XTL Announces the Completion of Phase I Study With XTL-6865 in Patients With Chronic Hepatitis C
29 March 2007 - 7:30PM
PR Newswire (US)
NEW YORK, March 29 /PRNewswire-FirstCall/ -- XTL Biopharmaceuticals
Ltd. (NASDAQ:XTLB)(LSE:XTL)(TASE:XTL) announced today the
completion of the Phase I study with XTL-6865. The primary goal of
this Phase I study was to evaluate safety and pharmacokinetic
properties of XTL-6865 in patients with chronic hepatitis C.
XTL-6865, which targets the E2 envelope protein of the hepatitis C
virus, is comprised of two fully-human monoclonal antibodies and is
administered intravenously. The study enrolled 32 patients into 8
cohorts, each comprised of 3 treated patients and 1 placebo
patient. Of the 8 cohorts in the study, the first 7 were single
administration cohorts with doses ranging from 5mg to 2400mg. The
8th cohort received 1200mg for 5 consecutive days. In this study,
XTL-6865 was shown to be safe at high doses (up to 1200mg for 5
consecutive daily doses and a single dose of 2400mg). The study
also enabled the Company to establish the pharmacokinetic
properties of XTL-6865 in patients with chronic hepatitis C. For
all single doses, the t-max was reached immediately at the end of
the XTL-6865 infusion. For the highest single dose, 2400mg, the
C-max was between 500 and 1000 microg/ml and the t1/2 was
approximately 5 days. For the lower single doses, the t1/2 was 2-3
days. The study provided evidence of binding of the antibody to
circulating virus and the formation of immune complexes
(antibody-virus), believed to be important for virus neutralization
in the serum. No statistically significant changes in HCV-RNA were
observed. Given the short duration of administration of XTL-6865,
and the fact the patients in this study had a high rate of viral
replication at baseline, no significant change in viral load was to
be expected. The results of this Phase I trial potentially pave the
way for trials that would evaluate XTL-6865 in patients with
hepatitis C undergoing liver transplantation - a potential target
patient population for this drug - or in chronic hepatitis C
patients with low viral load. XTL intends to seek a collaborative
partnership for the future development of this compound. Ron
Bentsur, CEO of XTL Biopharmaceuticals, commented, "This trial
enabled us to determine the pharmacokinetic properties of XTL-6865,
and to demonstrate that it could be safely administered to patients
at high doses. This study also clearly demonstrated that the
antibody binds to the circulating virus in the serum. We believe
that XTL-6865 could potentially play a role in certain clinical
settings, such as preventing re-infection of hepatitis C following
liver transplantation or in chronic hepatitis C patients who have
low viral loads following treatment with other anti-hepatitis C
drugs. We believe this is now an appropriate time to seek to
out-license the compound." Mr. Bentsur continued, "We intend to
focus our resources on commencing our clinical program for
Bicifadine, for the treatment of diabetic neuropathic pain, and on
completing our Phase I study for XTL-2125, our small-molecule
compound for the treatment of chronic hepatitis C." 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. In
addition, XTL is developing XTL-2125 - a small molecule,
non-nucleoside inhibitor of the hepatitis C virus polymerase.
XTL-2125 is currently in a Phase I clinical trial in patients with
chronic hepatitis C. XTL is also developing XTL-6865 - a
combination of two monoclonal antibodies against the hepatitis C
virus. XTL's hepatitis C pipeline also includes several families of
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: +1-212-531-5960 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 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 start a clinical trial with Bicifadine in
2007; our ability to meet the forecast reporting deadlines for the
XTL-2125 clinical trial that we mentioned above; 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: +1-212-531-5960
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