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BioLineRx Initiates a Clinical Receptor-Occupancy Study of BL-1020, First in Class GABA-Enhanced Antipsychotic for the Treatment of Schizophrenia

Posted on: Wednesday, 16 May 2007, 09:00 CDT

BioLineRx Ltd. (TASE:BLRX), Israel's leading drug development company, announced today the initiation of a study to determine the clinical binding properties of BL-1020 to the dopamine receptors in the human brain. The trial, which is being conducted following the successful filing of an investigational new drug (IND) application with the U.S. Food and Drug Administration, is designed as a single-center, randomized, open-label, sequential cohort clinical study to be conducted at Uppsala, Sweden. The results of the study will provide further data related to the anticipated efficacy of the BL-1020 compound - the first GABA enhanced antipsychotic clinical candidate for the treatment of schizophrenia. The trial will also supply additional safety, tolerability and pharmacokinetic data.

BioLineRx expects to initiate its Phase II maximal tolerated dose clinical trial for BL-1020 in the end of June, 2007 as anticipated. The Phase II trial sites have already been selected in Romania and Israel and an investigator meeting is planned for mid-June.

"We are looking forward to the results of this receptor occupancy study that we believe will provide important information regarding the mechanism of action and efficacy of the BL-1020 compound," Morris C. Laster, MD, chief executive officer of BioLineRx stated. "We believe that BL-1020 holds great potential as a next generation antipsychotic which will be efficacious with minimal therapy-limiting side effects."

About BL-1020

BL-1020 is an orally available GABA enhanced antipsychotic clinical candidate for the treatment of schizophrenia. Data from preclinical and phase I studies demonstrated that the compound may retain the efficacy of currently available typical and atypical antipsychotic drugs while achieving a much higher safety profile as evidenced by a lack of metabolic or extrapyramidal side effects.

BL-1020 is being developed by BioLineRx, Ltd. under a worldwide exclusive license from Ramot at Tel Aviv University Ltd. and Bar-Ilan Research and Development Company Ltd., the technology transfer arms of Tel Aviv University and Bar-Ilan University respectively. BL-1020 was discovered by Professor Abraham Nudelman from the Department of Chemistry, Bar-Ilan University; and Ada Rephaeli, Ph.D., Professor Abraham Weizman, MD, and Irit Gil-Ad, Ph.D. from the Sackler Faculty of Medicine, Tel Aviv University.

About Schizophrenia

Schizophrenia is a serious mental disorder that affects about 1% of the world's population. It is a multifactorial disease characterized by delusions and hallucinations, emotional withdrawal and apathy, poor attention and disorganization. In 2002, the overall cost of schizophrenia in the United States was estimated at $62.7 billion, and the market for schizophrenia therapy in the U.S. is estimated to reach approximately $10 billion in 2012.

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 for schizophrenia and treatment of damaged heart tissue post-myocardial infarction. 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, regulatory approval and marketing. Partnering with researchers, universities and biotech companies to further the commercialization of promising compounds, BioLineRx seeks to enrich the pipeline of large pharmaceutical companies seeking their next blockbuster drugs. The Company was founded in 2003 by leaders in the Israeli life science arena including Teva Pharmaceuticals Ltd, Giza, Pitango, Hadasit and the Jerusalem Development Authority. For more information, please visit www.biolinerx.com.

This press release contains "forward-looking statements." These statements include words like "may,""expects,""believes,""scheduled" and "intends," and describe opinions about future events. These forward-looking statements involve known and unknown risks and uncertainties that may cause the actual results, performance or achievements of BioLineRx to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements.

Source: Business Wire

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