BioLineRx to Start BL-8040 Study

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BioLineRx (BLRX) recently received approval in the US for the initiation of a multi-center, open-label phase IIa study on BL-8040. BioLineRx is looking to develop BL-8040 for the treatment of acute myeloid leukemia (:AML) and other types of hematological cancers.

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

BioLineRx expects partial results in the fourth quarter of 2013, while the final results are expected in the second half of 2014.

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

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. Eisai Co., Ltd. (ESALY) and Johnson & Johnson (JNJ) are together trying to develop Dacogen (decitabine) for AML.

BioLineRx, a biopharmaceutical company, carries a Zacks Rank #3 (Hold). We remind investors that the company suffered a pipeline setback recently with disappointing interim results being reported from the phase II/III CLARITY trial of BL-1020, being developed for the treatment of schizophrenia. The interim analysis indicated that the study will not meet its primary endpoint.

Companies like UCB (UCBJF) look well-positioned in the biopharma space. UCB carries a Zacks Rank #1 (Strong Buy).

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