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BioLineRx Ltd. (BLRX) announced positive initial results on BL-8040 which is being evaluated in a multicenter, open-label phase II study for treating adults suffering from relapsed/refractory acute myeloid leukemia (AML).

The study is evaluating the safety and efficacy of repeated escalating doses of BL-8040. Assessment of the safety and tolerability of BL-8040 is the primary endpoint of the study while secondary endpoints include the pharmacokinetic profile of the drug and an efficacy evaluation. Initial results demonstrate BL-8040 as safe at all doses tested till date.

The study is divided into two parts. The first part of the study evaluates the current dose escalation phase. The second part is the expansion phase at the highest tolerated dose determined during the escalation phase. The dosing level of the current study cohort is 1 mg/kg, with the highest dose being 1.5 mg/kg.

Interim results are expected in the second quarter of 2014 and final study results are expected in the second half of 2014.

Meanwhile, BioLineRx is also studying BL-8040 for the treatment of thrombocytopenia (reduced platelet production). In Aug 2013, the company reported positive results from pre-clinical trials on the candidate, where it was proved to be effective for the treatment of thrombocytopenia. Results further revealed that BL-8040 increased the number of megakaryocytes (cells that produce platelets) within the bone marrow.

We remind investors that in Sep 2012, the rights to BL-8040 were in-licensed by BioLineRx from Biokine Therapeutics Ltd. BL-8040 has received orphan drug designation for the treatment of AML from the U.S. Food and Drug Administration (FDA).

BioLineRx is also looking to develop BL-8040 for other hematological indications like stem cell mobilization and chronic myeloid leukemia. These studies will commence in the first half of 2014.

With BL-8040, BioLineRx is expected to enter the oncology market. However, big companies like Roche (RHHBY - Analyst Report) and Bayer (BAYRY - Analyst Report) have a presence in the oncology market.

BioLineRx currently carries a Zacks Rank #3 (Hold). A better-ranked stock, Actelion Ltd. (ALIOF) carries a Zacks Rank #1 (Strong Buy).

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