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March 10, 2014
07:02 EDTBLRXBioLineRx completes dose escalation stage of study for celiac treatment
BioLineRx’s 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. 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 mid-2014. The Phase 1/2 study, taking place at Tampere Hospital in Finland 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, if any, of BL-7010 in the patients. During the first part of the study, six dose levels of BL-7010 were evaluated compared to placebo. The escalation stage reached the highest planned dose, and although the study remains blinded at this point, no serious or dose-limiting adverse events were reported.
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January 25, 2016
07:05 EDTBLRXBioLineRx's BL-7010 classified as celiac treatment by European Notified Body
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