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BioLineRx (BLRX) recently announced that it has enrolled the first patient in a phase II study of BL-8040, for the treatment of acute myeloid leukemia (AML).

We remind investors that in Sep 2012, the rights to BL-8040 were in-licensed by the company from Biokine Therapeutics Ltd. BioLineRx is looking to develop BL-8040 for the treatment of AML and other types of hematological cancers.

The multicenter, open-label phase II study will evaluate the safety and efficacy of repeated escalating doses of BL-8040 in adults suffering from relapsed/refractory AML. Primary endpoints include safety and tolerability of BL-8040. Secondary endpoints include the pharmacokinetic profile of the candidate and an efficacy evaluation.

BioLineRx will also assess the capabilities of BL-8040 in mobilizing cancer cells from the bone marrow to the peripheral blood, and in inducing their cell death. Roughly 50 patients will be enrolled across 8 sites in the US and Israel. BioLineRx expects partial results in the fourth quarter of 2013.

As per BioLineRx, approximately 250,000 adults worldwide are diagnosed with AML every year. In spite of efforts being made to develop therapies for AML, less than 25% of patients survive 5 years after being diagnosed with the disease.

Currently available treatments include chemotherapy, radiation therapy and stem cell transplantation.

Some of the candidates developed by BioLineRx include BL-5010 for the treatment of skin lesions, BL-7040 for the treatment of inflammatory bowel disease and BL-1021 for the treatment of neuropathic pain.

BioLineRx currently carries a Zacks Rank #3 (Hold).Currently, companies like Santarus, Inc. , Jazz Pharmaceuticals (JAZZ - Analyst Report) and Salix Pharmaceuticals Ltd. (SLXP - Analyst Report) look well positioned with a Zacks Rank #1 (Strong Buy).

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