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
June
6, 2007
Commission
File Number: 000-51310
XTL
Biopharmaceuticals Ltd.
(Translation
of registrant's name into English)
750
Lexington Avenue, 20th
Floor
New
York, New York 10022
(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
Provides Update on Phase I Clinical Trial of XTL-2125
Valley
Cottage, New York, June 6, 2007
-- XTL
Biopharmaceuticals Ltd. (NASDAQ: XTLB; LSE: XTL; TASE: XTL) announced today
that
it has completed the analysis of results from a Phase I clinical trial with
XTL-2125 in patients with chronic Hepatitis C. This Phase I trial was a placebo
controlled, randomized, dose escalating study, which evaluated the safety,
tolerability and antiviral activity of single and multiple doses of XTL-2125.
The study enrolled 56 patients into seven cohorts comprised of eight patients
each (of which two are placebo patients). Each patient received a single dose,
followed by a 14-day multi-dosing regimen commencing one week after the single
dose administration. The highest daily multi-dose regimen that was evaluated
in
the trial was 1800mg per day (600mg three times per day).
The
analysis of the data indicates that XTL-2125 was generally well tolerated.
However, HCV-RNA viral load reductions in patients treated with XTL-2125 were
not significantly different from those observed in the placebo group. Based
on
these results, XTL has decided to suspend further development of XTL-2125.
XTL’s
CEO, Ron Bentsur, commented: “The completion of this Phase I trial concludes our
research on the XTL legacy compounds that we inherited. Through an aggressive
business development effort, XTL’s new management team has successfully
reinvented the company’s product portfolio - with Bicifadine as a lead product
in late stage clinical development, and the XTL-DOS program, which is emerging
as a very promising program in Hepatitis C. We look forward to an exciting
rest
of 2007, with the initiation of a late-stage clinical trial with Bicifadine
in
chronic neuropathic pain, and the initiation of IND-enabling studies with a
novel hepatitis C inhibitor from the XTL-DOS program. We will also continue
to
opportunistically seek to broaden our portfolio through the in-licensing and
acquisitions of additional clinical stage products.”
ABOUT
XTL BIOPHARMACEUTICALS LTD.
XTL
Biopharmaceuticals Ltd. (“XTL”) is engaged in the acquisition, development and
commercialization 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 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, clinical and business prospects for our
clinical compound for neuropathic pain, Bicifadine, and for our pre-clinical
compounds for hepatitis C from our XTL-DOS program, growth and operating
strategies and similar matters, 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 start a clinical trial with Bicifadine in 2007; our ability
to
successfully complete cost-effective clinical trials for the drug candidates
in
our pipeline which would affect our ability to continue to fund our operations
with our available cash reserves, our ability to meet anticipated development
timelines for the drug candidates in our pipeline due to recruitment, clinical
trial results, manufacturing capabilities or other factors; 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: June 6, 2007 | By: | /s/ Ron Bentsur |
|
Ron Bentsur |
||
|
Chief
Executive
Officer
|
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