XTL BIOPHARMACEUTICALS LTD - Initiation of Patient Dosing in XTL-2125 Clinical Trial

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XTL BIOPHARMACEUTICALS LTD - Initiation of Patient Dosing in XTL-2125 Clinical Trial

Thursday, May 04, 2006 1:00:00 AM ETXTL Biopharmaceuticals Ltd. initiates patient dosing in Phase 1 clinical trial of XTL-2125, an oral, non-nucleoside polymerase inhibitor for the treatment of hepatitis C Study will assess safety and anti-viral activity of XTL-2125 in chronic hepatitis C patients New York, NY, May 4, 2006 - XTL Biopharmaceuticals Ltd. ("XTLbio") (NASDAQ:XTLB; LSE: XTL; TASE: XTL) today announced the initiation of patient dosing ina Phase 1 clinical trial of XTL-2125 for the treatment of chronic hepatitis C.The Phase 1 trial is a placebo controlled, randomized, dose escalating study,which will evaluate the safety, tolerability and antiviral activity of singleand multiple doses of XTL-2125. The study will enroll 48 patients into 6cohorts comprised of 8 patients each (of which 2 are placebo patients). Eachpatient will receive a single dose, followed by a 14-day multi-dosing regimencommencing one week after the single dose administration.XTL-2125 is an oral non-nucleoside hepatitis C virus polymerase inhibitor. Inpre-clinical studies, XTL-2125 has demonstrated robust activity against thehepatitis C virus in both cell-based and in-vivo systems. In addition, XTL-2125has demonstrated a good safety profile in multiple animal species.Ron Bentsur, XTLbio's Chief Executive Officer, commented: "With thecommencement of dosing in the XTL-2125 Phase 1 trial, XTLbio is in the uniqueposition of having 2 novel compounds - XTL-2125 and XTL-6865 - in clinicaltrials in patients with chronic hepatitis C. We look forward to generatingantiviral activity data from both studies over the next 12 months." Mr. Bentsuradded, "The initiation of patient dosing in the XTL-2125 study on scheduledemonstrates our strong commitment to meeting the timelines that we have setout for our programs."Investor Relations Contact:Ron BentsurTel: +1-212-531-5971rbentsur@...ABOUT XTL BIOPHARMACEUTICALS, LTD.XTL Biopharmaceuticals Ltd. ("XTLbio") is engaged in the acquisition,development and commercialization of therapeutics for the treatment ofinfectious diseases, with a focus on hepatitis C. XTLbio is developing XTL-2125- a small molecule, non-nucleoside inhibitor of the hepatitis C viruspolymerase. XTL-2125 is currently in a Phase 1 clinical trial in chronichepatitis C patients. XTLbio is also developing XTL-6865 - a combination of twomonoclonal antibodies against the hepatitis C virus - presently in Phase 1clinical trials in patients with chronic hepatitis C. XTLbio's hepatitis Cpipeline also includes several families of pre-clinical hepatitis C smallmolecule inhibitors. In addition, XTLbio has out-licensed to CubistPharmaceuticals an antibody therapeutic against hepatitis B, HepeX-B, which hasrecently completed a Phase 2b clinical study in hepatitis B liver transplantpatients. XTLbio is publicly traded on the NASDAQ, London, and Tel-Aviv StockExchanges (NASDAQ: XTLB; LSE: XTL; TASE: XTL).Cautionary StatementSome of the statements included in this press release, particularly thoseanticipating future financial performance, clinical and business prospects forour clinical compounds for hepatitis C, XTL-2125 and XTL-6865, growth andoperating strategies and similar matters, may be forward-looking statementsthat involve a number of risks and uncertainties. For those statements, weclaim the protection of the safe harbor for forward-looking statementscontained in the Private Securities Litigation Reform Act of 1995. Among thefactors that could cause our actual results to differ materially are thefollowing: our ability to successfully complete cost-effective clinical trialsfor the drug candidates in our pipeline which would affect our ability tocontinue to fund our operations with our available cash reserves, our abilityto meet anticipated development timelines for the drug candidates in ourpipeline due to recruitment, clinical trial results, manufacturing capabilitiesor other factors; and other risk factors identified from time to time in ourreports filed with the Securities and Exchange Commission and the London StockExchange. Any forward-looking statements set forth in this press release speakonly as of the date of this press release. We do not intend to update any ofthese forward-looking statements to reflect events or circumstances that occurafter the date hereof. This press release and prior releases are available athttp://www.xtlbio.com The information in our website is not incorporated byreference into this press release and is included as an inactive textualreference only.END

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