XTL Biopharmaceuticals Ltd
23 November 2004
Cubist Pharmaceuticals and XTL Biopharmaceuticals Announce Completion of
Independent Data and Safety Monitoring Board (DSMB) Review of Phase 2 Data for
DSMB Recommends Continuation of Trial
Cubist Pharmaceuticals, Inc. (Nasdaq: CBST) and XTL Biopharmaceuticals Ltd.
(LSE:XTL) today announced the completion of the first scheduled review by an
independent data and safety monitoring board (DSMB) of the first group of 15
patients enrolled in the ongoing Phase 2 clinical trial. The trial is the second
of two planned Phase 2 trials. This study is examining the safety and efficacy
of HepeX-B (libivirumab and exbivirumab for injection) for prevention of
hepatitis B reinfection in patients who have received liver transplantation for
end-stage hepatitis B infection, and who have been maintained on hepatitis B
immune globulin (HBIg).
The clinical protocol for an open-label study of HepeX-B was designed with input
from the U.S. Food & Drug Administration (FDA) and specifies for periodic
scheduled open-label reviews of the clinical data by an independent DSMB. Based
upon a review of the data provided by XTL, the DSMB, convened by Duke Clinical
Research Institute at Duke University, has recommended continuation of the
trial. Patients are currently being enrolled in the trial in the U.S. and in
Israel. Centres in several Western European countries will be opened shortly.
Dr. Martin Becker, President and CEO Tel: +1 617 621 1570
Julia Phillips, James Strong Tel: +44 (0) 20 7831 3113
Notes to Editor
XTL Biopharmaceuticals Ltd. (XTLbio) is a biopharmaceutical company developing
drugs against hepatitis. XTLbio's HepeXTM 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 TrimeraTM
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 and its shares are listed on the
Official List of the UK Listing Authority and are traded on the London Stock
Exchange under the symbol XTL.
Hepatitis B is most commonly caused by the Hepatitis B virus, which, according
to Datamonitor, has infected over 2 billion people around the world. Although a
vaccine against HBV was introduced in 1982, globally, 350 million people are
infected chronically with the disease and approximately 1 million people die
each year as a result of complications from HBV infection. Current treatment
regimens for chronic HBV often include use of interferon alpha or an antiviral
drug. Despite these treatment options, chronic HBV can lead to severe liver
damage and patients may require liver transplantation To prevent re-infection of
the new liver with HBV, patients are currently treated with hepatitis B immune
globulin (HBIg) combined with an antiviral compound, such as lamivudine. The
global market for HBIg is estimated to be about $100 million annually.
HepeX-BTM is a combination of two fully human monoclonal antibodies, selected
using XTLbio's pre-clinical TrimeraTM model, that target HBV surface antigens.
It is currently in an international Phase 2 study for the prevention of
infection by HBV in liver transplant patients who have been maintained on HBIg.
In clinical studies, HepeX-BTM maintained serum levels similar to or higher than
the current first-line treatment, HBIg, using 1,000 times less drug. HepeX-BTM
has already been granted Orphan Drug Status in both the U.S. and the European
HepeXTM, TrimeraTM, XTLTM and XTLbioTM are trademarks of XTL Biopharmaceuticals
This information is provided by RNS
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