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January 23, 2014
07:11 EDTBLRXBioLineRx's BL-8040 for stem cell mobilization receives Orphan Drug designation
BioLineRx has received notice from the FDA confirming an Orphan Drug Designation of BL-8040 as a treatment for stem cell mobilization, in addition to the Orphan Drug Designation previously granted to BL-8040 as a treatment for Acute Myeloid Leukemia. Orphan Drug Designation entitles the sponsor to a seven-year marketing exclusivity period, clinical protocol assistance with the FDA, as well as federal grants and tax credits.
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October 31, 2014
07:06 EDTBLRXBioLineRx announces publication of IK-5001 Phase 1,2 study
BioLineRx announced publication of the results of a previous Phase 1,2 study for IK-5001, currently named Bioabsorbable Cardiac Matrix. This first-in-man pilot study, which was completed in 2010, demonstrates that intracoronary deployment of BCM is feasible and well tolerated. BCM, which was out-licensed to Bellerophon in 2009 for further development and commercialization, is in the midst of the PRESERVATION I study, a CE Mark registration trial at over 80 sites worldwide, 16 of which are in the U.S. To date, over 280 patients have been enrolled in the study, which is designed to enroll a total of approximately 300 patients. Enrollment is expected to be completed by the end of this year, with study completion anticipated in mid-2015.

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