http://www.newswire.ca/releases/October2002/15/c0961.html
|
|
|
Canada NewsWire | |
|
|
||||
Attention Business Editors:
Positive Results Obtained From Preclinical Challenge Study
TRADING SYMBOLS - NASDAQ - "IDBE", TSE - "IDB"
VANCOUVER, Oct. 15 /CNW/ - ID Biomedical announced today that it has
received a favorable response from the Medicines Control Agency of the United
Kingdom with regard to its application to conduct a Phase II human "challenge"
study for the FluINsure(TM) vaccine, the Company's intranasally delivered
trivalent influenza vaccine. A Clinical Trial Exemption (CTX) has been
granted, effective as of 17 October 2002, that allows the Company to pursue
its planned Phase II safety, immunogenicity, and challenge studies in London,
England. ID Biomedical expects the study to begin in December.
"This CTX is a very significant step in our clinical trial program for
the FluINsure vaccine," said Louis Fries, M.D., ID Biomedical's Vice President
of Clinical and Regulatory Affairs. "Although we have been very pleased with
the serum and mucosal antibody responses generated in our human clinical
trials to date, and it is further true that these type of responses have been
known to correlate with protection against influenza, seeing what level of
protection can be established by the FluINsure vaccine in a human challenge
study will be very meaningful and important data."
Results of clinical trials completed thus far have shown that the
FluINsure influenza vaccine stimulates a significant immune response in both
the blood stream and on the mucosal surfaces of the respiratory tract. ID
Biomedical is now pursuing challenge studies, in which immunized subjects in a
quarantine facility are intentionally exposed to live influenza viruses to
determine if immune responses to the FluINsure vaccine translate into
protection against illness.
The Company also announced that a preclinical challenge study in the
accepted animal model confirmed both the promise and safety of the FluINsure
vaccine.
"We are very encouraged by the clinical immunogenicity data from the
FluINsure program. In addition to those data, we have also been working to
assess the protection that the FluINsure vaccine can afford against influenza
in an animal challenge model," said Dr. Fries. "Ferrets are a very important
model for the upcoming study because they develop respiratory disease very
much like human influenza when exposed to the same viruses. Over the years,
this model has been used to test a variety of influenza vaccines and antiviral
drugs. Our preliminary findings are that, when exposed to live human influenza
virus, FluINsure-immunized ferrets shed significantly less virus from their
noses than animals that have received a placebo treatment; and a significant
proportion of FluINsure-treated animals don't appear to be infected at all.
Thus, the FluINsure vaccine may be able to prevent not just illness, but also
infection and virus shedding - so it might actually interrupt transmission of
the disease."
"It is important to note," continued Fries, "that even though this model
is well-accepted, these are preclinical studies. Suffice to say that these
results, in addition to the immunogenicity data developed to date, give us
confidence in going forward to the human challenge study."
The FluINsure vaccine 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, the FluINsure
vaccine 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.
-30-
For further information: ID Biomedical Corporation, Dean Linden, Manager, Corporate Communications, (604) 431-9314, www.idbiomedical.com; To request a free copy of this organization's annual report, please go to http://www.newswire.ca and click on reports@cnw.
 |
|
 |
 |
 |
|
 |
 |
 |
|
 |
 |
 |
General Inquiries - cnw@newswire.ca Technical Issues - webmaster@newswire.ca © 2002 Canada NewsWire Ltd. All rights reserved. |
 |
ALL INFORMATION, DATA, AND
MATERIAL CONTAINED, PRESENTED, OR PROVIDED HERE IS FOR GENERAL INFORMATION
PURPOSES ONLY AND IS NOT TO BE CONSTRUED AS REFLECTING THE KNOWLEDGE OR OPINIONS
OF THE PUBLISHER, AND IS NOT TO BE CONSTRUED OR INTENDED AS PROVIDING MEDICAL OR
LEGAL ADVICE. THE DECISION WHETHER OR NOT TO VACCINATE IS AN IMPORTANT AND
COMPLEX ISSUE AND SHOULD BE MADE BY YOU, AND YOU ALONE, IN CONSULTATION WITH
YOUR HEALTH CARE PROVIDER.