Data on BioLineRx’s BL-8040

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BioLineRx (BLRX) recently announced positive preclinical results on oncology candidate BL-8040 for the indication of chronic myeloid leukemia (CML).

The results of the study were published in Molecular Cancer Therapeutic.

The study was evaluating BL-8040 on a standalone basis and in combination with Novartis’ (NVS) Gleevec on the proliferation of human CML cells and on human CML tumors in mice.

The results of the study showed that treatment with BL-8040 directly suppressed cancer cell growth. BL-8040 was also effective in sensitizing CML cells that hide in the bone marrow to therapy-induced apoptosis.

The study concluded that BL-8040 has the potential to treat CML patients who have developed resistance to Gleevec.

We note that BioLineRx is also evaluating BL-8040 for the indication of acute myeloid leukemia (AML) in a phase II trial. BL-8040 is also being evaluated for the indication of stem cell mobilization. The phase I trial is expected to start in the second quarter of 2014. Top-line results from both the studies are expected in the fourth quarter of 2014.

Last month, the U.S. Food and Drug Administration (FDA) granted an orphan drug designation to BL-8040 for the treatment of stem cell mobilization. BL-8040 already enjoys an orphan drug status for the treatment of AML.

Other promising candidates in the pipeline are – BL-5010 (non-surgical removal of skin lesions); BL-1040 (ventricular remodeling following a myocardial infarction); and BL-7010 (celiac disease).

We remind investors that in Sep 2012, the rights to BL-8040 were in-licensed by BioLineRx from Biokine Therapeutics Ltd.

BioLineRx carries a Zacks Rank #2 (Buy). Other stocks which look attractive at current levels in the pharma industry include Actelion Ltd. (ALIOF) and Forest Laboratories Inc. (FRX). Both carry a Zacks Rank #1 (Strong Buy).

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