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Monday January 8, 9:30 am Eastern Time
Press Release
SOURCE: ID Biomedical Corporation
ID Biomedical files application to
advance StreptAvax(TM) into next
stage of human testing
Group A Streptococcus Vaccine Expected to Begin Testing in
Children
TRADING SYMBOLS - NASDAQ - "IDBE", TSE - "IDB"
VANCOUVER, Jan. 8 /PRNewswire/ - ID Biomedical Corporation announced
today that it has filed an application with the Canadian Health Protection Branch,
to conduct a Phase I/II Clinical Trial of its lead vaccine product, StreptAvax(TM).
StreptAvax(TM) is a multivalent recombinant vaccine developed to cover 26
serotypes of group A streptococcus. According to the US Centers for Disease
Control and Prevention (CDC) these serotypes are believed to be responsible for
causing the vast majority of group A streptococcus related diseases.
The proposed Clinical Trial will initially evaluate the safety of StreptAvax(TM) in
a small group of adults. With positive results, the studies will move to a Phase II
Clinical Trial to examine the safety and immune response of the vaccine in
children. In this portion of the Clinical Trial, ID Biomedical expects children of
two different age groups to receive StreptAvax(TM): adolescents, age 10-14 years
of age; and the target age group for which StreptAvax(TM) is being primarily
developed, preschool children, 3-6 years of age.
``Children get repeated strep throat infections and, left untreated, they can get life
threatening illnesses. Modern biotechnology has allowed us to develop a
potentially safe and effective vaccine for this common cause of illness,''
commented Anthony Holler, M.D., President of ID Biomedical. ``At the end of
this Phase II study, we will have safety and immune response data in the primary
target population. This data, if positive, will give our Company a number of
options for proceeding to Phase III Clinical Trials of StreptAvax(TM).''
A prototype of StreptAvax(TM) which covers 6 common serotypes of group A
streptococcus is being tested at the University of Maryland, Center for Vaccine
Development. This study, sponsored and funded by the National Institute of
Allergy and Infectious Disease, has proven that the prototypic vaccine at a dose of
50ug is safe and well tolerated and that all of the human subjects developed an
antibody response to the vaccine, which is a prerequisite if StreptAvax(TM) is to
prevent diseases caused by group A streptococcus. Currently, the prototypic
vaccine is being tested at a dose of 100ug in healthy adult volunteers. To date, no
safety concerns or material adverse events have been reported.
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.
The prototypic StreptAvax(TM) is the only group A streptococcus vaccine
currently in human testing in the United States and is believed to be the only group
A streptococcal vaccine that the FDA has cleared for clinical trials in over two
decades. With the expanded version of StreptAvax(TM) moving to advanced
human testing, the Company further extends its leadership position in the
development of a group A streptococcus vaccine. ID Biomedical holds an
exclusive worldwide license to the StreptAvax(TM) technology from the
University of Tennessee Research Corporation.
About ID Biomedical
ID Biomedical Corporation is a North American based biotechnology company
focused on the development of proprietary vaccine and immunotherapeutic
products, and is also focused on the development of a proprietary gene
identification system, Cycling Probe(TM) Technology, for applications in
genomics and diagnostics.
ID Biomedical is developing vaccines for a number of different conditions. The
Company's lead vaccine product for the prevention of diseases caused by group A
streptococcus, StreptAvax(TM), is in a Phase I Clinical Trial sponsored and
funded 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, 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.
Using Cycling Probe(TM) Technology, ID Biomedical is developing rapid tests
that identify antibiotic resistant bacteria from culture. ID Biomedical is now
licensing Cycling Probe(TM) Technology as well as its broad patents in signal
amplification to the genomics and diagnostic industry for further product and
technology development.
Currently, Applied Biosystems, Mitsubishi Chemical Corporation, Alexon- Trend,
a subsidiary of Sybron International, DiscoveRx, and Third Wave Technologies
have obtained rights to IDB's patents.
The foregoing information contains so-called forward-looking statements. These
include statements about ID Biomedical's expectations, beliefs, intentions or
strategies for the future, which it indicates by words or phrases such as
``anticipate'', ``expect'', ``intend'', ``plan'', ``will'', ``we believe'', ``ID Biomedical
believes'', ``management believes'' and similar language. All forward-looking
statements are based on ID Biomedical's current expectations and are subject to
risks uncertainties and to assumptions made. Important factors that could cause
actual results to differ materially from those expressed or implied by such
forward-looking statements include: (i) the ability to successfully complete
preclinical and clinical development of its products; ii) the ability to obtain and
enforce timely patent and intellectual property protection for its technology and
products; iii) the ability to avoid, either by product design, licensing arrangement
or otherwise, infringement of third parties' intellectual property; iv) decisions, and
the timing of decisions, made by the health regulatory agencies regarding approval
of its products for human testing; v) the ability to complete and maintain corporate
alliances relating to the development and commercialization of its technology and
products, vi) market acceptance of its technology and products, and (vii) the
competitive environment and impact of technological change. ID Biomedical
bases its forward-looking statements on information currently available to it, and
assumes no obligation to update them.
SOURCE: ID Biomedical Corporation |
