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
September 17, 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): 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)(7): o
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
Incorporation
by Reference: This Form 6-K of XTL Biopharmaceuticals Ltd. dated September
17,
2007 is hereby incorporated by reference into the registration statement
on Form
F-3 (File No. 333-141529) filed by XTL Biopharmaceuticals Ltd. with the
Securities and Exchange Commission on March 23, 2007.
XTL
BIOPHARMACEUTICALS PRESENTS A NEW CLASS OF HIGHLY POTENT
SMALL MOLECULE INHIBITORS OF HEPATITIS C AFFECTING THE NS5A
TARGET AT AN INTERNATIONAL SCIENTIFIC CONFERENCE
SMALL MOLECULE INHIBITORS OF HEPATITIS C AFFECTING THE NS5A
TARGET AT AN INTERNATIONAL SCIENTIFIC CONFERENCE
Valley
Cottage, New York - September 17, 2007,
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 (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).
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
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.
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: September 17, 2007 | By: | /s/ Ron Bentsur |
|
Ron Bentsur |
||
|
Cheif Executive Officer
|
||