ID Biomedical Announces Immunogenicity Results from Phase II Trial of Streptavax
26 1월 2005 - 11:15PM
PR Newswire (US)
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, ; To request a free copy of this
organization's annual report, please go to http://www.newswire.ca/
and click on reports@cnw.
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