- Hello Jeff...Some background on the HCV treatment.
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- There are about 170 MILLION people worldwide who have
HCV. Conservative estimates in the US claim that about 4 million are HCV
positive. This does not take into account all of the people who were exposed
to HCV.
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- Patricia
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- XTL BIOPHARMACEUTICALS ANNOUNCES POSITIVE PHASE
IA CLINICAL TRIAL RESULTS FOR HEPATITIS C
-
- - First monoclonal antibody in the clinic to
show activity against the hepatitis C virus
-
- 2-14-2
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- REHOVOT, Israel - XTL Biopharmaceuticals
Ltd. (LSE: XTL) today announces positive clinical data on the antiviral
activity and safety of XTL-002, being developed for the treatment of hepatitis
C virus (HCV) infections. Results of the Phase Ia study, which included
15 chronic HCV patients, indicate that HCV viral RNA levels were reduced
in over half the patients following a single dose. No serious adverse events
were reported.
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- The single-centre study, under the regulation of the
United States Food and Drug Administration (FDA) and Ministry of Health,
Israel, was designed to test safety, tolerability and efficacy of a single-dose
of XTL-002 in chronic HCV patients. The 15 patients were divided into 5
groups, with each group receiving 0.25, 1.0, 2.5, 10 or 40mg of XTL-002
in a single intravenous infusion. HCV viral RNA levels were measured pre-infusion
and at multiple time intervals following infusion of XTL-002. In 8 out
of 15 patients, significant reduction of HCV viral RNA, ranging from 2
to 100 fold, was demonstrated following XTL-002 administration.
-
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- XTL-002 is a fully human high-affinity monoclonal antibody
which was shown to reduce viral levels of the HCV virus in XTLís
proprietary in vivo model, the HCV TrimeraXTL model. This model is being
used in conjunction with a variety of corporate and academic partners to
screen and evaluate novel compounds to treat HCV. A peer reviewed scientific
article on XTLís HCV TrimeraXTL model was recently published in
the Journal of Infectious Disease.
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- Professor Eithan Galun, Director, Goldyne Savad Institute
of Gene Therapy, Hadassah University Hospital and a principal investigator
in the study, commented:
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- "XTL-002 is a promising new therapeutic modality
for treating chronic HCV patients. In addition, XTL-002 could be employed
to prevent HCV re-infection in HCV-associated liver transplant patients,
where no drug currently exists."
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- Martin Becker, Ph.D., President and Chief Executive Officer
of XTL, said:
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- "XTL is the first company to initiate clinical trials
with a monoclonal antibody against HCV. We are pleased that the clinical
results with XTL-002, though early-stage, suggest that XTL-002 is active
against the HCV virus. XTL-002 is the most advanced drug in our broad HCV
program, which includes multiple drug candidates that are either fully
owned by XTL or co-developed with corporate partners."
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- Hepatitis C is a major public health concern. The World
Health Organization estimates that 170 million people worldwide are chronic
carriers of the hepatitis C virus, with 4 million carriers in the United
States alone. It is estimated that 25-35% of these chronic patients will
develop progressive liver disease including cirrhosis and liver cancer.
Hepatitis C is the leading cause of liver transplantation. The Center for
Disease Control estimates that in the year 2000, about 10,000 people died
in the US as a result of HCV. It is predicted that by the end of this decade,
the number of deaths in the US as a result of HCV will surpass the number
of deaths from AIDS.
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- Enquiries:
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- XTL Biopharmaceuticals Ltd Dr Martin Becker, Chief Executive
Officer Tel: +972 (0) 894 05134 Jonathan Burgin, Chief Financial Officer
XTL Biopharmaceuticals, Inc. (USA) Glenn Kazo, General Manager & Chief
Business Officer Tel: +1- 603-878-9857 Mitchell Benus, Director of Investor
Relations Tel: +1- 917-627-8602 Financial Dynamics Tel: +44 (0) 20 7831
3113 David Yates / Sarah Mehanna
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- Notes to Editors
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- XTL Biopharmaceuticals develops novel therapeutics to
treat life-threatening infectious diseases using fully human monoclonal
antibodies and small molecule drugs. XTLís competitive advantage
lies in its ability to leverage both its proprietary human tissue-based
in vivo disease models and fully human monoclonal antibodies to validate
and develop promising drug candidates. The Companyís growing pipeline
of therapies, designed to combat chronic viral infections, drug-resistant
bacteria and serious systemic fungal infections, comprises internally developed
products as well as those being co-developed with a number of biopharmaceutical
partners. For more information about XTL, visit the Companyís web
site at www.xtlbio.com.
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