Beauline R. X advances a step in approving a drug to treat heart attacks

Five of 30 patients have already been safely treated with BL-1040 in clinical trials * Final results of the trials are expected in the third quarter of 2009

Beauline R. X., a drug development company with products in clinical and pre-clinical development stages, announced today that the independent BL-1040 pilot trial safety review committee approved the continuation of phase 1/2 of the clinical trial and the recruitment of the remaining 25 patients. The safety committee's decision is based on data from the first five patients, who were already treated with BL-1040 without negative side effects after at least 30 days of follow-up. BL-1040 is a treatment to prevent the worsening of damage to the heart muscle after a heart attack.

Myocardial infarction, or heart attack, is a major cause of morbidity and mortality in the Western world. Approximately 1.3 million nonfatal heart attacks are reported annually in the United States alone, with an incidence of approximately 600 cases annually per 100,000 residents. The market potential of BL-1040 is estimated at 4 billion dollars.

Phase 1/2 clinical trials were designed to evaluate the initial safety and efficacy of BL-1040 in 30 patients. The trials are currently underway at 6 sites in Germany and Belgium, and are expected to expand to include 4 additional sites. Intermediate results, which will include a 6-month follow-up of the first five patients, are expected to be received in the second quarter of 2009, and final results are expected in the third quarter. BL-1040 is being developed as a medical device on an accelerated FDA regulatory approval track that can allow the marketing of the device as early as 2012.

"We are very satisfied with the progress in the development of BL-1040, and anticipate that phase 1/2 of the clinical trials will be completed in the third quarter of 2009. We hope that the results of the trial will lead to an agreement with a pharmaceutical company or a global medical device company. We have already started business development activities, and a number of global pharmaceutical companies have already expressed great interest," said Dr. Maurice Lester, CEO of Bioline R. Ex.

"The company has the potential for significant revenues in 2009 if and when out-licensing agreements are granted to international companies regarding BL-1040 and/or BL-1020, a small molecule that is in phase 2 of clinical trials and intended for the treatment of schizophrenia, which is also expected to be mature For commercialization towards the end of 2009. Cash balance of Bioline R. Ex. Enough to finance its activities until the end of 2010, that is, 4-5 quarters after achieving our main clinical milestones. This period of time leaves a large breathing space for signing a cooperation agreement," added Dr. Lester.

About BL-1040

BL-1040 represents a new approach to support heart tissue damaged by an acute myocardial infarction while improving heart function and reducing mortality. BL-1040 is a liquid polymer, which is inserted through a catheter and creates a "supporting scaffold" in the damaged area of ​​the muscle that increases the mechanical strength of the heart muscle during the recovery process and prevents pathological expansion of the left ventricle of the heart due to the heart attack. The material degrades by itself within six weeks after the injection and leaves a stronger, more stable and healthier heart muscle. Development, production and commercialization rights were acquired in January 2005 from Ben-Gurion University according to a licensing agreement with BG Negev Technologies Ltd., the technology commercialization company of Ben-Gurion University. More information about BL-1040 can be found On the company's website as well as in an animated video about BL-1040.