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BioLineRx Receives US Approvals For Phase IIa Trial Of AML Compound BL-8040

Pharmaceutical company BioLineRx, Ltd. (BLRX) Wednesday said it has received all necessary regulatory approvals in the US to begin a Phase IIa trial for BL-8040, for the treatment of Acute Myeloid Leukemia or AML.

The study is expected to enroll up to 50 patients and be conducted in the US and Isreal. Primary endpoints of the study are safety and tolerability of the drug while secondary endpoints include the pharmacokinetic profile of the drug and an efficacy evaluation, as assessed by various parameters, such as the response rate by bone marrow biopsy.

Commenting on the development, Kinneret Savitsky, CEO of BioLineRx sid, "...In particular, treatment options for patients with relapsed or refractory AML are extremely limited, and in many cases, only palliative care is offered. We look forward to the partial results expected towards the end of this year, and have sincere hopes that BL-8040 will be a significant and efficient addition in the battle with this devastating disease."

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