this novel treatment for acute myeloid leukemia (AML). Top-line results from the study are anticipated in the fourth quarter of 2015.
Results of the completed dose escalation stage, in which 22 patients participated, showed that all BL-8040 tested doses, up to 1.5 mg/kg, were found to be safe and well tolerated when administered in combination with Ara-C (Cytarabine).
Building upon prior interim results, which included doses up to 1.25 mg/kg and were presented at the 2014 American Society for Hematology conference, the data indicate that BL-8040 exhibits robust single-agent activity, with a dramatic decrease in the amount of AML cells in the bone marrow and significant mobilization of these cells into the peripheral blood following two days of BL-8040 monotherapy, as well as direct induction of leukemia cell death.
Based on the study’s pharmacodynamic data, 1.5 mg/kg was chosen as the dose for use in the expansion stage of the study. In parallel to initiation of the expansion stage, additional patients will be recruited to assess one higher dose level of BL-8040, in order to further expand the therapeutic window of the drug.
“We are greatly encouraged by these interim results and are excited to commence the final stage of this important trial,” said Dr. Kinneret Savitsky, Chief Executive Officer of BioLineRx. “We expect this stage to progress much more quickly than the dose-escalation stage of the trial, which required approval from the data safety monitoring committee before moving to the next dose level. We also expect to open additional sites for this stage of the trial. We look forward with much anticipation to announcing top-line results of the trial, which we expect in the fourth quarter of this year.”
Dr. Savitsky continued, “Our expanding BL-8040 platform continues its track record of impressive achievements, including the recently reported successful top-line results from our Phase 1 safety and efficacy study for stem cell mobilization. We expect to provide the full set of results from this study at the European Hematology Association (EHA) Congress being held next month in Vienna, Austria. In addition, as previously reported, we expect to commence clinical trials for three additional indications for BL-8040 in the next few months.”