ID Biomedical (NASDAQ:IDBE)
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ID Biomedical Announces Immunogenicity Results from Phase II
Trial of Streptavax
VANCOUVER, Jan. 26 /PRNewswire-FirstCall/ -- ID Biomedical Corporation (TSX:
IDB; NASDAQ: IDBE) announced today that it has completed its final analysis of
immune responses of adults in its Phase II trial of StreptAvax(TM) vaccine, the
Company's subunit protein-based vaccine against group A streptococcal diseases.
The trial enrolled 90 healthy adult subjects, 70 of whom received StreptAvax
and 20 of whom received hepatitis A vaccine as a comparator. All subjects
received three doses of vaccine, and serum antibody responses were measured
after the third dose.
StreptAvax is designed to induce protective immune responses to 26 different M
protein serotypes of group A streptococci which are responsible for causing the
vast majority of disease, including the types that are the most common causes
of "strep throat" and invasive infections (so-called "flesh-eating disease") in
North America as well as the types historically associated with the most feared
complication of strep throat - acute rheumatic fever. In addition, the vaccine
also includes a 27th peptide derived from another protein, called Spa, which is
expressed by many important pathogenic strains of streptococci.
The results reported today show that, among the 70 subjects who received
StreptAvax, there was a statistically significant (p less than 0.0001) increase
in serum antibodies to every one of the 26 M protein serotypes, and to the Spa
protein. The average increase in antibody levels across the population of
StreptAvax recipients was 11.3 fold for each vaccine peptide. Viewed as
individuals, StreptAvax recipients responded to a median of 25 (91%) of the
different streptococcal peptides in the vaccine, and each peptide elicited a
significant immune response in a median of 87% of vaccinees. By way of
contrast, the group of 20 subjects who received hepatitis A vaccine had no
significant antibody increase against any of the streptococcal peptides.
The pattern of overall safety established in the Phase I trial continued in
this study.
"These new data confirm both the impressive strength and breadth of the immune
response and are consistent with our Phase I data. Additionally, StreptAvax
continues to have a relatively benign safety profile. The strong and consistent
antibody response data, combined with the absence of significant safety
findings, will lend strong support to the entry of StreptAvax into pediatric
populations," said Louis Fries, M.D., Vice President of Clinical Affairs for ID
Biomedical.
Over the past year, ID Biomedical has made preparations for StreptAvax clinical
testing in pediatric populations. ID Biomedical has developed a unique database
of the normal variation of echocardiograms over time in healthy children, which
will allow this diagnostic test to be used accurately as a safety monitoring
tool in pediatric subjects. In addition, the Company has developed and
qualified a new quantitative immunoassay method for group A streptococcal
antibodies for the volumes of serum available from small children.
The Company expects the final one-year safety analysis on all adult data, as
well as manufacturing data from additional production runs, to be ready toward
the end of the first quarter in support of a pre-IND meeting with the FDA
focusing on pediatric trials strategy. The Company plans to begin Phase II
pediatric clinical testing later in 2005. This initial study is expected to
include both dose-finding and age step-down components.
About Group A streptococcal infections
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 such as necrotizing fascitis ("flesh-eating disease")
and toxic shock syndrome. In addition, infections with group A streptococci can
trigger a variety of serious "post-streptococcal diseases," including rheumatic
fever, post-streptococcal glomerulonephritis (a form of kidney disease), and
neurologic abnormalities.
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.
About ID Biomedical
ID Biomedical is an integrated biotechnology company dedicated to the
development of innovative vaccine products. It operates in research,
development, manufacturing, sales and marketing from its facilities in Canada
and in the United States. ID Biomedical is dedicated to becoming a premier
vaccine company with significant marketed products worldwide and an extensive
pipeline in both clinical and preclinical development.
ID Biomedical has a leading position in the Canadian influenza market. It
received a ten-year mandate from the Government of Canada in 2001 to assure a
state of readiness in the case of an influenza pandemic and provide influenza
vaccine for all Canadians in such an event. It also currently supplies
approximately 75% of the Canadian government's influenza vaccine purchases.
For further information on ID Biomedical, please visit the Company's website at
http://www.idbiomedical.com/.
The information in this news release contains so-called "forward-looking"
statements. These include statements regarding ID Biomedical's expectations and
plans relating to the integration of the vaccine business acquired from Shire,
statements about ID Biomedical's expectations, beliefs, intentions or
strategies for the future, which may be indicated 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 and 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 company's ability to
successfully integrate the Shire vaccine business; (ii) the company's ability
to successfully complete preclinical and clinical development of its products;
(iii) the company's ability to manufacture its products; (iv) the seasonality
of the flu-vaccine business and related fluctuations in the company's revenues
from quarter to quarter; (v) decisions, and the timing of decisions, made by
the health regulatory agencies regarding approval of its products for human
testing; (vi) the company's ability to enter into distribution agreements for
its products, and to complete and maintain corporate alliances relating to the
development and commercialization of its technology and products; (vii) market
acceptance of its technologies and products; and (viii) the competitive
environment and impact of technological change and other risks detailed in the
company's filings with the Securities and Exchange Commission. ID Biomedical
bases its forward-looking statements on information currently available to it,
and assumes no obligation to update them.
For further information, please contact:
Investor Relations/Media
Dean Linden
(604) 431-9314
Michele Roy
(450) 978-6313
DATASOURCE: ID Biomedical Corporation
CONTACT: Investor Relations/Media, Dean Linden, (604) 431-9314,
; Michele Roy, (450) 978-6313,
;
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