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BioLineRx Receives Regulatory Approval to Commence Phase 1/2 Trial for Novel Treatment of Celiac Disease
Date:11/4/2013

JERUSALEM, Nov. 4, 2013 /PRNewswire/ -- BioLineRx (NASDAQ: BLRX) (TASE: BLRX), a biopharmaceutical development company, announced today that it has received regulatory approval from the Finnish National Supervisory Authority for Welfare and Health (Valvira) to commence a Phase 1/2 safety trial for BL-7010, for the treatment of celiac disease. The study is expected to begin by the end of this year.

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The Phase 1/2 study is a two-part (single and repeated), double-blind, placebo-controlled, dose escalation study of BL-7010 in up to 32 patients at a world-leading site for celiac disease research in Finland. The primary objective of the study is to assess the safety of single and repeated ascending doses of BL-7010 in well-controlled celiac patients. Secondary objectives include an assessment of the systematic exposure, if any, of BL-7010 in the study patients.

Professor Markku Maki, M.D., Ph.D., of the University of Tampere School of Medicine and the Tampere Center for Child Health Research in Finland, the responsible coordinating investigator of the trial, stated, "Celiac has become an increasingly problematic condition, with 1% of the world's current population suffering from this disease. The incidence of celiac is also expected to increase substantially in the future, with increased awareness and improved diagnostic tools. Despite the unmet medical need, the only current treatment is life-long adherence to a gluten-free diet, which is extremely difficult to maintain. Research results show that even up to 50% of patients on a gluten-free diet are still symptomatic and that small intestinal mucosal injury persists despite attempts t
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2. BioLineRx Announces Regulatory Submission for Phase 1/2 Trial for Novel Treatment of Celiac Disease
3. BioLineRx Announces Receipt of a Notice of Allowance from USPTO for Patent on Use of BL-8020, an Oral, Interferon-Free Treatment for Hepatitis C
4. BioLineRx To Present At 15th Annual Rodman & Renshaw Global Investment Conference In New York
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9. BioLineRx Reports Second Quarter 2013 Results
10. BioLineRx Announces Publication of Positive Pre-Clinical Results for BL-8040 in Treatment of Thrombocytopenia
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