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June 11, 2014
07:01 EDTBLRXBioLineRx receives notice of allowance for U.S. patent
BioLineRx announced that a Notice of Allowance has been issued by the United States Patent and Trademark Office for a patent claiming the composition of BL-7010, a novel polymer for the treatment of celiac patients. This patent, when issued, will be valid until at least 2026. Additional patents claiming the BL-7010 composition and use thereof are granted or pending in Europe, Japan, Canada, Israel, India, China, Brazil, Russia, Australia, South Africa and Hong Kong. CEO Kinneret Savitsky said, "BL-7010 for the treatment of celiac disease is one of our lead clinical programs. We are currently testing its safety and tolerability in a Phase 1/2 trial in well-controlled celiac patients. We previously announced successful completion of the single-dose escalation part of the study, and the 14-day, repeated administration part of the study is currently ongoing. We look forward to the results of this Phase 1/2 trial, expected in the next few weeks, which will enable selection of the optimal dose for future development. Following completion of this study, we plan to commence a randomized, controlled efficacy study in celiac patients."
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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-8040ís 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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