BioLineRx's BL-1040 trial passes safety review
This article was originally published in Clinica
BioLineRx's phase I/II study of its BL-1040 liquid polymer device is on track to report in the third quarter of this year, following approval from an independent safety monitoring board. The polymer treats myocardial infarction by transforming into a gel-like scaffold following its injection into damaged heart tissue. The Jerusalem, Israel-based company may now enrol an additional 25 patients into the trial, following safety assessments of the first five patients to complete at least 30 days of follow-up following treatment with BL-1040 without experiencing side-effects. Interim results presenting six-month data from the first five patients are expected during the second quarter. BL-1040 is being developed as a class III medical device under the US FDA's premarketing approval (PMA) pathway; if all goes well, the product could be approved in the US by 2012.