Healthcare Industry News:  schizophrenia 

Biopharmaceuticals Cardiology

 News Release - March 24, 2008

First Patient Successfully Undergoes Breakthrough Treatment for Acute Myocardial Infarction Developed by BioLineRx

BioLineRx Initiates Phase 1/2 for BL-1040 novel myocardial implant for the treatment of Acute MI

JERUSALEM--(HSMN NewsFeed)--BioLineRx Ltd. (TASE:BLRX), a clinical stage drug development company, today announced that the first patient treated with BL-1040 was released from the Department of Cardiology at the University of Heidelberg in Germany following treatment with no apparent adverse effects.

This was the first patient in a Phase 1/2 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 U.S. Food and Drug Administration’s pre-marketing approval regulatory pathway approach.

BL-1040 represents a breakthrough approach to supporting cardiac tissue damaged as a result of acute myocardial infarction (MI), improving cardiac function and survival. BL-1040 is a resorbable liquid polymer that is administered via the coronary artery during standard catheterization and flows into the damaged heart muscle. 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 the MI. BL-1040 is excreted naturally from the body within six weeks after injection, leaving behind a stronger, more stable heart muscle.

The safety, biocompatibility and efficacy of BL-1040 were demonstrated in pre-clinical trials performed in multiple species. BL-1040 improved survival and was shown to be safe and effective in preventing deterioration of the myocardium by reducing left ventricle dilatation and eventual heart failure.

"BL-1040 could revolutionize the treatment of patients recovering from a massive heart attack," said Professor Jonathan Leor, Director of the Neufeld Cardiac Research Institute at Sheba Medical Center and Tel-Aviv University, Israel who invented BL-1040 and conducted the initial experiments together with Professor Smadar Cohen from Ben Gurion University, Israel. "We look forward to the results of the trial and believe that it will continue to provide more evidence for the success of our new approach to bring effective and safe treatment for patients with injured hearts," added Professor Leor.

"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 MI and addresses a tremendous unmet medical need. We would like to thank Norbert Frey, MD, Director, Cardiac Catheterization Laboratory and Hugo Katus, MD, Chair of the Department of Medicine both at the University of Heidelberg for their collaboration and participation in this historic event. We plan to closely monitor this and future BL-1040 patients for safety,” said Morris C. Laster, MD, CEO of BioLineRx. "This is the 2nd therapeutic candidate that BioLineRx has successfully advanced from the lab to the clinic since its inception in 2003. BL-1020, the first therapeutic candidate brought from bench to bedside for the treatment of schizophrenia, is about to begin Phase 2b clinical trials on hundreds of patients in the U.S., Europe and Israel."

BL-1040 was in-licensed by BioLineRx from Ben-Gurion University through BGN Technologies, and it was developed by Professor Smadar Cohen and Professor Jonathan Leor from the Department of Biotech and Biomedical Engineering at Ben-Gurion University.

For further information on BL-1040, please visit the BioLineRx website and BL-1040 animation at http://www.biolinerx.com/PipelineSelected.asp

About Acute Myocardial Infarction

Acute MI is a leading cause of morbidity and mortality in the Western world. Approximately 1.3 million cases of nonfatal MI are reported each year in the U.S. alone, with an annual incidence rate of approximately 600 cases per 100,000 people.

About BioLineRx

BioLineRx, a clinical stage drug development company traded on the Tel Aviv Stock Exchange (TASE: BLRX), is dedicated to building a robust pipeline of promising therapeutics for unmet medical needs. The Company’s leading programs are BL-1020 for the treatment of schizophrenia, which recently completed Phase 2a trials and will commence Phase 2b trials shortly, and BL-1040 for the treatment of damaged heart tissue post-acute myocardial infarction, which is currently undergoing a Phase 1/2 study. Additional products under development include compounds for the treatment of cancer and CNS, cardiovascular, metabolic, infectious and autoimmune diseases.

BioLineRx advances projects from early stage discovery and lead generation to advanced clinical trials. BioLineRx partners with researchers, universities and biotech companies to further the development of promising compounds. The Company was founded in 2003 by leaders in the Israeli life science arena including Teva Pharmaceuticals Ltd., venture capital firms Giza Venture Capital and Pitango Venture Capital, and Hadasit, the technology transfer company of Hadassah Hospital and the Jerusalem Development Authority. For more information, please visit www.biolinerx.com.

This press release contains "forward-looking statements" that involve known and unknown risks and uncertainties including clinical results, planned clinical trials, timing, nature and achievability of regulatory approvals and other factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. In some cases, you can identify forward-looking statements by terms including "anticipates," "believes," "could," "estimates," "expects," "intends," "may," "plans," "potential," "predicts," "projects," "should," "will," "would," “hope,”“look forward” and similar expressions intended to identify forward-looking statements. Forward-looking statements reflect our current views with respect to future events and are based on assumptions and subject to risks and uncertainties. You should not put undue reliance on any forward-looking statements. Unless we are required to do so under applicable laws, we do not intend to update or revise any forward-looking statements.


Source: BioLineRx

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