This was the first patient in a Phase I/II clinical trial study that is designed to assess the safety and feasibility of BL-1040 in up to 30 patients at several sites in Germany, Belgium, and Israel. The company expects to complete the first part of the trial towards the end of this year. BL-1040 is being developed as a class III medical device utilizing FDA’s pre-marketing approval regulatory pathway approach.
Morris Laster, CEO of BioLineRx, said: “This is an important milestone in the development of BL-1040, BioLineRx’s innovative product candidate, which is the first treatment that attempts to treat damaged cardiac tissue resulting from an acute myocardial infarction (MI) and addresses a tremendous unmet medical need. We plan to closely monitor this and future BL-1040 patients for safety.”