XTL Provides Update on Phase I Clinical Trial of XTL-2125

Jun 06, 2007, 01:00 ET from XTL Biopharmaceuticals Ltd

    VALLEY COTTAGE, New York, June 6 /PRNewswire-FirstCall/ -- 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."
     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
     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.

SOURCE XTL Biopharmaceuticals Ltd