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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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March 25, 2015
07:02 EDTBLRXBioLineRx says safety, efficacy endpoints met in BL-8040 Phase 1 trial
BioLineRx announced successful top-line results from the Phase 1 safety and efficacy study of its lead clinical candidate, BL-8040, as a novel approach for mobilization and collection of bone-marrow stem cells from the peripheral blood circulation. All safety and efficacy endpoints were met, showing that treatment with BL-8040 as a single agent was safe and well tolerated at all doses and resulted in efficient stem cell mobilization and collection in all study participants. Importantly, the results support BL-8040 as one-day, single-dose collection regimen, which is a significant improvement upon the current standard of care. Robust stem cell mobilization was evident in all treated participants, across the different doses tested, supporting a novel approach to stem cell collection. After a single administration, BL-8040 enabled collection of a yield of stem cells that exceeds the number required to support a transplant in all treated participants, following only one collection procedure. The Company intends to present the full set of study results at the European Hematology Association Conference taking place in Vienna in June. The Phase 1 safety and efficacy study consisted of two parts. The first part was a randomized, double-blind, placebo-controlled, dose escalation study exploring the safety and tolerability of escalating repeated doses of BL-8040 in three cohorts of eight healthy volunteers. Based on data from the first part, an optimal safe and efficacious dose of BL-8040 was selected, which was used as a stand-alone therapy in a single cohort of eight healthy volunteers in the second open-label part of the study. This part of the study was designed to assess BL-8040’s stem cell mobilization capacity, as well as the yield of cells collected by apheresis. Secondary efficacy endpoints of the study included the pharmacodynamic and pharmacokinetic profile of the drug, as well as an evaluation of the viability and biological activity of cells mobilized by BL-8040 and collected by apheresis.
March 23, 2015
09:28 EDTBLRXOn The Fly: Pre-market Movers
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07:07 EDTBLRXBioLineRx reports FY14 operating loss $15.9M vs. $15.8M last year
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March 16, 2015
15:50 EDTBLRXBroadfin reports 6% passive stake in BioLineRx
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