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happens it is sometimes a good indication for the
stock.Just my thoughts. "
Look!...Well they got a few off me but I got lots left!
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.
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