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BioLineRx Announces Receipt of Approval to Commence Phase II/III CLARITY Clinical Trial of BL-1020

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BioLineRx has announced that it has received approval from the Indian regulatory authorities and the Indian local ethics committees to commence the Phase II/III CLARITY clinical trial of BL-1020, a first in class, orally available, GABA-enhanced antipsychotic for the treatment of schizophrenia.

In June 2011, BioLineRx announced the commencement of patient enrollment in the CLARITY trial in Romania, which is currently ongoing according to schedule.

The Initiation Visits at the first few Indian clinical research centers will be completed in November, with enrollment of the first patient expected in December.

Additional centers in India will also be joining the trial over the coming weeks. Overall, the trial is expected to be conducted at approximately 18 sites in India, 14 sites in Romania and four sites in Israel.

"The approval to commence the trial in India represents an important milestone in the progress of the BL-1020 CLARITY trial. In addition, we are also intending to submit in the near future a regulatory package to the authorities in Israel in order to open four Israeli sites for our clinical trial. The trial, if successful, will support BL-1020's unique potential as an antipsychotic therapy that also improves cognition,” stated Dr. Kinneret Savitsky, CEO of BioLineRx.

Dr. Savitsky continued, "We look forward to announcing top-line results from the CLARITY trial in early 2013. Also, concurrent with the progress of the trial and in accordance with our business strategy, we have renewed our efforts to seek an out-licensing partner to continue development and commercialization of BL-1020.”

The CLARITY trial is a randomized, double-blinded, positive-controlled study that will enroll up to 450 patients experiencing an acute exacerbation of schizophrenia.

The goal of the study is to determine the short-term and long-term cognitive efficacy as well as the anti-psychotic efficacy, safety and tolerability of BL-1020 in schizophrenia patients, over periods of six, 12 and 24 weeks.

Risperidone, an approved and widely used schizophrenia drug, serves as the positive control for antipsychotic efficacy.

The cognition primary endpoint measure will utilize the MATRICS Cognitive Consensus Battery (MCCB), and cognitive benefit will be assessed by comparing the change from baseline in total MCCB score, comparing BL-1020 to Risperidone at the landmarks of six, 12 and 24 weeks.

The original protocols for the study included a placebo arm for the first six weeks of the study; however, this arm was removed from the protocols at the request of the regulatory authorities.