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Attention Business Editors
Canadian Research Collaboration Produces World's First Food Safety Vaccine: Against E. coli 0157:H7
BELLEVILLE, ON, Jan. 10 /CNW/ - Bioniche Life Sciences Inc. (TSX: BNC), a
research-based, technology-driven Canadian biopharmaceutical company, today
reiterated the significance of being part of a collaboration leading to the
world's first food safety vaccine: a cattle vaccine against E. coli 0157:H7.
The collaboration included the University of British Columbia and the Vaccine
and Infectious Disease Organization. Bioniche Life Sciences is announcing
today that it is scaling up production of the vaccine in order to ensure
sufficient supply to meet Canadian demand.
The Company previously announced (on December 22, 2006), that it, as the
commercialization partner, has received authorization from the Canadian Food
Inspection Agency (CFIA) to distribute the E. coli 0157:H7 cattle vaccine to
Canadian veterinarians. CFIA is allowing distribution of the vaccine under a
Permit to Release Veterinary Biologics as specified in the Canadian Health of
Animal Regulations. This equates to a conditional license in the U.S.
Recent outbreaks of E. coli 0157:H7 affecting spinach and other produce
in North America have highlighted the fact that this is an increasingly
serious human threat that goes beyond meat (the first major foodborne outbreak
of E. coli 0157:H7 occurred in 1982 and was associated with ground beef).
Human exposure to E. coli 0157:H7 is being increasingly associated with
contaminated fruit, vegetable, unpasteurized milk and fruit juice, potable and
recreational water, and from direct contact with animals at fairs and petting
zoos.
"This vaccine will ensure that Canadian cattle producers continue to
provide a safe product for Canadian consumers," said Dr. Lorne Babiuk,
Director of the Vaccine and Infectious Disease Organization (VIDO) and Canada
Research Chair in Vaccinology and Biotechnology in Saskatoon, Saskatchewan.
"More importantly, the reduction of E. coli shedding into the environment will
have far-reaching consequences regarding environmental contamination. The
recent outbreaks of E. coli infection from consumption of vegetables is an
example of additional benefits of such a vaccine. The key discovery to making
this vaccine a reality was made by Dr. Brett Finlay at the University of
British Columbia, when he deciphered the mechanisms by which E. coli attaches
to and infects animals. Using this knowledge, it was possible to target the
specific proteins of the bacterium for use in the vaccine."
"It is wonderful to see that this vaccine can be used to prevent the
tragic food and waterborne outbreaks associated with this organism," added Dr.
Brett Finlay, Professor, Michael Smith Laboratories, University of British
Columbia. "It is also a great feeling to see all the work that went into the
basic discoveries being applied to a vaccine that should have real impact on
Canadians' health."
The Bioniche E. coli 0157:H7 cattle vaccine was one of the interventions
referenced in an article in the journal, Nature (vol. 445, 4 January, 2007).
The article, entitled "The dark side of E. coli", discusses recent human
health outbreaks caused by E. coli 0157:H7 bacteria in food products. The
article referenced the Bioniche vaccine as a "promising research lead that
might help prevent future outbreaks."
"Our vaccine is the first product to be registered globally as a
pre-harvest (pre-slaughter) intervention," said Graeme McRae, President & CEO
of Bioniche Life Sciences Inc. "It will be an important supplement to
post-harvest (post-slaughter) interventions already implemented by the
meatpacking industry."
About the Bioniche E. coli 0157:H7 Cattle Vaccine
Clinical trials have been conducted with the Bioniche E. coli 0157:H7
cattle vaccine over the past four years involving more than 30,000 cattle.
Studies have consistently shown a significant decrease in the number of cattle
shedding these deadly bacteria in their manure. In a controlled experiment
conducted at VIDO, vaccinated cattle were challenged with a very large dose of
bacteria, and there was a reduction in the magnitude of shedding by 99.47 per
cent. In clinical trials conducted by the University of Nebraska-Lincoln in
commercial feedlot settings (where vaccinates and non-vaccinates were mixed),
there was a 75 per cent lower prevalence of E. coli 0157:H7 in cattle
vaccinated with two doses of the Bioniche vaccine. Another three-dose
vaccination study was performed by the university, which showed that
vaccinated cattle were 98.3 per cent less likely to colonize the bacteria in
their intestine.
About E. coli 0157:H7
Escherichia coli (E. coli) bacteria are normal organisms found in the
intestinal tract of all animals and humans. Most E. coli are non-pathogenic
(non-disease-causing) to their host; however, certain strains can cause
intestinal disease and, occasionally, other significant systemic disease. The
E. coli 0157:H7 bacterium, which was first identified in South America in the
late 1970s and drifted northward, produces a powerful toxin (shiga/vero toxin)
that can cause severe illness in humans and often result from consumption of
contaminated food or water. Today, the bacteria can be found in most cattle
herds in North America, South America, Europe and Asia. Ruminant livestock
(e.g. cattle) are considered the major reservoir of E. coli 0157:H7 worldwide.
Numerous studies have demonstrated that the incidence of E. coli 0157:H7 in
beef and dairy cattle is widespread and that the organism is found in, on and
around cattle in all parts of the world. Use of manure as fertilizer from crop
production and run-off from beef and dairy cattle operations are a source of
contamination for the general environment, as well as surface and ground
water. E. coli 0157:H7 contamination of food and water as a result of fecal
shedding by livestock is a well-recognized and documented threat to human
health.
About E. coli 0157:H7 Infection
The U.S. Centers for Disease Control estimates that E. coli 0157:H7
infection affects some 73,000 people per year in the United States, and that
2 per cent to 7 per cent of those people develop haemolytic uremic syndrome
(HUS), a disease characterized by kidney failure (in recent outbreaks, this
percentage has risen to as high as 16 per cent). Five per cent of HUS patients
die, many of them children and senior citizens, whose kidneys are more
sensitive to damage. Health Canada identified 1,038 reported cases of E. coli
0157:H7 infection in Canada in 2004. The annual cost in the United States is
estimated at more than $650 million due to medical expenses, lost productivity
and death.
About Bioniche Life Sciences Inc.
Bioniche Life Sciences Inc. is a research-based, technology-driven
Canadian biopharmaceutical company focused on the discovery, development,
manufacturing, and marketing of proprietary products from human and animal
health markets worldwide. The fully-integrated company employs approximately
188 skilled personnel and has three operating divisions: Human Health, Animal
Health, and Food Safety. The Company's primary goal is to develop proprietary
cancer therapies supported by revenues from marketed products in human and
animal health. For more information, please visit www.Bioniche.com .
Except for historical information, this news release may contain
forward-looking statements that reflect the Company's current expectation
regarding future events. These forward-looking statements involve risk and
uncertainties, which may cause, but are not limited to, changing market
conditions, the successful and timely completion of clinical studies, the
establishment of corporate alliances, the impact of competitive products and
pricing, new product development, uncertainties related to the regulatory
approval process, and other risks detailed from time to time in the Company's
ongoing quarterly and annual reporting.
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/For further information: Jennifer Shea, Corporate Communications &
Investor Relations Manager, Bioniche Life Sciences Inc., Telephone: (613)
966-8058, Cell: (613) 391-2097, Jennifer.Shea@Bioniche.com/
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