Form 6-K BioLineRx Ltd. For: Dec 08
BioLineRx Reports Positive Data from Ongoing Phase 2a
Study for AML Treatment at ASH conference
- Data show six-fold increase in mobilization of AML cells from bone marrow;
Treatment with BL-8040 as single agent led to 70% decrease in AML cells in
bone marrow and 3.5-fold increase in AML cell apoptosis -
Jerusalem, Israel, December 8, 2014 – BioLineRx Ltd. (NASDAQ: BLRX; TASE: BLRX), a clinical-stage biopharmaceutical company dedicated to identifying, in-licensing and developing promising therapeutic candidates, announced today that data from the on-going Phase 2a clinical trial of BL-8040 for the treatment of patients with relapsed or refractory acute myeloid leukemia (AML) were reported at the American Society of Hematology (ASH) meeting, held on December 6-9, 2014, in San Francisco.
Results reported to date in the dose-escalation stage of the Phase 2a study show that, even at the highest dose reached to date (1.25 mg/kg), there were no dose-limiting toxicity events or serious adverse events, nor early discontinuations attributable to BL-8040. Furthermore, BL-8040 triggered substantial mobilization of AML cancer cells from the bone marrow to the peripheral blood, with a median 6-fold increase of AML cells in the blood. This mobilization is crucial for exposing a higher ratio of AML cells to accompanying chemotherapy such as Ara-C. Additional results show that after only two days of BL-8040 monotherapy, there was a median decrease of approximately 70% in the amount of AML cells in the bone marrow, while the levels of normal progenitor cells remained stable. Furthermore, BL-8040 as a monotherapy showed a 3.5-fold increase in cell death (apoptosis) of AML cells, both in the bone marrow and in peripheral blood samples.
Dr. Kinneret Savitsky, Chief Executive Officer of BioLineRx, stated, “We are very encouraged by the data that we see at this stage of the Phase 2a study for BL-8040, which show substantial mobilization and robust apoptosis, and we hope that we will continue to see a dose response as we test higher doses. The dose escalation stage, which is currently ongoing, is expected to be completed early next year. In addition, we recently added the Mayo Clinic as our fourth world-class site in the U.S., and we plan to open up several additional sites in the U.S. in the next few months. We look forward to reporting results of the escalation stage, and initiating the expansion phase of the trial, in which the optimal dose of BL-8040 will be further assessed for safety as well as efficacy. The full study is expected to be completed in the second half of 2015.”