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BioLineRx Initiates Phase II Trial of BL-1020, a First in Class GABA-Enhanced Antipsychotic for the Treatment of Schizophrenia.


Maximal Tolerated Dosing Trial to Begin on Schizophrenic Patients

Results of Phase IIa Trials Expected Q4 2007

JERUSALEM -- BioLineRx Ltd. (TASE:BLRX), Israel's leading drug development company, today announced the initiation of a Phase II clinical trial Noun 1. phase II clinical trial - a clinical trial on more persons than in phase I; intended to evaluate the efficacy of a treatment for the condition it is intended to treat; possible side effects are monitored
phase II
 on schizophrenic patients for the maximal tolerated dose determination of BL-1020. BL-1020 is a first in class, orally available, GABA-enhanced antipsychotic for the treatment of schizophrenia The concept of a cure as such in the treatment of schizophrenia remains controversial, as there is no consensus on the definition of "treatment" in the case of schizophrenia, although some criteria for the remission of symptoms have recently been suggested. .

"This is an important milestone in the history of BioLineRx and in the development of BL-1020," commented Morris C. Laster, MD, chief executive officer of BioLineRx. "The dose ranges in this Phase II trials are based on results in previous clinical studies, which were performed on healthy volunteers. Based on our previous results, we believe that BL-1020 has the potential to be clinically efficacious with minimal therapy-limiting side effects. We very much look forward for the results of these Phase IIa trials expected sometime during the fourth quarter of 2007."

The trial is designed as an open-label, multi-center, 6-week, sequential cohort study which is expected to be conducted in 5 centers in Israel and 12 centers in Romania. The primary objective of the study is to determine the maximal tolerated dose of BL-1020 in 60 patients with schizophrenia or schizo-affective disorder.

In preparation for the Phase II trial, BioLineRx held an international investigators meeting that was held in Jerusalem, Israel on June 14-18. Seventy psychiatric physicians and other clinical staff from total of seventeen sites in Romania and Israel participated in the meeting.

"There is a clear need for new antipsychotic drugs with increased efficacy and better tolerability, as currently available drugs while effective have patient compliance issues related to the drugs' side effect profile," said Professor Michael Davidson, Director Department of Psychiatry, Sheba Medical Center The Chaim Sheba Medical Center (Hebrew: המרכז הרפואי ע"ש חיים שיבא - תל  and the principal medical advisor of the trial. "Phase I studies have shown a very favorable safety profile for BL-1020, while retaining efficacy. We are looking forward to testing this novel compound on patients with schizophrenia."

About BL-1020

BL-1020 is an orally available GABA GABA ?.

GABA
abbr.
gamma-aminobutyric acid


GABA (gamma-aminobutyric acid)
A neurotransmitter that slows down the activity of nerve cells in the brain.
 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 Antipsychotic Drugs, Atypical Definition

The atypical antipsychotic agents, sometimes called the "novel" antipsychotic agents are a group of drugs which are different chemically from the older drugs used to treat psychosis.
 while achieving a much higher safety profile as evidenced by a lack of metabolic or extrapyramidal extrapyramidal /ex·tra·py·ram·i·dal/ (-pi-ram´i-d'l) outside the pyramidal tracts; see under system.

ex·tra·py·ram·i·dal
adj.
 side effects.

BL-1020 is being developed by BioLineRx, Ltd. under a worldwide exclusive license from Ramot at Tel Aviv University Tel Aviv University (TAU, אוניברסיטת תל־אביב, את"א) is Israel's largest on-site 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 Sackler Faculty of Medicine is a medical school which is part of Tel Aviv University in Tel Aviv, Israel.

It was named after Arthur M. Sackler, a U.S. doctor who made substantial donations to the school.
, Tel Aviv University.

About Schizophrenia

Schizophrenia is a serious mental disorder that affects about 1% of the world's population. It is a multifactorial multifactorial /mul·ti·fac·to·ri·al/ (mul?te-fak-tor´e-al)
1. of or pertaining to, or arising through the action of many factors.

2.
 disease characterized by delusions and hallucinations Hallucinations Definition

Hallucinations are false or distorted sensory experiences that appear to be real perceptions. These sensory impressions are generated by the mind rather than by any external stimuli, and may be seen, heard, felt, and even
, emotional withdrawal and apathy, poor attention and disorganization disorganization /dis·or·gan·iza·tion/ (-or?gan-i-za´shun) the process of destruction of any organic tissue; any profound change in the tissues of an organ or structure which causes the loss of most or all of its proper characters. . 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 Tel Aviv Stock Exchange

Israel's only 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 See Continuous net settlement.

CNS

See continuous net settlement (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.
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Date:Jul 25, 2007
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