XTL Biopharmaceuticals Presents Data Regarding its Hepatitis C Virus Small Molecule Program at Hep Dart 2007 - an International
December 10 2007 - 6:00AM
PR Newswire (US)
VALLEY COTTAGE, N.Y., Dec. 10 /PRNewswire-FirstCall/ -- XTL
Biopharmaceuticals Ltd. (NASDAQ:XTLBNASDAQ:TASE:NASDAQ:XTL)
announced today that it will make two scientific presentations
related to its pre-clinical Hepatitis C virus (HCV) small molecule
program at HEP DART 2007, an international scientific conference on
viral hepatitis being held this week in Lahaina, Hawaii. A poster
presentation entitled "Mechanistic Characterization of Potent Small
Molecule HCV Inhibitors that Target NS5A" describes a family of
small molecule inhibitors of HCV that target the NS5A viral
protein. 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 HCV. In the replicon assay, the compounds had
single-digit nM (nanomolar) and low double-digit nM potencies
against genotypes 1b and 1a, respectively. These genotypes
constitute the majority of HCV infections in the U.S. New data
presented further substantiate NS5A as the target of these
compounds. The new data includes results from in vitro binding to
NS5A, resistance selection, molecular genetic and molecular
modeling studies. NS5A is a viral protein that is essential for RNA
production and is distinct from the protease and polymerase - the
viral targets of the more advanced HCV inhibitors in clinical
development. As such, inhibitors of NS5A are considered promising
candidates for the treatment of HCV. 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. The Company's compounds presented appear to be
significantly more potent than A831 in the replicon assay. A second
poster presentation entitled "Pharmacologic Evaluation of Novel
Small Molecule HCV Inhibitors Affecting NS5A-dependent Functions"
describes the results of studies on the potency, specificity,
toxicology and pharmacokinetics of the Company's lead HCV
molecules. In these studies, when administered orally to rodents,
the compounds demonstrated preferential accumulation in the liver
in concentrations that were orders of magnitude above those
required to block viral replication as predicted by the replicon
assay, with half-lives consistent with a twice a day dosing
regimen. Toxicology studies showed that the activity of these
molecules was selective for HCV, with no apparent adverse effects
on a range of human cell types or on rodents exposed to repeated
high doses. The small molecules being presented by the Company at
the conference emerged from the Company's DOS program, aimed at
discovering novel HCV inhibitors by applying a unique chemistry
technology called Diversity Oriented Synthesis. ABOUT HEPATITIS C
VIRUS There are approximately 3 million people infected with HCV in
the U.S. alone. HCV infection 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. HCV infection 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 HCV. XTL is developing Bicifadine, a serotonin
and norepinephrine reuptake inhibitor, for the treatment of
diabetic neuropathic pain, which is currently in a Phase 2b study.
XTL is also developing novel pre-clinical HCV 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 and Tel-Aviv Stock
Exchanges (NASDAQ:XTLB)(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 HCV 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,
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. DATASOURCE:
XTL Biopharmaceuticals Ltd. CONTACT: Ron Bentsur, Chief Executive
Officer of XTL Biopharmaceuticals Ltd., +1-845-267-0707, ext. 225
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