Jerusalem, Israel – April 29, 2013 – BioLineRx (NASDAQ: BLRX; TASE:
BLRX), a biopharmaceutical development company, announced today
enrollment of the first patient in a Phase I/II trial for BL-8020, an
orally available, interferon-free treatment for the Hepatitis C virus
(HCV). The patient was enrolled at the Hospital Cochin in Paris, France.
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 France and will include up to 32
HCV-infected patients of any genotype who have previously failed or
relapsed following treatment with the standard-of-care. BL-8020 is a
proprietary fixed-dose combination treatment composed of Ribavirin and
Hydroxychloroquine (HCQ), which results in an improved version of
Ribavirin. The primary endpoint of the study is to evaluate the effect
of a 16-week combination therapy with Ribavirin and HCQ. The study is
specifically designed to allow intra-subject analysis, in order to
determine the extent to which HCQ enhances Ribavirin’s antiviral
activity.
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.
Kinneret Savitsky, CEO of BioLineRx. “Accordingly, there is a clear need
for new drugs that can increase the effectiveness of existing
treatments, especially in patients who have already undergone treatment,
but have previously failed to respond or relapsed. In this respect,
this study would be a first step in establishing in patients the
synergistic potential of BL-8020 in combination with other HCV
treatments. Based on its pre-clinical results, unique mechanism of
action and synergistic effect with other anti-HCV compounds, we are very
hopeful that BL-8020 will indeed enhance the activity of other
available Hepatitis C treatments, thereby improving Hepatitis C care. We
look forward to the partial results from the Phase I/II trial expected
towards the end of 2013.”
“We are also excited about the initiation of the Phase I/II clinical
trial with BL-8020,” stated Professor Stanislas Pol from H?pital Cochin
in Paris, the lead principal investigator in the study. “Preclinical
results in our ex-vivo model of infected human liver slices showed a
time and dose-dependent inhibitory effect on HCV replication and
infectivity. We hope that this drug, especially when combined with other
available Hepatitis C drugs, will improve the treatment outcome of
previously non-responsive patients,” said Professor Pol.
About BL-8020
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 Philippe Halfon,
Co-Founder and President of Genoscience and a world-renowned scientist
for his work on HIV, HPV (human papilloma virus causing cervical cancer)
and Hepatitis.
