ID Biomedical (NASDAQ:IDBE)
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ID Biomedical announces final results from field efficacy trial
of its intranasal flu vaccine
VANCOUVER, Jan. 13 /PRNewswire-FirstCall/ -- ID Biomedical Corporation (TSX:
IDB; NASDAQ: IDBE) announced today that it has completed analysis of the
vaccine immunogenicity and safety data from its 2003/04 field efficacy trial of
FluINsure(TM), a non-living intranasally delivered influenza vaccine. The trial
was carried out in 1,349 healthy subjects aged 18 to 64 in 28 Canadian sites
between October 2003 and May 2004. As previously reported, both one- and
two-dose FluINsure regimens were efficacious in preventing influenza-like
illness (two or more symptoms) in association with a positive influenza virus
culture and no FluINsure recipient experienced febrile illness associated with
culture-confirmed influenza.
The immunogenicity data from the study showed a significant rise in serum
hemagglutination-inhibiting (HAI) antibody titers, a widely accepted correlate
of protection against influenza disease, when vaccinees were compared to
placebo recipients. The increases in HAI titers were highly significant (p less
than or equal to 0.001 vs. placebo recipients) for all three vaccine viruses
(A/H1N1, A/H3N2, and B). The increases in HAI titers were statistically
indistinguishable between vaccinees who received two doses and those who
received a single dose of FluINsure(TM). In addition, significant rises (p less
than 0.001) in salivary secretory IgA specific for the vaccine viruses were
also found for all three vaccine viruses among subjects who received the active
vaccine, but not those who received placebo. Salivary secretory IgA responses
were not significantly different between subjects who received the two dose
regimen and those who received one dose.
With regard to safety, there was no statistically significant association of
local or respiratory complaints (runny nose, stuffy nose, itchy nose, nose
bleed, sneezing, sore throat, red or puffy eyes, wheezing or cough) with active
vaccine when compared with placebo (saline). Similarly, neither temperature
elevations nor systemic complaints (headache, muscle or joint aches, tiredness,
or loss of appetite) were related to receipt of FluINsure at either dosage
level. Throughout the study period, there was no statistically significant
difference in the overall incidence of adverse events reported between the
vaccine and placebo groups, and there was no significantly increased rate of
any particular class of adverse events in vaccine recipients versus placebo
recipients.
"These are very encouraging results. In a large field study, we were able to
clearly demonstrate both the systemic and mucosal immune responses to the
viruses represented in the vaccine," commented Louis F. Fries, M.D., Vice
President, Clinical and Medical Affairs. "The immunogenicity trends that we
showed in smaller studies have been validated, and we have shown immune
responses to the single-dose regimen that are in agreement with its efficacy.
The serum HAI antibody responses to the influenza A viruses induced by
FluINsure were quite robust in the context of a mucosal vaccine, and while HAI
responses to the B component were lower (a frequent finding with B virus
antigens in all influenza vaccines), they remained significant. Furthermore, we
have been able to demonstrate mucosal antibody responses using saliva, which is
a relatively easy specimen to obtain and suitable for large field studies, that
parallel our data in the more difficult nasal wash system. This will be a
useful tool in future studies. Finally, the strikingly benign safety profile of
FluINsure continues to be confirmed."
ID Biomedical also announced that it has completed enrollment of a
reimmunization study in Canada, testing FluINsure formulated with the flu
antigen acquired through the Company's purchase of Shire Pharmaceuticals'
vaccine assets. All subjects have been enrolled and have received a single dose
of FluINsure. The objective of this study is to demonstrate that the vaccine is
well tolerated and gives a strong immune response in those persons who have
received the vaccine in the previous flu season. The Company expects to have
results of this study in spring 2005. ID Biomedical plans to initiate its first
pediatric clinical studies of FluINsure in the U.S. toward the end of 2005.
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 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,
;
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