Jerusalem: 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
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
"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.