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ID Biomedical announced that Dr. Scott Halperin of the Clinical Trials
Research Center at IWK Health Centre and Dalhousie University in Halifax,
Nova Scotia, presented Phase I Clinical Trial results for the FluINsure(TM)
flu vaccine at the 42nd Interscience Conference on Antimicrobial Agents and
Chemotherapy (ICAAC) in San Diego, CA. The FluINsure flu vaccine is the
Company's intranasally administered, non-living vaccine for the prevention
of influenza.
The clinical trial demonstrated that FluINsure(TM), which is a trivalent
product, was strongly immunogenic. Statistically-significant increases in
both serum hemagglutination inhibiting (HAI) antibody and in virus-specific
secretory IgA antibodies in the nose were shown for all three types of
influenza viruses (A/H1N1, A/H3N2, and B) represented in the vaccine. Serum
HAI antibody is an accepted correlate of immunity to influenza, and nasal
secretory IgA antibody responses have received attention as an additional
marker of disease resistance induced by live, attenuated nasal influenza
vaccines. In addition, FluINsure was well-tolerated by healthy adults in
this randomized, double-blinded, and placebo-controlled trial. Only mild and
short-lived runny nose was associated with the active vaccine when compared
to placebo. 'Based on the results of this trial, the FluINsure flu vaccine
appears to be quite competitive, in terms of both safety and immunogenicity,
with other nasal flu vaccines,'said Dr. Halperin.
'These are very encouraging results,'said Dr. Louis Fries, Vice President
for Clinical and Regulatory Affairs. 'Across all subjects who got active
vaccine, the average increase in serum HAI antibody levels to all three
viruses was 3.2-fold. However, if you consider those subjects who entered
the study with levels of serum HAI antibody below the presumed protective
level - those who needed protection - the average increase was 5.3-fold.
Virus-specific nasal IgA responses, which are technically harder to measure,
were also strong in both all subjects and in subjects without clear
pre-existing immunity, averaging 2.3 to 2.6-fold. While the two-dose group
did have larger antibody rises, we were pleased to see significant immune
responses in every treatment group. Overall, we saw significant, potentially
protective, serum and/or nasal antibody responses in 71, 87, and 90% of
subjects who entered the study without evidence of existing immunity to the
A/H1N1, A/H3N2, or B viruses, respectively.'
The FluINsure flu vaccine is currently undergoing Phase II testing to
further define an optimal dosing regimen. Results from the Phase II study
are expected in Q4 2002. Subsequently, the Company plans to evaluate the
vaccine in one or more challenge trials.
FluINsure is based on the Company's proprietary Proteosome(TM) vaccine
delivery/adjuvant technology. The flu vaccine is created by combining
Proteosome proteins with a purified preparation of influenza proteins that
includes the hemagglutinin protein. Importantly, unlike some other nasal
influenza vaccines in development, FluINsure contains no live viruses.
Intranasal vaccines based on the Proteosome delivery system, and
incorporating a variety of different antigens, have now been tested in over
360 people and have had a very encouraging safety profile.
About ID Biomedical
ID Biomedical is a North American based biotechnology company focused on
the development of proprietary subunit vaccine products, including those
based on its Proteosome(TM) platform intranasal adjuvant/delivery
technology. ID Biomedical has also developed a proprietary genomics analysis
system, Cycling Probe(TM) Technology.
ID Biomedical is developing subunit vaccines for the prevention of a
number of different diseases. The Company's lead products in clinical
development are the FluINsure(TM) intranasal influenza (flu) vaccine and the
StreptAvax(TM) group A streptococcal vaccine. Additionally, the Company has
a number of vaccines in preclinical development.
ID Biomedical is licensing Cycling Probe Technology as well as its broad
patents in signal amplification to the genomics and diagnostic industry for
further products and technology development. Several companies have obtained
rights to ID Biomedical's patent portfolio.
The foregoing information contains so-called forward-looking statements.
These include statements about ID Biomedical's expectations, beliefs,
intentions or strategies for the future, which it indicates 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 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 ability to successfully complete preclinical and
clinical development of its products; ii) the ability to obtain and enforce
timely patent and intellectual property protection for its technology and
products; iii) the ability to avoid, either by product design, licensing
arrangement or otherwise, infringement of third parties'intellectual
property; iv) decisions, and the timing of decisions, made by
the health regulatory agencies regarding approval of its products for
human testing; v) the ability to complete and maintain corporate alliances
relating to the development and commercialization of its technology and
products; vi) market acceptance of its technology and product; and (vii) the
competitive environment and impact of technological change. ID Biomedical
bases its forward-looking statements on information currently available to
it, and assumes no obligation to update them.
CONTACT: TEL: (604) 431-9314 ID Biomedical Corporation
Dean Linden, Manager, Corporate Communications
INET : www.idbiomedical.com
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