Key Developments: Bioline RX Ltd (BLRX.PH)
2 May 2013
Latest Key Developments (Source: Significant Developments)
BioLine Rx Ltd announced results from the Phase IIb EAGLE trial for BL-1020, that BL-1020 demonstrated a increase in efficacy at improving cognitive impairment associated with this condition, as compared to the original analysis of the study. The findings pertain to the results of the Phase IIb EAGLE study, first published in September 2009, for determining safety, efficacy, and tolerability of BL-1020 compared to Risperidone, an approved atypical antipsychotic drug, and placebo. Results of the study showed that BL-1020 was significantly better than the placebo and comparable with Risperidone in both PANSS and CGI scores, which are widely recognized measures of severity and improvement in schizophrenia. In addition, the results showed a statistically significant improvement in cognitive function as assessed by BACS (Brief Assessment of Cognition in Schizophrenia), when compared to both placebo and Risperidone. Results of the re-analysis clearly show that when the time of day for administration of the neurocognitive BACS test was consistent between visits, the beneficial effect of BL-1020 on cognitive function was even more pronounced than the original analysis. Specifically, the original analysis for all patients in the study showed an effect size of 0.40 for BL-1020 versus placebo and an effect size of 0.39 for BL-1020 versus Risperidone. Full Article
BioLine Rx Ltd Signs Worldwide License Agreement with Clal Biotechnology Industries's Biokine Therapeutics Ltd
BioLine Rx Ltd announced that it has signed an exclusive, worldwide license agreement with Biokine Therapeutics Ltd., a Clal Biotechnology Industries portfolio company, for the development and commercialization of BL-8040 (formerly BKT-140), a Phase II ready drug candidate for the treatment of acute myeloid leukemia (AML), as well as other types of hematological cancer. There are no upfront payments due pursuant to the agreement. BioLineRx is obligated to pay a monthly development fee ranging from $50K to $100K for certain development services that Biokine has committed to provide under the agreement. If the agreed-upon clinical development plan is completed within certain defined timelines, BioLineRx is obligated to pay Biokine a milestone payment of $250K. The agreement does not contain any other milestone payments. Upon any sub-licensing transaction to a third party, BioLineRx is required to pay Biokine a royalty payment on a sliding scale, beginning at 60% of the amounts received as consideration in connection with the sublicensing, and decreasing to 40% of such consideration, based on the aggregate amount of BioLineRx’s investment in the project. Closing of the transaction is subject to formal approval of the Office of the Chief Scientist of Israel’s Ministry of Industry, Trade and Labor. Full Article
- Israeli biopharmaceutical firm BioLineRx said it would stop a trial of its experimental schizophrenia drug after an interim analysis of study data showed the drug would not meet the main goal of improving cognitive functions, sending the company's stock tumbling 58 percent to a life low.