ID Biomedical announces final results from field efficacy trial of its intranasal flu vaccine
January 13 2005 - 11:34AM
PR Newswire (US)
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, ; 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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