Drug development company BiolineRX Ltd. (TASE:BLRX) has increased enrollment in a phase I/II study of its BL-1040 heart muscle stabilizing drug, following a positive report from its Independent Safety Monitoring Board (ISMB).
BioLine is developing BL-1040 as a breakthrough treatment for preventing further heart damage following a heart attack, or acute myocardial infarction.
The safety board for the BL-1040 pilot study authorized the completion of the phase I/II study and enrollment of an additional 25 patients. The decision was based on safety assessments of the first 5 patients to complete at least 30 days of follow up following treatment with BL-1040 without noticeable adverse events.
BioLine CEO Dr. Morris Laster said that he expects the compound will complete the Phase 1/2 study in the third quarter, and the company hopes to partner with a global device or drug company following third quarter results. Laster said, "Business development activities have already begun, and several global biopharmaceutical and device companies are showing significant interest.”
Laster added, "BioLineRx anticipates potential initial revenues in 2009 if and when out-license agreements may be secured from the partnering of BL-1040 and/or BL-1020, our Phase 2 small molecule for the treatment of Schizophrenia that will also be available for licensing following final Phase 2b data in the third quarter of 2009."
Last week, "Globes" reported that Jerusalem-based BioLine is negotiating with US pharmaceutical giant Merck for the commercialization of the other of its two leading drugs, BL 1020 for the treatment of schizophrenia.
Laster also said that BioLine has enough funds to last through the end of 2010. "The company expects that to give them 4-5 quarters after achievement of key clinical milestones, allowing ample time to close a partnering deal," he said.
BL-1040 is being developed as a Class III medical device utilizing the US Food and Drug Administration (FDA) pre -marketing approval regulatory pathway. This expedited regulatory pathway should allow marketing of BL-1040 by 2012.
BL-1040 is a resorbable liquid polymer that is administered via the coronary artery during standard catheterization and flows into the damaged heart muscle. BioLine explains that the liquid polymerizes within the infarcted cardiac tissue and forms a protective “scaffold” that enhances the mechanical strength of the heart muscle during recovery and repair, thereby preventing pathological enlargement of the left ventricle after a heart attack. It is excreted naturally from the body within six weeks after injection, leaving behind a stronger, more stable heart muscle.
Shares in BioLine jumped 21.3% today on the Tel Aviv Stock Exchange (TASE), and are up over 58% so far in 2009. Its market cap is NIS 82.4 million.
Published by Globes [online], Israel business news - www.globes-online.com - on January 11, 2009
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