Schizophrenia: Israeli firm to hold clinical trial in India
A leading drug company of Israel said it will soon commence the clinical trial for treatment of Schizophrenia in India after it received approval from authorities.
Indian regulatory authorities and Indian local ethics committees have given their approval to BiolineRX Limited to commence the clinical trial of BL-1020, a first in class molecule, orally available GABA-enhanced anti-psychotic for the treatment of Schizophrenia, business daily Globes reported.
"The approval to commence the trial in India represents an important milestone in the progress of the BL-1020 CLARITY trial... The trial, if successful, will support BL-1020's unique potential as an anti-psychotic therapy that also improves cognition," Bioline CEO, Dr Kinneret Savitsky, was quoted as saying by the daily.
The company is looking forward to announcing top-line results from the trial in early 2013, Savitsky said.
Bioline said initiation visits at the Indian clinical research centres will be completed this month and the first patient is likely to be enrolled by December. The trial is expected to be conducted at 18 sites in India.
The CLARITY trial is a randomised, 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 and long-term cognitive efficacy as well as the anti-psychotic efficacy, safety and tolerability of BL-1020 in Schizophrenic patients over periods of six, 12 and 24 weeks, the daily said in its report
