BioLineRx Announces Positive Results From Phase 2a Interim Trial Analysis of BL-1020 for the Treatment of Patients With SchizophreniaJERUSALEM--(BUSINESS WIRE)--Oct 29, 2007 - BioLineRx Ltd. (TASE:BLRX), today announced positive interim results from an ongoing Phase 2 trial of BL-1020, a GABA enhanced antipsychotic. The study is an open-label, multi-center, 6-week trial conducted in hospitalized patients with treatment resistant schizophrenia, in which BL-1020 showed statistically significant efficacy with minimal side effects. The assessment was part of a planned review by an Independent Safety Monitoring Board (ISMB) that reviewed the first 20 schizophrenic patients that completed 21 days of the study.
"These results from severely ill treatment resistant patients with psychosis are extremely encouraging, as they further substantiate existing preclinical and clinical data suggesting that BL-1020 possesses the efficacy of currently available antipsychotics but without their compliance limiting motor or metabolic side effects," commented Morris C. Laster, MD, CEO of BioLineRx. "Based on the medical need for novel therapeutics to address the severe unmet medical need for schizophrenia, and the preliminary findings in this study, we believe that BL-1020 has the potential to be a significant advance in the treatment of patients with schizophrenia."
Preliminary evidence of efficacy was obtained from the analysis of the Positive and Negative Syndrome Scale (PANSS) and Clinical Global Impression (CGI) scores, both of which are widely recognized measures of the severity of schizophrenia. Analyses showed that BL-1020 treatment reduces the PANSS total score by 26.1 points from the baseline (p less than 0.001) (baseline=85.6, day 42=58.2). There was a significant (p less than 0.001) improvement in PANSS negative score by 7.1 points when compared to baseline values (baseline=20.5, day 42=13.4). Furthermore, CGI results showed that 92.35% of patients improved by at least one category by the end of this part of the study.
The ISMB review of BL-1020 characterized the adverse events as being minimal to mild and not treatment-limiting. Nineteen (95%) of the twenty patients reached the maximum dose, two patients withdrew, only one of them due to side effects. No weight gain was noted. Review of ECGs, laboratory results, vital signs and adverse events did not indicate any systematic pattern of adverse change associated with BL-1020 treatment. Based on the data, the ISMB unanimously recommended continuation of the study as designed.
BL-1020 is an orally available GABA enhanced antipsychotic clinical candidate for the treatment of schizophrenia. Data from preclinical and Phase 1 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.
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.
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. 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.
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Yuri Shoshan, +972-2-548-9100
VP Finance and Corporate Development
Tsipi Haitovsky, +972-52-598-9892 (Media Liaison)
Stern Investor Relations, Inc.
Melanie Friedman, 212-362-1200
Posted: October 2007