ID Biomedical's strep vaccine a
success in early human study
TRADING SYMBOLS - NASDAQ - ''IDBE'', TSE -
''IDB''
VANCOUVER, Feb. 9 /CNW-PRN/ - ID Biomedical
Corporation
(NASDAQ:IDBE - news; TSE:IDB - news) announced
today that results from
human testing of its group A streptococcus vaccine,
StreptAvax(TM), indicate the
vaccine at the 50ug dose is safe and well tolerated. The
US Food and Drug
Administration (FDA) has determined that
StreptAvax(TM) may proceed in
human testing at a higher dose.
Group A streptococcus is responsible for common
infections of the throat (''strep
throat'') and skin. Left untreated, these infections can
lead to life threatening
diseases including invasive faciitis (''flesh eating
disease''), rheumatic fever and
toxic shock syndrome. In the United States alone it is
estimated that there are
25-35 million doctor visits each year for suspected group
A streptococcal
infections, making it one of the most common childhood
illnesses for which no
preventative vaccine exists.
StreptAvax(TM) is the only group A strep vaccine
currently in human testing in
the United States and is believed to be the only group A
strep vaccine that the
FDA has cleared for clinical trials in over two decades.
ID Biomedical holds an
exclusive worldwide license to the StreptAvax(TM)
technology.
''Because of the prevalence of group A strep infections
and the serious associated
sequelae, we believe that a safe and effective vaccine
will be a strong candidate
for routine use in children worldwide,'' stated Anthony
Holler, President of ID
Biomedical.
This study, sponsored and funded by the National
Institute of Allergy and
Infectious Diseases, a division of the National Institutes
of Health (NIH), is being
carried out at the University of Maryland School of
Medicine's Center for Vaccine
Development. Dr. Karen Kotloff, Professor of Pediatrics
and Medicine, is the
Principal Investigator.
In this initial cohort of the Phase I testing that was just
completed, all subjects
developed antibody responses to the vaccine. The
development of an antibody
response is a prerequisite for StreptAvax(TM) to prevent
diseases caused by group
A streptococcus.
''Safety is the primary endpoint of this study and the
vaccine was safe and well
tolerated by the volunteers,'' said Dr. James Dale, the
original inventor of the
vaccine from the University of Tennessee College of
Medicine and the Veterans
Affairs Medical Center. ''Additionally, it is very
encouraging that all of the
volunteers developed antibodies at this low dose and
none of these antibodies
cross-reacts with human tissues.''
The protocol of the Phase I study calls for
StreptAvax(TM) to be given to three
groups of human volunteers starting with the lowest
dose and proceeding to two
higher doses.
''Group A strep is an important cause of illness
throughout the world. Each year
in the US alone, there are millions of GAS infections,
mostly from sore throats
and skin infections. These infections occasionally lead to
serious complications,
including rheumatic fever. In developing countries,
rheumatic fever is the leading
cause of heart disease among children,'' said Dr. Kotloff,
Professor of Pediatrics
and Medicine. ''A safe and effective vaccine that could
prevent group A strep
infection and its sequelae would thus be a major public
health contribution.''
ID Biomedical's GAS vaccine is a subunit vaccine made
from the terminal
fragments of the surface M protein. It is well established
that the M protein of
group A streptococci is the major protective antigen,
making it an ideal target for
vaccine development. The prototypic vaccine currently
being tested is designed to
produce a preventative immune response against six
different strains of group A
streptococcus.
ID Biomedical's scientific team, in collaboration with Dr.
Dale, has now cloned
protective antigens from 26 distinct strains of GAS,
potentially creating a vaccine
with broad coverage. Using the latest US data from the
Centers for Disease
Control and Prevention, the 26 valent vaccine would
cover greater than 90% of
pharyngitis (''strep throat'') and greater than 95% of
invasive GAS diseases,
including rheumatic fever, invasive fasciitis and toxic
shock syndrome.
ID Biomedical Corporation is a North American based
biopharmaceutical
company focussed on the development of proprietary
vaccine and
immumotherapeutic products. The Company's lead
product, a vaccine for the
prevention of group A streptococcal diseases,
StreptAvax(TM), is in a Phase I
Clinical Trial sponsored by the National Institute of
Allergy and Infectious
Diseases. Other vaccine products under development
include: a vaccine for the
prevention of tuberculosis which has been licensed to
Aventis Pasteur, the vaccine
subsidiary of Aventis S.A (formally
Rhone-Poulanc/Hoechst), a therapeutic
vaccine for the prevention of AIDS and a vaccine for the
prevention of disease
caused by deadly strains of the E. coli bacteria. ID
Biomedical also has a division
that is developing tests to detect antibiotic resistant
organisms from culture, based
on the Company's core gene-detection system known as
Cycling Probe(TM)
Technology.
The foregoing information includes forward-looking
statements concerning,
among other things, management's plans and objectives
for future corporate
objectives, possible product launch and possible
revenues. All such
forward-looking statements are, by necessity, only
estimates or expectations of
future results and actual results achieved by the
Company may differ materially
from these statements due to a number of factors,
including i) the Company's
ability to successfully complete preclinical development
and manufacturing and
obtain timely regulatory approval, ii) decisions, and the
timing of decisions, made
by the health regulatory agencies regarding approval of
the Company's products
for human testing, iii) the willingness of other
companies to enter into agreements.
The Company assumes no obligation to update these
forward-looking statements
to reflect actual results, changes in assumptions or
changes in other factors
affecting such statements. |
