10.03.2014 12:14:03
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BioLineRx: BL-7010 Completes Dose-escalation Stage Of Phase 1/2 Study
(RTTNews) - BioLineRx (BLRX), a clinical-stage biopharmaceutical company, Monday said its novel treatment for celiac disease, BL-7010, has successfully completed the single administration, dose-escalation stage of the on-going Phase 1/2 clinical study.
Celiac disease is a chronic, autoimmune, inflammatory disease of the small intestine characterized by damage to the lining of the small intestine. It typically leads to dyspepsia, malabsorption and a variety of other symptoms.
No serious adverse events were reported and there were no dose-limiting safety issues.
Based on these positive safety and tolerability results, the company will proceed with the repeated administration stage of the study. Results are expected in the middle of 2014.
The Phase 1/2 study is a two-part, double-blind, placebo-controlled, dose escalation study of BL-7010 in up to 24 well-controlled celiac patients.
The primary objective of the study is to assess the safety of single and repeated ascending doses of BL-7010 in the study patients. Secondary objectives include an assessment of the systemic exposure, of BL-7010 in the patients.
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