XTL Biopharmaceuticals Limited
16 December 2003
XTLbio R&D and Business Development Update
Rehovot, Israel, 16 December 2003 - XTL Biopharmaceuticals Ltd (XTLbio) today
announces an update on recent clinical progress and corporate developments to
investors and analysts.
- Phase 2 trial initiated with HepeX(TM)-B in hepatitis B patients for the
prevention of infection following liver transplant
- Interim clinical results for HepeX(TM)-C dose escalation trial
- Progress in discussions on HepeX(TM) corporate alliances
HepeX(TM)-B Update: dosing commenced in Phase 2b trial
XTLbio has commenced dosing in a Phase 2b trial with HepeX-B for the prevention
of re-infection in hepatitis B patients following liver transplant.
The trial is being conducted in the US, Europe and Israel and involves 45
patients. Patients receiving the current first-line preventative treatment,
blood derived polyclonal hepatitis B immune globulin (HBIg) solution together
with lamivudine, will be randomised to three cohorts; one cohort continuing on
the standard preventative treatment and two cohorts receiving different doses of
HepeX-B together with lamivudine. The goal of the study is to demonstrate that
replacement of HBIg with HepeX-B in the current prophylaxis protocol in HBV
liver transplant patients is effective in preventing HBV re-infection. Patients
will be treated over a six-month period, with a 12-month follow-on observation
period. Primary endpoints will be HBV DNA and HBV antigen levels. Secondary
endpoints will be anti-HBV antibody blood levels and the safety of HepeX-B
compared to the current drug.
HepeX-B is a combination of two fully human monoclonal antibodies acting on the
hepatitis B virus surface antigen, which were selected based on their strong
activity against the virus in XTLbio's pre-clinical Trimera(TM) model. In a
recently reported study, HepeX-B maintained serum levels similar to or higher
than the current first-line treatment (HBIg), while using 1,000 times less drug.
In August this year, HepeX-B was granted Orphan Drug Designation from the US
Food and Drug Administration, giving the product exclusive marketing rights in
the US for seven years following marketing approval.
Dr Neil Graham, Chief Medical Officer of XTLbio, said:
'Chronic hepatitis B is the most common serious liver infection in the world and
can be fatal for patients whose disease progression necessitates a liver
transplant. In the phase 2 trial announced today, we hope to be able to confirm
the beneficial effects of HepeX-B seen in earlier studies and show a meaningful
benefit to patients who have undergone liver transplant.'
HepeX(TM)-C Update: Interim clinical results from dose escalation trial
XTLbio discloses preliminary clinical results from its Phase 2a randomised
placebo controlled dose-escalation / safety study on HepeX-C. The interim
results involved 12 HCV associated liver transplant patients who received the
low dose regimens of HepeX-C for three months after their transplants.
Based on the absence of drug related severe adverse events on these initial
twelve patients together with amendments to include additional cohorts, the FDA
has permitted the higher dosing regimen. XTLbio is now proceeding with
completing the higher dose cohorts in the 24 patient study.
HepeX-C is a fully human high-affinity monoclonal antibody, which was shown to
reduce viral levels of the HCV virus in chronic HCV patients in a Phase 1b dose
ranging safety study. Based upon safety data generated in that study, XTLbio
decided to clinically evaluate HepeX-C in liver transplant patients infected
with HCV. The study is aimed at achieving the minimum dose necessary of HepeX-C
to bind all free HCV virus in the blood stream and thereby prevent or delay
re-infection of the transplanted liver with HCV, known as 'antibody excess'. It
is believed antibody excess could potentially prevent or significantly delay
re-infection of patients with HCV after their transplant. The continuation of
the dose escalation study in 12 additional patients is designed to find the
minimum dose necessary to achieve antibody excess while demonstrating safety.
Dr. Shlomo Dagan, XTLbio's Chief Scientific Officer, stated:
'As reported at the recent AASLD liver meeting in Boston, one of the most
critical needs for liver transplant specialists today is to find an approach to
limit the devastating effects of HCV re-infection. The prognosis for such
patients begs for a solution. Our strategy to achieve antibody excess is fully
justified based upon our review of the data. Therefore we look forward to
completing this trial in HepeX-C in transplant recipients.'
Business Development Update
XTLbio is making progress to secure an alliance on our HepeX programs. Securing
a partner for one or more of our products remains the key priority for XTLbio.
Glenn Kazo, Chief Business Officer of XTLbio, said:
'We are encouraged by the high level of interest shown in our pipeline and are
in discussions of various stages with a number of potential partners. It is our
intention to conclude a value enhancing partnership at the earliest possible
opportunity and we are working continuously to achieve this.'
Dr. Martin Becker, President and CEO, Tel: +972-8-930-4440
Glenn Kazo, CBO, Tel: +1-603-878-9857
David Yates, Sarah MacLeod, Tel: +44 (0) 20 7831 3113
Notes to Editors
XTL Biopharmaceuticals Ltd. (XTLbio) is a biopharmaceutical company developing
drugs against hepatitis. 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 HBV-related liver transplant prophylaxis
Hepatitis B is the most common form of hepatitis and one of the world's leading
causes of death. About 5% of chronic hepatitis B patients will develop end-stage
liver disease, a condition, which necessitates liver transplantation. During the
liver transplantation procedure the diseased liver is removed and a healthy
liver from a donor is transplanted. Without proper treatment, the newly
transplanted liver can become re-infected by residual virus in the patient's
serum, leading to rapid disease progression and graft failure in many cases. The
current market for prevention of hepatitis B infection following liver
transplant is estimated to be worth $100 million.
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 Centres 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
This information is provided by RNS
The company news service from the London Stock Exchange