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XTL Biopharm Ltd (XTL)

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Thursday 29 March, 2007

XTL Biopharm Ltd

Replacement: Completion of Phase I Study with X...



Please be advised that this announcement replaces the original released at 08:16
today. This replacement is to facilitate display by third party vendors where there
was a corruption with the symbol denoting micrograms in the second paragraph. 
The correct text appears below in full.


 XTL Announces the Completion of Phase I Study with XTL-6865 in Patients with  
                              Chronic Hepatitis C                              

New York, New York, March 29, 2007 - XTL Biopharmaceuticals Ltd. (NASDAQ: XTLB;
LSE: XTL; TASE: XTL) announced today the completion of the Phase I study with
XTL-6865. The primary goal of this Phase I study was to evaluate safety and
pharmacokinetic properties of XTL-6865 in patients with chronic hepatitis C.
XTL-6865, which targets the E2 envelope protein of the hepatitis C virus, is
comprised of two fully-human monoclonal antibodies and is administered
intravenously. The study enrolled 32 patients into 8 cohorts, each comprised of
3 treated patients and 1 placebo patient. Of the 8 cohorts in the study, the
first 7 were single administration cohorts with doses ranging from 5mg to
2400mg. The 8th cohort received 1200mg for 5 consecutive days.

In this study, XTL-6865 was shown to be safe at high doses (up to 1200mg for 5
consecutive daily doses and a single dose of 2400mg). The study also enabled
the Company to establish the pharmacokinetic properties of XTL-6865 in patients
with chronic hepatitis C. For all single doses, the tmax was reached
immediately at the end of the XTL-6865 infusion. For the highest single dose,
2400mg, the Cmax was between 500 and 1000 ug/ml and the t½ was approximately 5
days. For the lower single doses, the t½ was 2-3 days. The study provided
evidence of binding of the antibody to circulating virus and the formation of
immune complexes (antibody-virus), believed to be important for virus
neutralization in the serum. No statistically significant changes in HCV-RNA
were observed. Given the short duration of administration of XTL-6865, and the
fact the patients in this study had a high rate of viral replication at
baseline, no significant change in viral load was to be expected.

The results of this Phase I trial potentially pave the way for trials that
would evaluate XTL-6865 in patients with hepatitis C undergoing liver
transplantation - a potential target patient population for this drug - or in
chronic hepatitis C patients with low viral load. XTL intends to seek a
collaborative partnership for the future development of this compound.

Ron Bentsur, CEO of XTL Biopharmaceuticals, commented, "This trial enabled us
to determine the pharmacokinetic properties of XTL-6865, and to demonstrate
that it could be safely administered to patients at high doses. This study also
clearly demonstrated that the antibody binds to the circulating virus in the
serum. We believe that XTL-6865 could potentially play a role in certain
clinical settings, such as preventing re-infection of hepatitis C following
liver transplantation or in chronic hepatitis C patients who have low viral
loads following treatment with other anti-hepatitis C drugs. We believe this is
now an appropriate time to seek to out-license the compound." Mr. Bentsur
continued, "We intend to focus our resources on commencing our clinical program
for Bicifadine, for the treatment of diabetic neuropathic pain, and on
completing our Phase I study for XTL-2125, our small-molecule compound for the
treatment of chronic hepatitis C."

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. In addition, XTL is
developing XTL-2125 - a small molecule, non-nucleoside inhibitor of the
hepatitis C virus polymerase. XTL-2125 is currently in a Phase I clinical trial
in patients with chronic hepatitis C. XTL is also developing XTL-6865 - a
combination of two monoclonal antibodies against the hepatitis C virus. XTL's
hepatitis C pipeline also includes several families of 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-(212)-531-5960

Cautionary Statement
Some of the statements included in this press release, particularly those
anticipating future performance, clinical and business prospectsfor our
clinical compound for neuropathic pain, Bicifadine, and for our clinical
compounds for hepatitis C, XTL-2125 and XTL-6865, 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 meet the
forecast reporting deadlines for the XTL-2125 clinical trial that we mentioned
above; 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.