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BioLineRx Announces Promising Initial Phase 2 Results of Acute Myeloid Leukemia Treatment
Date:12/16/2013

ael. The study is comprised of two parts – the current dose escalation phase and a subsequent expansion phase at the highest tolerated dose found during the escalation phase. During the dose escalation phase, trial participants are recruited in cohorts of three patients at a time, and the dose is increased for each subsequent cohort depending on the safety and tolerability results of the previous cohort. To date, there have been no serious adverse events related to BL-8040, while the primary adverse event has been a minor and transient reaction at the injection site. The BL-8040 dosing level of the current study cohort is 1 mg/kg, with the highest planned study dose being 1.5 mg/kg.

"We are very excited about the initial results from the Phase 2 trial of BL-8040 in relapsed and refractory AML patients. This is one of our most promising clinical-stage assets, and these results provide further support for the potential of this unique drug," said Dr. Kinneret Savitsky, Chief Executive Officer of BioLineRx. "Although the trial is at an early stage and we have not yet completed the dose-escalation assessment, we already see impressive mobilization of cancer cells from the bone marrow into the blood stream at a rate that is markedly higher than that seen with other drugs tested for this indication. In addition, there are initial signs of robust apoptosis of cancer cells, similarly to what we have seen in pre-clinical studies.

"The dose escalation phase of the study requires a safety and tolerability assessment by an outside Data and Safety Monitoring Board prior to advancing to the next dose level, while the expansion phase will proceed at the optimal dose without the need for such assessment. Therefore, we expect the expansion phase of the study to proceed at a significantly faster pace than the dose escalation phase. We are looking forward to reporting further interim results at the end of the dose esca
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