XTLbio Highlights Presence at The Liver Meeting
October 28 2003 - 2:02AM
UK Regulatory
XTLbio Highlights Presence at The Liver Meeting
HepeX Programs at 54th Annual AASLD include Poster Presentations,
Oral Presentation and Exhibitors Booth
Rehovot, Israel, 28 October 2003: XTL Biopharmaceuticals Ltd. (LSE:XTL)
provided details of key scientific presentations and data released at the 54th
Annual Meeting of The American Association for the Study of Liver Diseases,
October 24 - 28 in Boston, Massachusetts. AASLD - The Liver Meeting -is the
premier meeting in the science and practice of hepatology where the cutting
edge in the study and treatment of liver and biliary disease is defined.
Highlights of XTLbio's presentations included the following:
HCV Small Molecule Program - Second New Drug Candidate advances to preclinical
development
On Monday Oct 27, XTLbio's Chief Scientific Officer, Dr. Shlomo Dagan delivered
an Oral Presentation titled IN-VITRO AND IN-VIVO EVALUATION OF HCV POLYMERASE
INHIBITORS AS POTENTIAL DRUG CANDIDATES FOR TREATMENT OF CHRONIC HEPATITIS C
INFECTION. Dr. Dagan reported that the Company has now advanced to development
a small-molecule drug candidate developed to inhibit replication of the
hepatitis C virus (HCV). The molecule, one of a series of compounds licensed
exclusively to XTLbio, has recently shown good toxicity profiles in preliminary
testing, thus advancing it to the next level of pre-clinical development. As
previously announced, this family of HCV polymerase inhibitors exhibited
biological activity using XTLbio's proprietary HCV in vitro and in vivo
pre-clinical drug validation systems.
Dr. Dagan also reported that XTLbio's lead polymerase inhibitor remains on
track for an IND in 2004.
HepeX-C
Earlier this year XTLbio released preliminary data regarding from its Phase 1b
HepeX-C study. Poster Number 758: CLINICAL EVALUATION OF A HUMAN MONOCLONAL
ANTIBODY AGAINST THE ENVELOPE PROTEIN (E2) OF HCV FOR PREVENTION OF HCV
INFECTION summarized the final study results and confirmed the clinical
activity of HepeX-C in chronic patients. Over 70% (18/25) of the patients, had
a greater than 80% decrease in HCV viral load observed at least once following
infusion, and one-third of the patients showed a drop of between 1 log and 2.5
logs at least once following infusion. HepeX-C continues to be well tolerated
with no drug related serious adverse effects.
HepeX-B
During 2002, XTL released interim results from Phase 2a trial with HepeX-B and
lamivudine in patients with chronic HBV. Poster Presentation 781: PHASE 2
CLINICAL STUDY EVALUATING SAFETY AND EFFICACY OF HEPEX-B, A MIXTURE OF TWO
HUMAN MONOCLONAL ANTIBODIES TO HBsAg IN COMBINATION WITH LAMIVUDINE IN CHRONIC
HBV PATIENTS reviewed the complete data set from 60 patients, who were treated
for periods up to one year. HepeX-B was well tolerated and HBsAg levels were
consistently reduced across all patients and administrations. In some patients,
when HepeX-B was administered at a sufficient dose and frequency to accomplish
antibody excess - HBsAg was continuously suppressed for prolonged periods - up
to one year.
Additionally, Poster 1773: Viral Dynamics Modeling Indicates that THE MAJOR
Mechanism of Action of HepeX-B against Hepatitis B Virus is Acceleration of the
Free Virus Clearance was submitted by Prof. Avidan Neumann of Bar Ilan
University in collaboration with XTLbio. The poster provided added evidence to
support using HepeX-B to rapidly clear the virus in patients.
Contacts:
XTLbio
Dr. Martin Becker, President and CEO, Tel: +972-8-930-4440
Glenn Kazo, CBO, Tel: +1-603-878-9857
Financial Dynamics
David Yates, Sarah MacLeod, Tel: +44 (0) 20 7831 3113
About XTLbio
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 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.
About the treatment of chronic hepatitis C
The existing first-line chronic HCV therapy is often associated with a 50-60%
success rate but it 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 to be an unmet
medical need, with estimated worldwide annual sales for all products treating
chronic hepatitis C reaching US$4 billion in 2004.
HepeX(tm), Trimera(tm), XTL(tm) and XTLbio(tm) are trademarks of XTL Biopharmaceuticals
Ltd.
END