XTL Biopharmaceuticals Presents a New Class of Highly Potent Small Molecule Inhibitors of Hepatitis C Affecting the NS5A Target
September 17 2007 - 6:22AM
PR Newswire (US)
VALLEY COTTAGE, N.Y., Sept. 17 /PRNewswire-FirstCall/ -- XTL
Biopharmaceuticals Ltd. (NASDAQ:XTLB)(LSE:XTL)(TASE:XTL) announced
today that on September 13, 2007, it presented a new class of novel
and highly potent small molecule inhibitors of hepatitis C
affecting the NS5A target at the 14th International Symposium on
Hepatitis C Virus & Related Viruses in Glasgow, Scotland
(http://www.hcv2007.com/). In an oral latebreaker presentation, the
Company described a family of pre-clinical compounds with highly
potent activity against the hepatitis C virus. Potency of these
compounds was evaluated in a replicon assay which is known to have
good correlation with clinical efficacy and is the current gold
standard for pre-clinical testing of inhibitors of Hepatitis C. In
the replicon assay, the Company's most advanced compounds had
single-digit nM (nanomolar) potency against hepatitis C genotype 1b
and low double-digit nM potency against genotype 1a. Genotypes 1a
and 1b represent 75% of the U.S. hepatitis C population, according
to the American Liver Foundation. These replicon potencies are
superior to the most advanced clinical-stage small molecule
protease inhibitors of Hepatitis C, which to date have reported
triple-digit nM potency against 1a and 1b replicons. Data presented
by the Company implicated the viral protein NS5A as the direct
target of the compounds. NS5A is essential for RNA production and
is distinct from the protease and polymerase -- the viral targets
of the more advanced Hepatitis C inhibitors in clinical
development. As such, inhibitors of NS5A are considered promising
candidates for the treatment of Hepatitis C. As a relatively new
target, only one NS5A inhibitor has entered clinical trials to date
-- A831 -- which is presently in a phase 1 clinical trial. A831 was
developed by Arrow Therapeutics, which was recently acquired by
AstraZeneca. Based on data presented at the conference, the
Company's leads appear to be over 10 times more potent than A831 in
the replicon assay. In rodent studies, when administered orally,
the Company's compounds demonstrated preferential accumulation in
the liver to concentrations that were orders of magnitude above
those required to block viral replication as predicted by the
replicon assay, with half-lives consistent with twice a day dosing
regimen, and toxicological tolerability at multiple doses. The
Company also presented data indicating an additive effect with
interferon (the current standard of care) and with the protease
inhibitor VX- 950 and retained potency against protease- and
polymerase- inhibitor resistant mutants in the replicon assay.
These findings are supportive of the potential role of the
Company's compounds in combination with interferon and other small
molecules currently in clinical development. Dr. Ira Jacobson,
Professor of Clinical Medicine and Chief of the Division of
Gastroenterology and Hepatology at Weill Medical College of Cornell
University, and an advisor to the XTL-DOS program commented:
"Chronic hepatitis C represents a tremendous unmet medical need
with millions of patients seeking safer and more efficacious
treatment options. Future treatment regimens are likely to include
combinations of novel small molecules with interferon and
ribavirin, which may eventually be replaced by cocktails of several
small molecules employing complementary mechanisms of action. The
preclinical data presented by XTL suggest that the Company's
compounds could prove, with appropriate testing in clinical trials,
to be very attractive candidates for incorporation into future
treatment regimens in combination with interferon-based therapy
and/or other small molecules presently in clinical development."
The molecules presented by the Company emerged from the Company's
DOS program, aimed at discovering novel hepatitis C inhibitors
applying a unique chemistry technology called Diversity Oriented
Synthesis. The DOS program was acquired by the Company in late
2005. About Hepatitis C There are approximately 3 million people
infected with hepatitis C in the U.S. alone. Hepatitis C
significantly increases the infected person's risk of developing
chronic liver disease, cirrhosis and liver cancer, and is the
leading cause of liver transplantation in the Western World.
Hepatitis C remains a major unmet medical need as the current
standard of care (interferon-based therapy) achieves success in
only 50% of patients infected with genotype 1 of the virus
(genotype 1 affects 75% patients in the U.S.), and has significant
side affects associated with it. About XTL Biopharmaceuticals Ltd.
XTL Biopharmaceuticals Ltd. ("XTL") is engaged in the development
of therapeutics for the treatment of neuropathic pain and hepatitis
C. XTL is developing Bicifadine, a serotonin and norepinephrine
reuptake inhibitor, for the treatment of diabetic neuropathic pain.
XTL is also developing several novel pre-clinical hepatitis C small
molecule inhibitors. XTL also has an active in-licensing and
acquisition program designed to identify and acquire additional
drug candidates. XTL is publicly traded on the NASDAQ, London, and
Tel-Aviv Stock Exchanges (NASDAQ:XTLB)(LSE:XTL)(TASE:XTL).
Cautionary Statement Some of the statements included in this press
release, particularly those anticipating future performance and
prospects of our pre-clinical compounds for hepatitis C from our
XTL-DOS program may be forward-looking statements that involve a
number of risks and uncertainties. For those statements, we claim
the protection of the safe harbor for forward-looking statements
contained in the Private Securities Litigation Reform Act of 1995.
Among the factors that could cause our actual results to differ
materially are the following: our ability to successfully complete
the pre-clinical development DOS program; our ability to clinically
develop candidates from the DOS program; and other risk factors
identified from time to time in our reports filed with the
Securities and Exchange Commission and the London Stock Exchange,
including our annual report on Form 20-F filed with the Securities
and Exchange Commission on March 23, 2007. Any forward-looking
statements set forth in this press release speak only as of the
date of this press release. We do not intend to update any of these
forward-looking statements to reflect events or circumstances that
occur after the date hereof. This press release and prior releases
are available at http://www.xtlbio.com/. The information in our
website is not incorporated by reference into this press release
and is included as an inactive textual reference only. Contact: Ron
Bentsur Chief Executive Officer Tel: +1-845-267-0707 ext. 225
DATASOURCE: XTL Biopharmaceuticals Ltd. CONTACT: Ron Bentsur, Chief
Executive Officer, XTL Biopharmaceuticals Ltd., +1-845-267-0707
ext. 225 Web site: http://www.hcv2007.com/ http://www.xtlbio.com/
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