XTL
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 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
rbentsur@xtlbio.com
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.
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant
has
duly caused this report to be signed on its behalf by the undersigned,
thereunto
duly authorized.
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XTL
BIOPHARMACEUTICALS LTD.
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| Date: May
30,
2006 |
By: |
/s/ Jonathan
Burgin |
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Jonathan
Burgin
Chief
Financial Officer
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