XTLbio REPORTS ENCOURAGING PK RESULTS FOR HepeX(TM)-B
04 6월 2003 - 4:02PM
UK Regulatory
XTLbio REPORTS ENCOURAGING PK RESULTS FOR HepeX(tm)-B
Drug candidate meets or beats HBIg antibody levels while delivering 1,000-fold
less protein per dose
Rehovot, Israel, 4 June 2003 - XTL Biopharmaceuticals Ltd. (XTLbio) reported
today results from a pharmacokinetics (PK) study of the absorption,
distribution, metabolism and excretion of HepeX-B, a therapeutic being
developed to prevent re-infection by the hepatitis B virus (HBV) in
transplanted livers. In the PK study, conducted in the UK between January and
May of 2003, 12 healthy volunteers randomly received a single, intravenous
infusion of 10 mg or 40 mg of HepeX-B. No serious adverse events were reported
by any of the volunteers.
The average maximum serum concentrations of anti-HBV antibody obtained after a
single 10 mg dose of HepeX-B was more than 3,500 mIU/mL, similar to levels
typically obtained following the administration of a 10,000 IU* dose of the
polyclonal hepatitis B immune globulin (HBIg) solution, currently the standard
of care in HBV-related liver transplant prophylaxis treatment. A single 40 mg
dose of HepeX-B produced an average maximum serum concentration 4 to 5 times
greater than that achieved with the standard 10,000 IU* dose of the polyclonal
alternative. (*1 IU = 1 mg for HBIg)
Phase 2 clinical trials of HepeX-B on HBV-related liver transplant patients are
scheduled to commence during 2003.
"The results of this study are encouraging and support the continued
development of HepeX-B," said XTLbio Chief Medical Officer, Neil Graham, MD.
"If our drug candidate can achieve the same or greater antibody levels as
today's first-line treatment while delivering 1,000-fold less protein, the
results could mean less expensive treatments, fewer side effects and simpler
modes of administration."
About XTLbio
XTL Biopharmaceuticals Ltd. (XTLbio) is the drug development company committed
to conquering hepatitis C in our time. XTLbio's HepeX(tm) product line - now in
clinical trials - has the potential to introduce revolutionary therapies for
viral hepatitis, including prevention of re-infection in transplanted livers,
the Company's primary focus, and a longer-term cocktail approach in treating
chronic illness. XTLbio believes its primary competitive advantage lies in its
patented Trimera(tm) technology, which enables the development of fully human
monoclonal antibodies and models of human disease for pre-clinical drug
validation. Established in 1993, XTLbio became a public company in 2000 with
shares traded on the London Stock Exchange under the symbol XTL.
About hepatitis C
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 (HCV) and that 3 to 4 million people are newly infected each
year. It is expected that 25 to 35% of these chronic patients will develop
progressive liver disease including cirrhosis and liver cancer. Hepatitis C is
the single leading cause of liver transplantation. The US Centers for Disease
Control and Prevention estimate that approximately 4 million people in the
United States (almost 2% of the population) have been infected with HCV, of
whom, approximately 3 million are chronically ill. Hepatitis C is the cause of
an estimated 8,000 to 10,000 deaths annually in the US.
About HCV-related liver transplant prophylaxis
Approximately 5% of chronic HCV patients will develop end-stage liver disease,
and ultimately may require liver transplantation. Today, there is a major
problem associated with HCV-related liver transplantation. Although the
infected liver - the major source of viral replication - has been removed,
free-floating virus in the patient's serum re-infects the healthy transplanted
liver in a matter of weeks. Disease progression in re-infected patients is
several times faster and, in many cases, a re-transplant becomes necessary. At
present, there is no available solution to this problem. The Company estimates
worldwide annual sales potential for HCV liver transplant prophylaxis at US$400
million.
About the treatment of chronic hepatitis C
The existing first-line chronic HCV therapy is often associated with a 50-60%
chance of success but is limited by severe side effects, including anaemia,
fatigue, hair loss and depression. Due to the relatively limited efficacy and
toxicity of this treatment, chronic HCV is still considered an unmet medical
need. Financial analysts estimate that worldwide annual sales for all products
treating chronic hepatitis C could reach US$4 billion in 2004.
HepeX(tm), Trimera(tm), XTL(tm) and XTLbio(tm) are trademarks of XTL Biopharmaceuticals
Ltd.
Contacts:
XTLbio
Dr. Martin Becker, President and CEO, Tel: +972-8-930-4440
Financial Dynamics
David Yates, Sarah MacLeod, Tel: +44 (0) 20 7831 3113
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