Information  X 
Enter a valid email address

XTL Biopharm Ltd (XTL)

  Print      Mail a friend

Thursday 27 February, 2003

XTL Biopharm Ltd

XTLbio REPORTS CLINICAL PROOF OF PRINCIPLE FOR Hep


XTLbio REPORTS CLINICAL PROOF OF PRINCIPLE FOR HEPEX™-C AS POTENTIAL HEPATITIS
C VIRUS (HCV) PROPHYLACTIC ON POST LIVER TRANSPLANT PATIENTS

Good safety results and bioactivity seen in Phase 1 HepeX-C trials on chronic
HCV patients

Rehovot, Israel, 27 February 2002 - XTL Biopharmaceuticals Ltd. (XTLbio)
announced today clinical results from its Phase 1b dose-ranging/safety study on
HepeX-C involving 20 chronic HCV patients undergoing one month's treatment.

  * No drug-related significant adverse events were observed - good interim
    safety data provided to the US regulatory authorities allowed XTLbio to
    proceed with its Phase 2 study on post liver transplant patients.
   
  * Biological activity was confirmed - in 9 out of 20 patients a one-log
    (90%), or greater, reduction in viral load was seen at one or more dosing
    time points.
   
  * Data supports rationale for HepeX-C as an HCV prophylactic after a liver
    transplant, when the major source of viral replication has been removed.
   
'If HepeX-C is capable of preventing or delaying re-infection in patients
undergoing liver transplant, it could become a standard therapy. In this case,
annual sales potential of such a therapeutic could reach US$400 million,' said
Martin Becker, PhD, President and Chief Executive Officer of XTLbio. 'HCV
prophylaxis is also a more accessible niche for us, where we have the best
chance of taking a product all the way to market. In the United States 20
medical centres perform more than 50% of the transplants, with a similar
scenario in Europe.'

About XTLbio

XTL Biopharmaceuticals Ltd. (XTLbio) is the drug development company committed
to conquering hepatitis C in our time. XTLbio's HepeX™ 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™ 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™, Trimera™, XTL™ and XTLbio™ are trademarks of XTL Biopharmaceuticals
Ltd.

XTL Contact

Dr. Martin Becker, President and CEO, Tel: +972-8-930-4440