XTL Biopharmaceuticals Ltd. Initiates Patient Dosing in Phase 1 Clinical Trial of XTL-2125, an Oral, Non-Nucleoside Polymerase
May 04 2006 - 3:13AM
PR Newswire (US)
Study Will Assess Safety and Anti-Viral Activity of XTL-2125 in
Chronic Hepatitis C Patients NEW YORK, May 4 /PRNewswire-FirstCall/
-- XTL Biopharmaceuticals Ltd. ("XTLbio")
(NASDAQ:XTLB)(LSE:XTL)(TASE:XTL) today announced the initiation of
patient dosing in a 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 single and
multiple doses of XTL-2125. The study will enroll 48 patients into
6 cohorts comprised of 8 patients each (of which 2 are placebo
patients). Each patient will receive a single dose, followed by a
14-day multi-dosing regimen commencing one week after the single
dose administration. XTL-2125 is an oral non-nucleoside hepatitis C
virus polymerase inhibitor. In pre-clinical studies, XTL-2125 has
demonstrated robust activity against the hepatitis C virus in both
cell-based and in-vivo systems. In addition, XTL-2125 has
demonstrated a good safety profile in multiple animal species. Ron
Bentsur, XTLbio's Chief Executive Officer, commented: "With the
commencement of dosing in the XTL-2125 Phase 1 trial, XTLbio is in
the unique position of having 2 novel compounds - XTL-2125 and
XTL-6865 - in clinical trials in patients with chronic hepatitis C.
We look forward to generating antiviral activity data from both
studies over the next 12 months." Mr. Bentsur added, "The
initiation of patient dosing in the XTL-2125 study on schedule
demonstrates our strong commitment to meeting the timelines that we
have set out for our programs." Investor Relations Contact: Ron
Bentsur Tel: +1-212-531-5971 About XTL Biopharmaceuticals, Ltd. XTL
Biopharmaceuticals Ltd. ("XTLbio") is engaged in the acquisition,
development and commercialization of therapeutics for the treatment
of infectious diseases, with a focus on hepatitis C. XTLbio is
developing XTL-2125 - a small molecule, non-nucleoside inhibitor of
the hepatitis C virus polymerase. XTL-2125 is currently in a Phase
1 clinical trial in chronic hepatitis C patients. XTLbio is also
developing XTL-6865 - a combination of two monoclonal antibodies
against the hepatitis C virus - presently in Phase 1 clinical
trials in patients with chronic hepatitis C. XTLbio's hepatitis C
pipeline also includes several families of pre-clinical hepatitis C
small molecule inhibitors. In addition, XTLbio has out-licensed to
Cubist Pharmaceuticals an antibody therapeutic against hepatitis B,
HepeX-B, which has recently completed a Phase 2b clinical study in
hepatitis B liver transplant patients. XTLbio is publicly traded on
the NASDAQ, London, and Tel-Aviv Stock Exchanges
(NASDAQ:XTLB)(LSE:XTL)(TASE:XTL). Cautionary Statement Some of the
statements included in this press release, particularly those
anticipating future financial performance, clinical and business
prospects 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 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. 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. DATASOURCE:
XTL Biopharmaceuticals Ltd CONTACT: Investor Relations Contact: Ron
Bentsur, Tel: +1-212-531-5971,
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