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BioLineRx (NASDAQ:BLRX) (TASE:BLRX), a biopharmaceutical development company, announced today that a European patent has been granted claiming BL-1020's composition and its use for the treatment of schizophrenia. This patent will be valid until September 29, 2022. Member patents of this family have been granted or have received a notice of allowance in the U.S., Japan, India, China, Korea, Mexico, Israel and Australia.
In addition, several other complementary patent applications are pending worldwide claiming the crystalline form of BL-1020 and the use of BL-1020 for improving cognitive function. These patents, when issued, would be valid at least through December 2030.
In June 2011, BioLineRx announced commencement of the Phase II/III CLARITY clinical trial of BL-1020. This 450-patient trial aims to determine the short-term (6 weeks) and the long-term (24 weeks) cognitive benefit and anti-psychotic efficacy, safety and tolerability of BL-1020 in schizophrenia patients, compared with Risperidone (one of the leading schizophrenia treatments) as the positive control. The CLARITY trial is proceeding according to schedule at sites in Romania and India.
Dr. Kinneret Savitsky, CEO of BioLineRx, stated, "We are extremely pleased at receiving approval for the European Patent covering BL-1020 which joins the broad protection we have already received in other territories, securing a broad basis for our future commercial operations. We believe this represents significant further progress in the development and commercialization of BL-1020. Today, almost 1% of the world’s population suffers from schizophrenia, and in approximately 90% of the cases, it is accompanied by cognitive impairment that may severely affect daily functioning. Current therapies for schizophrenia do not address this need. BL-1020 has previously demonstrated improved cognitive function in schizophrenia patients, and we are currently conducting the CLARITY clinical trial, which has validation of BL-1020’s cognition enhancement as its primary objective. We expect to obtain results during mid-2013.”
BL-1020 is a novel, first in class, oral therapeutic for schizophrenia. Pre-clinical and clinical studies to date have shown that BL-1020 is effective at treating schizophrenia symptoms and has a good safety profile. These trials have shown that BL-1020 blocks activity of the neurotransmitter dopamine and enhances the activity of another neurotransmitter, GABA. These characteristics may contribute to the efficacy and safety of the drug. In addition, clinical trials have shown that BL-1020 improves cognitive function in schizophrenia patients. Many schizophrenia patients suffer from a significant decrease in cognitive function, which is an unmet medical need not addressed by current therapies.