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SEC filings
6-K
BIOLINERX LTD. filed this Form 6-K on 08/20/2015
Entire Document
 
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The following table identifies our current major research and development projects:
 
Project
Status
Expected or Recent Near Term Milestone
BL-8040
1.  Phase 2 study for AML; dose expansion stage initiated
1.  Top-line results expected in Q4 2015
2.  Phase 1 study in stem cell mobilization completed
2.  Type B meeting with the FDA scheduled for October 2015 to discuss next
      steps in clinical development plan for stem cell mobilization; Phase 2 trial
      expected to commence by Q1 2016
3.  Phase 2b consolidation treatment for AML initiated
3.  Top-line results expected in Q4 2017
4.  Phase 2a study for AML patients with FLT3-ITD
     mutation in final planning stages
4.  Commencement of study expected Q4 2015
5.  Phase 2a study for hMDS and AA in final planning stages
5.  Commencement of study expected Q4 2015
BL-7010
Completed Phase 1/2 study
Determination by notified body in Europe regarding regulatory pathway classification of BL-7010 as a medical device; randomized controlled efficacy study expected to commence towards end of 2015 or beginning of 2016
BL-5010
Out-licensed to Omega Pharma
Application for CE mark expected to be submitted in Q3 2015; commercialization of first OTC indication in Europe during 2016
BL-7040
Phase 2 trial completed
Potential co-development collaboration or licensing transaction; or project termination
BL-8020
Phase 1/2 development (collaboration with Licensors)
Determination by Licensors of next steps in clinical development plan of the compound, including assessment regarding potential additional viral indications for development.
BL-1040
Completed CE registration pivotal trial (conducted by Bellerophon); primary and secondary study endpoints not achieved
Further analyses of full study data expected to be presented by Bellerophon in September at European Cardiology Association Conference; we have not yet received any notification from Bellerophon about their plans regarding the future of this program.