XTL Provides Update on Phase I Clinical Trial of XTL-2125
June 06 2007 - 2:53AM
PR Newswire (US)
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." 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. DATASOURCE: XTL
Biopharmaceuticals Ltd CONTACT: Contact: Ron Bentsur, Chief
Executive Officer, Tel: +1-(845)-267-0707 ext. 225
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