7,50 erreicht. Am 13.03.03 wird steuerfrei verkauft.
Phase 2 von FluINsure läuft zwar vielversprechend, aber böse Überraschungen kanns leider
immer geben. Bis jetzt glauben aber alle an einen Blockbuster und decken sich ein.
Gruss E.
ID Biomedical announces positive results from Phase II testing of FluINsure(TM) vaccine TRADING SYMBOLS - NASDAQ - "IDBE", TSX - "IDB"
VANCOUVER, Dec 03, 2002 /PRNewsire-FirstCall via Comtex/ -- ID Biomedical today
announced positive results on its two Phase II Clinical Trials of FluINsure(TM),
the Company's intranasally delivered influenza vaccine. Results of these
ongoing, randomized, double blind and concurrent placebo-controlled studies,
which enrolled a total of 99 healthy adult subjects, confirm the positive
results of the previously reported Phase I study.
The FluINsure vaccine continued to exhibit a favorable safety and tolerability
profile, with no serious adverse events and only mild and transient nasal
stuffiness and/or runny nose being associated with the active vaccine when
compared to a placebo nasal spray.
Statistically-significant increases in serum hemagglutination-inhibiting (HAI)
antibodies were induced by all regimens tested, including both one- and two-dose
regimens, at 28 days post immunization. For both influenza A strains included in
the vaccine, serum HAI antibody titers increased by an average of 2.4-fold in
the one-dose group and 2.5-fold in the two-dose groups. Among those subjects who
had low pre-existing serum HAI titers prior to immunization with the FluINsure
vaccine (suggesting that they were therefore more susceptible to influenza), HAI
titers increased an average of 3-fold in one- dose recipients and 4.2-fold in
the two-dose groups. Rises in HAI antibodies to influenza B component were lower
in all groups likely because of high levels of pre-existing immunity to the
influenza B strain in the study population.
Statistically-significant rises in nasal secretory antibody levels of 1.7 to
3.2-fold were noted in the two-dose groups. Nasal antibody measurements in the
one-dose group are not yet complete. Data from the one-dose group, as well as
final data analysis on this Phase II study will be completed in mid January.
"We're very pleased with this data," said Dr. Louis Fries, Vice President of
Clinical and Regulatory Affairs. "These studies build on the positive data from
previous trials and give us important information on the FluINsure vaccine's
performance in terms of the consistency from lot to lot. That's a very important
point, because we must be able to deal with new strains of the influenza virus
each year without changing our production process." Dr Fries also noted,
"Overall the serum and nasal antibody results from our studies are clearly
competitive with or superior to, those reported in published studies of other
nasal flu vaccines that have proven protective in challenge studies and in the
field."
Dr Fries will be presenting initial data from these studies and summary data
from previous studies of the FluINsure vaccine, at the 5th International
Symposium on Respiratory Viral Infections, on December 7, 2002.
Additionally, the Company reported today that all study subjects in the Phase II
Challenge Trial in Great Britain, have received either the FluINsure vaccine or
a placebo intranasally (see news release titled 'ID Biomedical announces start
of FluINsure(TM) vaccine challenge trial' dated November 26, 2002). Study
subjects will be challenged with live influenza in early January and the Company
expects to report results in February. These Phase II clinical studies are being
conducted to gather data on the FluINsure vaccine in preparation for the first
large field trial of protective efficacy, which the Company expects to initiate
in time for the 2003-4 influenza season.
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
product 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 product,; vi) market acceptance of
its technology and products;, and (vii) the competitive environment and impact
of technological change. There is no guarantee that the development path from
Phase I to Phase II to Phase III and so on will be either linear or successful.
ID Biomedical bases its forward-looking statements on information currently
available to it, and assumes no obligation to update them.
Contacts: ID Biomedical Corporation
Dean Linden
Manager, Corporate Communications
(604) 431-9314
www.idbiomedical.com
SOURCE ID Biomedical Corporation
