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SEC filings
6-K
BIOLINERX LTD. filed this Form 6-K on 08/11/2016
Entire Document
 

The following table identifies our current major research and development projects:

Project
Status
Expected Near Term Milestone
BL-8040
1.     Phase 2a study for relapsed or refractory AML completed
 
2.     Phase 2b consolidation treatment for AML ongoing
 
3.     Phase 2 study in stem cell mobilization initiated
 
4.     Phase 2a study in pancreatic cancer, in collaboration with Merck
 
5.     Phase 2a study in pancreatic cancer, in collaboration with MD Anderson
        Cancer Center
 
1.     Detailed data to be presented at upcoming SOHO Annual Meeting in September
 
2.     Completion of enrollment by 2018. Top-line results expected in 2019
 
3.     Partial results expected by end of 2016
 
4.     Commencement of study expected in Q3 2016
 
5.     Commencement of study expected by end of 2016
BL-7010
Completed Phase 1/2 study; classified as Class IIb medical device in the EU
Submission of package for GRAS designation as food supplement in the U.S.; completion of formulation development as food supplement; initiation of clinical study for marketing purposes as food supplement; determination of appropriate timing for continued medical device development in Europe
BL-5010
Out-licensed to Omega Pharma; CE mark approval obtained; commercial launch of first OTC indication in Europe commenced
Gradual full roll-out of commercial launch over next 6-9 months; completion of development by Omega Pharma for second OTC indication; pursuit of potential out-licensing partner(s) for OTC and non-OTC rights still held by us
 
In addition to the projects set forth above, we have four additional projects in clinical and pre-clinical stages of development (BL-8020, BL-1040, BL-9020 and BL-1210) that are significantly less material to the Company’s ongoing research and development expenditures.
 
Set forth below is a summary of the costs allocated to our main projects on an individual basis, as well as the costs allocated to our less significant projects on an aggregate basis, for the years ended December 31, 2013, 2014 and 2015; for the six months ended June 30, 2016; and on an aggregate basis since project inception. Certain of such costs were covered by OCS funding, although OCS funds received have not been deducted from the direct project costs in the table.
 
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