- Interim results are expected by the end of 2013 -
The study is an open-label trial to evaluate the efficacy, safety and
tolerability of BL-8020 in patients infected with HCV. It will be
conducted at two clinical sites in
BL-8020 is an orally available HCV treatment with a unique mechanism of action that targets the host cell, and thus differs from other currently used anti-HCV agents. This suggests pan-genotypic efficacy and the ability to be combined with other HCV therapeutics as part of an interferon-free regimen. BL-8020’s mechanism of action involves the inhibition of HCV-induced autophagy in the host cells. Autophagy is a mechanism by which cells degrade damaged or unnecessary cellular components, and is known to be used by HCV during viral replication. BL-8020 inhibits the autophagy mechanism and thus reduces the ability of HCV to replicate in the human cell.
BL-8020’s safety and efficacy have been demonstrated in a number of pre-clinical studies. These studies have shown that BL-8020 has a synergistic effect with other anti-HCV agents. This effect on other therapies is likely to increase their potency and reduce the numerous adverse effects often associated with these drugs by enabling utilization of lower dosages. The use of multiple therapies with different modes of action is also likely to be beneficial for patients who have developed resistance or do not respond to current treatments and is a common practice in current HCV treatment regimens.
“We are very pleased with the initiation of a clinical trial for our
first anti-HCV agent, BL-8020. HCV induces a chronic infection in over
one-half of individuals infected and, depending on the virus genotype,
as few as 60% completely recover. In addition, current standard-of-care
treatment options are lengthy and not well tolerated,” stated Dr.
“We are also excited about the initiation of the Phase I/II clinical
trial with BL-8020,” stated Professor
BL-8020 was licensed under a worldwide, exclusive agreement from
Genoscience, a French company focused on viral disease therapeutics. It
was developed as an anti-viral therapy by Professor
About Hepatitis C
Hepatitis C infection is a blood-borne infection of the liver caused by
the Hepatitis C virus (HCV) which becomes chronic in about 85% of cases.
According to a 2011 report from
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 seven 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
Various statements in this release concerning BioLineRx’s future
expectations, including specifically those related to the development
and commercialization of BL-8020, 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
KCSA Strategic Communications
Garth Russell / Todd Fromer
1 212-896-1250 / 1 212-896-1215
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