BioLineRx Announces Results from Interim Analysis of Phase II/III CLARITY Trial of BL-1020 for Schizophrenia
Management call scheduled for
“These disappointing results underscore the difficulty of treating
cognition in schizophrenia, which remains an unmet medical need,” stated
As a result of the CLARITY study termination, the Company anticipates
that planned research and development expenses will decrease for the
remainder of 2013 and part of 2014 by approximately
About Phase II/III CLARITY Study Interim Analysis
The interim analysis included data on 230 subjects, of which 168 were evaluable for analysis on the primary (six-week) cognitive endpoint. The analysis indicated no efficacy of BL-1020, in comparison to Risperidone, relative to the cognitive primary and secondary (12-week and 24-week) endpoints. However, in several statistical parameters specified in the statistical analysis plan (SAP), positive trends in cognition were observed. The Company intends to perform a complete analysis of the un-blinded study data on all patients enrolled to date in order to ascertain whether there may be future potential for the product.
Conference Call and Presentation
BioLineRx's management will hold a conference call to discuss the Phase
II/III CLARITY interim analysis results for BL-1020 today,
A replay of the conference call will be available approximately two
hours after completion of the live conference call. To access the
replay, please dial 1-877-456-0009 from the U.S. or +972-3-925-5944
internationally. The replay will be available through
About BioLineRx
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-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
Government’s
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: changes in
relationships with collaborators; the impact of competitive products and
technological changes; risks relating to the development of new
products; and the ability to implement technological improvements. 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
Source: BioLineRx
KCSA Strategic Communications
Garth Russell / Todd Fromer
1
212-896-1250 / 1 212-896-1215
grussell@kcsa.com
/ tfromer@kcsa.com
or
BioLineRx
Tsipi
Haitovsky
Public Relations
+972-52-598-9892
tsipih@netvision.net.il