UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
Form
6-K
Report
of Foreign Private Issuer
Pursuant
to Rule 13a-16 or 15d-16
of
the Securities Exchange Act of 1934
For
December 10, 2007
Commission
File Number: 000-51310
XTL
Biopharmaceuticals Ltd.
(Translation
of registrant's name into English)
711
Executive Blvd., Suite Q
Valley
Cottage, New York 10989
(Address
of principal executive offices)
Indicate
by check mark whether the registrant files or will file annual reports under
cover Form 20-F or Form 40-F.
Form
20-F
x Form
40-F
o
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): ____
Indicate
by check mark if the registrant is submitting the Form 6-K in paper as permitted
by Regulation S-T Rule 101(b)(7): ____
Indicate
by check mark whether by furnishing the information contained in this Form,
the
registrant is also thereby furnishing the information to the Commission pursuant
to Rule 12g3-2(b) under the Securities Exchange Act of 1934.
Yes
o
No
x
If
“Yes”
is marked, indicate below the file number assigned to the registrant in
connection with Rule 12g3-2(b): 82-
N/A
XTL
BIOPHARMACEUTICALS PRESENTS DATA REGARDING ITS HEPATITIS C VIRUS SMALL MOLECULE
PROGRAM AT HEP DART 2007 - AN INTERNATIONAL SCIENTIFIC CONFERENCE ON VIRAL
HEPATITIS
Valley
Cottage, New York, December 10, 2007
- XTL
Biopharmaceuticals Ltd. (NASDAQ: XTLB, TASE: 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).
Contact:
Ron
Bentsur, Chief Executive Officer
Tel:
+1-(845)-267-0707 ext. 225
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.
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, as amended, the
registrant has duly caused this report to be signed on its behalf by the
undersigned, thereunto duly authorized.
| XTL BIOPHARMACEUTICALS LTD. | ||
| |
|
|
| Date: December 10, 2007 | By: | /s/ Ron Bentsur |
|
Ron Bentsur |
||
|
Chief
Executive
Officer
|
||