XTLbio Announces Data Demonstrating the Antiviral Activity of One of the Two Antibodies Comprising XTLbio's Lead Hepatitis C Dru
16 November 2005 - 7:26PM
PR Newswire (US)
Data Presented Yesterday at the 56th Annual Meeting of the American
Association for the Study of Liver Diseases in San Francisco
REHOVOT, Israel, November 16 /PRNewswire-FirstCall/ -- XTL
Biopharmaceuticals Ltd. ("XTLbio") (LSE:XTL)(NASDAQ:XTLB)(TASE:XTL)
presented yesterday data from a pilot Phase I/II clinical trial
with Ab68, one of the two antibodies comprising XTLbio's lead
Hepatitis C drug candidate - XTL-6865. This pilot study was
conducted in patients with hepatitis C following liver
transplantation. Patients in this study were treated with 20, 40,
80, 120 or 240 mg doses of Ab68. Ab68 was administered once during
the transplantation, then up to 3 times during the first 24 hours
following the transplantation, then daily during the following 6
days, and then in a decreasing frequency during the following 11
weeks. During the period of daily dosing (the first 7 days
following the transplantation) reduction in viral load from
baseline was greater in the two highest dose groups (120 and 240
mg) compared to the placebo group. On day 1 following the
transplantation (when Ab68 was administered 3 times) the median
reduction in viral load from baseline of the highest dose group
(240 mg) was 1-log (90%) greater than the placebo group. Thomas
Schiano, MD, Medical Director of Adult Liver Transplantation and
Director of Clinical Hepatology at the Recanati/Miller
Transplantation Institute at Mount Sinai Medical Center commented:
"The results presented are very encouraging, as they provide
clinical demonstration that Ab68 - which is one of the two
antibodies comprising XTLbio's lead hepatitis C drug candidate -
XTL-6865 - has shown activity in reducing viral levels." The dual
antibody product - XTL-6865 - is presently in Phase Ia clinical
trial in patients with chronic hepatitis C. Results from this trial
are expected in the second half of 2006 Link to the data
presentation: http://www.xtlbio.com/ About XTL-6865 XTL-6865 is
XTLbio's lead Hepatitis C drug candidate, currently in a Phase Ia
clinical trial in patients with chronic hepatitis C. XTL-6865 is a
dual-antibody therapeutic developed for two potential indications:
preventing hepatitis C recurrence following liver transplantation
and preventing relapse following treatment of patients with chronic
Hepatitis C. The two antibodies comprising XTL-6865 - Ab68 and Ab65
- were developed sequentially, and Ab68 was available for clinical
evaluation approximately 2 years before Ab65. This enabled XTLbio
to conduct pilot studies with Ab68 alone to evaluate its safety and
pharmacokinetic properties in patients with chronic hepatitis C,
and in patients with hepatitis C following liver transplantation.
The pilot studies with Ab68 in patients with chronic hepatitis C
provided preliminary evidence of antiviral activity of Ab68. In the
multi-dose pilot study in patients with chronic hepatitis C, a
third of the patients demonstrated at least once an equal to or
greater than 1-log (90%) reduction in viral load following the
administration of Ab68. The pilot study in patients following liver
transplantation - the results of which are described above -
provided further data demonstrating the antiviral activity of Ab68.
Phase 1a trial with the dual antibody drug candidate - XTL-6865 -
was initiated in September 2005 in patients with chronic hepatitis
C. Results from this trial are expected in the second half of 2006.
Contacts: XTLbio Jonathan Burgin, Chief Financial Officer Tel:
+972-8-930-4440 About XTL Biopharmaceuticals Ltd. Established in
1993, XTL Biopharmaceuticals Ltd. (LSE:XTL)(NASDAQ:XTLB) ( TASE:
XTL) is a biopharmaceutical company engaged in the acquisition,
development and commercialization of pharmaceutical products for
the treatment of infectious diseases, particularly the prevention
and treatment of hepatitis B and C. Cautionary Statement Some of
the statements included in this press release may be
forward-looking statements that involve a number of risks and
uncertainties. For those statements, we claim the protection of the
safe harbor for forward-looking statements contained in the US
Private Securities Litigation Reform Act of 1995. Among the factors
that could cause our actual results to differ materially, and
therefore affect interest by investors in our securities, are the
following: the results of the trials of Ab68 are not necessarily
indicative of the results we may have in future trials of the Ab68
antibody or of the Phase 1a and 1b trials of XTL6865, as there are
many factors affecting those future studies that could yield more
inconclusive or negative results; and other risk factors identified
from time to time in our reports filed with the various regulatory
bodies. Any forward-looking statements set forth in this press
release speak only as of the date of this press release. We do not
intend to update any of these forward-looking statements to reflect
events or circumstances that occur after the date hereof. This
press release and prior releases are available at
http://www.xtlbio.com/. The information in our website is not
incorporated by reference into this press release and is included
as an inactive textual reference only. DATASOURCE: XTL
Biopharmaceuticals Ltd. CONTACT: Contacts: XTLbio, Jonathan Burgin,
Chief Financial Officer Tel: +972-8-930-4440
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