Cubist Pharmaceuticals Reports Results From Phase 2 Study Hepex-B(TM), Which Was Licensed From XTLbio
22 December 2005 - 6:50PM
PR Newswire (US)
REHOVOT, Israel, December 22 /PRNewswire-FirstCall/ -- XTL
Biopharmaceuticals Ltd. ("XTLbio") (LSE:XTL)(NASDAQ:XTLB)(TASE:XTL)
announces that Cubist Pharmaceuticals, Inc. (NASDAQ:CBST) today
provided data from a recently concluded Phase 2 study of
HepeX-B(TM) which was licensed to Cubist by XTLbio in 2004. In the
Phase 2 study, HepeX-B was studied as maintenance therapy to
prevent reinfection with hepatitis B in patients with liver
transplants. Data from liver transplant patients who were treated
with monthly infusions of 20 or 40 mg HepeX-B versus 5000 IU of
HBIg showed that patients with either dose of HepeX-B experienced
no evidence of viral reinfection. The data also showed fewer and
less serious adverse experiences reported in both HepeX-B groups as
compared to the HBIg group, although the differences were not
statistically significant given the number of patients in the
trial. Patients who were treated with HepeX-B as well as HBIg also
received concurrent HBV polymerase inhibitor. Cubist will be
reviewing Phase 2 results with the U.S. Food and Drug
Administration (FDA) early in 2006. The data released today is
derived from patients who have completed at least 6 months of
therapy, which was the treatment duration at which the primary
endpoint was measured. Eleven patients received monthly 20 mg
infusions of HepeX-B; ten received monthly infusions of 40 mg
HepeX-B; and nine received monthly infusions of 5000 IU HBIg
(current standard of care). Cubist recently met with the FDA to
discuss proposed changes to the method of manufacture and
formulation of HepeX-B. Specifically, Cubist plans to shift from
the use of hybridoma cells to Chinese Hamster Ovary (CHO) cells and
to switch to subcutaneous delivery prior to Phase 3. The objective
of the manufacturing change is to provide a stable platform for
commercialization. The switch to subcutaneous administration is
meant to increase patient convenience and compliance with chronic
therapy. Cubist will meet again with the FDA in early 2006 to
discuss the implications of these changes on the next stage of the
clinical program. Michael S. Weiss, Chairman of XTLbio, commented:
"We are very pleased with the results of this Phase 2 trial and the
fact that reinfection was not observed in any of the patients
treated with HepeX-B. We are proud of being responsible for
HepeX-B's discovery and early clinical development, and we are
pleased with the progress of this product towards commercialization
in the hands of our partner Cubist." About Hepatitis B (HBV) The
hepatitis B virus, according to Datamonitor, has infected more than
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. About HepeX-B(TM) HepeX-B is a combination
of two fully human monoclonal antibodies that target HBV surface
antigens. It is currently in evaluation for the prevention of
infection by HBV in liver transplant patients who have been
maintained on HBIg. HepeX-B already has been granted Orphan Drug
Status in both the U.S. and the European Union. About XTLbio XTL
Biopharmaceuticals Ltd (XTLbio) is engaged in the research,
development and commercialization of therapeutics for the treatment
of infectious diseases, with a particular focus on hepatitis C.
XTLbio's most advanced therapeutic in Hepatitis C is XTL-6865 - a
combination of two monoclonal antibodies against the hepatitis C
virus - presently in Phase 1 clinical trials in patients with
chronic hepatitis C. XTLbio's second Hepatitis C therapeutic is
XTL-2125 - a small molecule inhibitor of the hepatitis C Virus
polymerase - expected to enter Phase 1 clinical trials in 1H2006.
XTLbio hepatitis C pipeline also includes several families of
pre-clinical hepatitis C small molecule inhibitors. In 2004, XTLbio
licensed HepeX-B - an antibody therapeutic against hepatitis B - to
Cubist Pharmaceuticals. XTLbio is publicly traded on the London,
NASDAQ, and Tel-Aviv Stock Exchanges
(LSE:XTL)(NASDAQ:XTLB)(TASE:XTL). 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 U.S. 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 ADR's, are the following: the
performance of HepeX-B in further clinical trials and its ability
to continue to prevent reinfection following liver transplantation;
the effect of the proposed changes in the manufacture of HepeX-B on
its performance in clinical trials; Cubist's ability to shift the
manufacturing process for HepeX-B without causing a delay in
further clinical trials or ultimate commercialization; and other
risk factors identified from time to time in our reports filed with
the regulatory authorities in Israel, the United Kingdom and the
United States. 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. Contact XTLbio: Jonathan
Burgin, Chief Financial Officer, Tel: +972-8-930-4440 DATASOURCE:
XTL Biopharmaceuticals Ltd. CONTACT: Contact XTLbio: Jonathan
Burgin, Chief Financial Officer, Tel: +972-8-930-4440
Copyright
XTL Biopharmaceuticals (NASDAQ:XTLB)
Historical Stock Chart
From Jun 2024 to Jul 2024
XTL Biopharmaceuticals (NASDAQ:XTLB)
Historical Stock Chart
From Jul 2023 to Jul 2024