The interim analysis will be performed by a fully independent, external Data Monitoring Committee (DMC), which will maintain complete blinding of all study data from the Company. As a result of the analysis, the DMC will provide the Company with an estimate of the total number of patients required in the study in order to achieve statistical significance on the cognitive endpoints of the study.
The Company hereby emphasizes that as the CLARITY trial is on-going and given the double-blind trial design, BioLineRx at present has no insight into the results of the interim analysis. Any media reports or comments by those outside of the Company regarding the outcome of the interim results of the CLARITY trial are merely based on speculation.
BioLineRx is a publicly-traded biopharmaceutical development company.
BioLineRx is dedicated to building a portfolio of products for unmet
medical needs or with advantages over currently available therapies.
BioLineRx’s current portfolio consists of six clinical stage candidates:
BL-1020 for schizophrenia is currently undergoing a Phase II/III study;
BL-1040, for prevention of pathological cardiac remodeling following a
myocardial infarction, which has been out-licensed to
BioLineRx’s business model is based on acquiring molecules mainly from
biotechnological incubators and academic institutions. The Company
performs feasibility assessment studies and development through
pre-clinical and clinical stages, with partial funding from the Israeli
Various statements in this release concerning BioLineRx’s future
expectations constitute “forward-looking statements” within the meaning
of the Private Securities Litigation Reform Act of 1995. These
statements include words such as “may”, “expects”, “anticipates”,
“believes”, and “intends”, and describe opinions about future events.
These forward-looking statements involve known and unknown risks and
uncertainties that may cause the actual results, performance or
achievements of BioLineRx to be materially different from any future
results, performance or achievements expressed or implied by such
forward-looking statements. Some of these risks are: risks and
uncertainties associated with market conditions and the satisfaction of
customary closing conditions related to the proposed offering. These and
other factors are more fully discussed in the “Risk Factors” section of
BioLineRx’s most recent annual report on Form 20-F filed with the