XTL Biopharmaceuticals Ltd
18 November 2004
XTL Biopharmaceuticals Ltd Reports Progress in HepeX-C Program
Rehovot, Israel, 18 November 2004: XTL Biopharmaceuticals Ltd. (LSE: XTL)
('XTLbio' or the 'Company') reports progress in developing HepeX-C as a
combination of two human monoclonal antibodies (MAb's) for prevention of
re-infection with HCV following liver transplantation (LT):
* FDA formally releases clinical hold on Phase 2a trial with single MAb
* Following analysis of results available from the above trial, XTLbio can
now estimate target dosing regimen range required to achieve a therapeutic
effect in LT patients without the need to continue this trial; and
* Following a positive Pre-IND meeting with FDA, XTLbio to file an IND for
HepeX-C as a dual MAb product in the first half of 2005.
The Company has received notification from the FDA that the phase 2a trial with
AbXTL68 is formally off clinical hold. XTLbio has now completed analysis of the
first 5 cohorts of this trial. This analysis has enabled XTLbio to estimate the
target dosing regimen required for a therapeutic effect in liver transplant
patients and therefore no further patient recruitment is necessary. This
information has already been incorporated in the design of upcoming studies with
The first part of HepeX-C's development strategy was evaluation of a single
antibody (AbXTL68) in patients with chronic HCV and in liver transplant
patients. These 2 trials have evaluated safety, antiviral and pharmacokinetic
properties of AbXTL68 and have allowed the Company to estimate the target dose /
frequency range required for a therapeutic effect in liver transplant patients.
This information is critical for the design of the second part of HepeX-C's
development strategy - evaluation of the dual-MAb product in clinical trials.
Based on this the Company had a pre-IND meeting with the FDA at which XTLbio
presented data on AbXTL68 and AbXTL65 which has just successfully completed
pre-clinical development. XTLbio also presented the rationale for developing
HepeX-C as a combination product containing AbXTL68 and AbXTL65 (targeting
different viral sites). Similar drug combination approaches are currently
employed in treatment of other viral diseases. XTLbio's HepeX-B, currently in
Phase 2b for preventing re-infection with HBV in liver transplant patients, is
also a dual-MAb product.
The clinical trial design discussed with FDA includes a dose escalating study
with HepeX-C in patients with chronic HCV to evaluate safety and biological
activity of the drug. This study will be followed by a trial in liver transplant
patients. XTLbio is now preparing an IND for the dual-MAb product for submission
to the FDA in the first half of 2005.
'The studies we have conducted to date with AbXTL68 as a single agent provided
us with preliminary indication of safety and antiviral activity of AbXTL68, and
enabled us to estimate the target therapeutic dose / frequency range in liver
transplant patients. We are now applying the information gathered in these
trials to the development of HepeX-C as a dual-antibody product. We are excited
to move forward rapidly with the development of HepeX-C' said Dr. Neil Graham,
XTLbio's Chief Medical Officer.
Dr. Neil Graham, Chief Medical Officer Tel: +1 919 806 4623
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.
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.
HepeXTM, TrimeraTM, XTLTM and XTLbioTM are trademarks of XTL Biopharmaceuticals
This information is provided by RNS
The company news service from the London Stock Exchange