ID Biomedical receives positive data from clinical testing of its Group-Common Pneumococcal Vaccine
23 3월 2005 - 12:04AM
PR Newswire (US)
ID Biomedical receives positive data from clinical testing of its
Group-Common Pneumococcal Vaccine - Company receives clearance to
move testing of vaccine to infants VANCOUVER, March 22
/PRNewswire-FirstCall/ -- ID Biomedical Corporation (TSX: IDB;
NASDAQ: IDBE) announced today that it has completed analysis of
data obtained from several Phase 1 clinical studies of its
Pneumococcal Group- Common Vaccine, PGCvax(TM), in adults, elderly
and toddlers. PGCvax is being developed to prevent invasive
diseases, including meningitis, caused by the bacteria
Streptococcus pneumoniae (also known as the pneumococcus). These
studies enrolled over 300 subjects, who received the vaccine in a
series of four different clinical trials conducted in young adults,
the elderly, and toddlers in 2003 and 2004. The results
demonstrated that PGCvax was well-tolerated and immunogenic in
different age-groups. The 1-dose study in toddlers primarily
addressed safety, but the trials in adults included a 2-dose
regimen and yielded detailed immunogenicity data. Significant
(greater than four-fold) antibody responses to the protein antigen
in the vaccine were demonstrated in 92% of young adults and 85% of
elderly (65 years and over) subjects receiving optimal doses of the
vaccine, whereas no recipients of control products had such
responses. Young adults and elderly persons had nearly identical
9.0-fold increases (95% confidence interval 6.7 to 12.1-fold) in
their geometric mean antibody levels (p less than 0.0001 by paired
sample t-test for both groups). Importantly, human antibodies
induced in the clinical studies were able to protect against lethal
disease caused by pneumococci when transferred to animals, and also
could be shown to bind to the surface of pneumococci. The induction
of cell-surface-binding antibodies is a key finding, since such
antibodies can attach to the outer surface of pneumococci, where
they could interact with other components of the immune system to
destroy the bacteria before they induce disease. Based on these
promising results, ID Biomedical has now received clearance from
the Canadian regulatory authorities to initiate a Phase 1 study in
infants, the major target population for this vaccine. The initial
Canadian study of PGCvax in infants will enroll 75 infants. It will
use a randomized, comparator-controlled, double-blind,
dose-escalation design to evaluate the safety, local and systemic
tolerance, and immunogenicity of PGCvax. Each child will receive
four vaccine injections: at 2, 4 and 6 months of age and a booster
dose at one year. ID Biomedical plans to begin enrollment this
month. A similar protocol will be carried out in Israel in order to
provide data in a population where pneumococcal carriage is
acquired early in infancy; this trial is expected to begin later in
the spring. While pneumococcal vaccines exist, there is currently
no vaccine available that can protect universally against all 90
serotypes. Available pneumococcal vaccines are strain- (serotype)
specific and cover only a minority of the 90 pneumococcal
serotypes. One polysaccharide vaccine available for high-risk
adults and the elderly covers 23 different serotypes.
Unfortunately, this vaccine is not reliably protective against
pneumococcal pneumonia and also does not induce any significant
antibody response in very young children, where the burden of
disease is the highest. A polysaccharide conjugate vaccine was
developed specifically for children under 5 years of age, and has
been highly effective at preventing diseases caused by the seven
serotypes that have been the most common disease-causing serotypes
to date in young children. This vaccine has been widely used in the
United States since its introduction in 2000. Recently, however, it
has been observed that other serotypes not included in that vaccine
have infected children immunized with this vaccine at a higher rate
than non-vaccinated children, a phenomenon known as 'serotype
replacement'. "The emerging evidence for serotype replacement
highlights the need for a new vaccine that is protective against
all serotypes of pneumococci. Our candidate vaccine elicits
antibodies that bind to the surface of pneumococci and that
recognize strains from all 90 known serotypes. This lends support
to the concept that PGCvax could protect against diseases caused by
all known strains of pneumococcus. Also important is that
Streptococcus pneumoniae is a major cause of serious illness and
mortality worldwide, thereby leaving a clear unmet medical need
that PGCvax has the potential to address," said Ronald W. Ellis,
Ph.D., Senior Vice President, Development for ID Biomedical. "Like
many important pathogens, pneumococci cause a significant morbidity
and mortality at the extremes of the age spectrum. PGCvax offers
potential advantages in both the very young and elderly
populations, and our clinical development strategy will address
needs in both groups," Dr. Ellis added. Unlike existing
pneumococcal vaccines, which are based on bacterial
polysaccharides, PGCvax is a subunit vaccine based on two novel
proteins found on the cell surface of pneumococci. These two
proteins are found in strains from all 90 known pneumococcal
serotypes, and the immune response to these proteins has been shown
to be protective in preclinical models. ID Biomedical's development
of innovative, protein-based vaccines, including PGCvax, is
supported, in part, through a Technology Partnerships Canada (TPC)
conditionally repayable investment of up to $80 million. "We are
very proud to have Industry Canada's participation in this program.
We are working jointly with the Canadian Government in many
sectors, and we are very appreciative of their support. Such
collaborations allow us to go one step further in becoming a
leading vaccine company," said Anthony Holler, MD, Chief Executive
Officer of ID Biomedical. About Streptococcus pneumoniae S.
pneumoniae is a leading cause of bacterial meningitis, sepsis,
pneumonia, and otitis media in infants and young children, and of
pneumonia and invasive diseases in the elderly and
immunocompromised individuals. S. pneumoniae is a major cause of
morbidity and mortality worldwide. The burden of disease and
mortality in children is significant. Invasive pneumococcal disease
accounts for approximately 200 deaths annually in the United States
in children less than 5 years of age. In this same group, over 700
cases of meningitis, 13,000 blood infections and over 5 million
cases of otitis media were reported annually. Worldwide,
approximately 1,800,000 deaths per year are caused by acute
respiratory infections in children under 5 years old, and most of
these are due to S. pneumoniae. The current market for pneumococcal
vaccines exceeds US$1 billion per year, and is expected to continue
to show strong growth during the coming decade. 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 more information,
please contact: Investor Relations/Media Dean Linden Michele Roy,
(604) 431-9314 (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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