World’s First Cattle Vaccine to Reduce E. coli O157 Threat
Receives Full Licensing Approval in Canada
EconicheTM now available to reduce risk of food and water contamination
ON, October 27, 2008 – Bioniche Life Sciences Inc. (TSX: BNC), a research-based,
technology-driven Canadian biopharmaceutical company, today announced that
Econiche™, the world’s first
vaccine designed to reduce the shedding by cattle of
coli) O157:H7, has received full licensing approval from the
Canadian Food Inspection Agency (CFIA).
is now available for unrestricted use by Canadian cattle producers and their
Econiche is a Canadian discovery
developed by Bioniche Life Sciences Inc. The vaccine has the potential to
significantly reduce the amount of
O157 shed into the environment by beef and dairy cattle and, in turn, reduce the
risk to human health. The
arrives on the heels of
an outbreak in
where more than 200 people are reporting symptoms and there are almost 40
lab-confirmed cases of human illness including one case of Haemolytic Uremic
Syndrome (HUS). The illnesses are associated with a
Harvey’s Restaurant in that community.
Another outbreak involves iceberg lettuce, with 50 people made ill in
Ontario since early
Most strains of
E. coli are harmless but some, like
O157:H7, can cause severe illness and even be fatal when ingested by humans
from contaminated meat, vegetables or water. Vaccination of cattle with
Econiche can help reduce the risk of food
and waterborne contamination with
E. coli O157:H7 but they don’t get
sick. Where the disease comes from is people encountering contaminated food or
water, usually from cow feces,” said Dr. Brett Finlay,
Columbia microbiologist and bacterial diseases
expert, whose research led to the development of the vaccine. “If we
block the colonization of cows by O157, we basically decrease the number that
humans are exposed to, and thus, dropping the disease levels in humans.”
interventions to reduce the shedding of
coli O157:H7 by cattle, such as simple vaccination of cattle with
Econiche, have the potential to reduce
food and water contamination and the consequences associated with human
infection with the deadly bacteria. Clinical trials conducted with
Econiche have shown a significant
reduction in the amount of
E. coli shed
in the manure of vaccinated cows.
been trying to do our part to be an industry leader in food safety,” said
Kym Anthony, owner of specialty beef producer Top Meadow Farms in
who has been using the vaccine for the past year under
Permit to Distribute Veterinary Biologics.
E. coli vaccine fits
into that. It’s been a missing link in the industry thus far.”
Human exposure and infection with
E. coli O157:H7 can result
in serious health consequences, including abdominal pain and severe bloody
diarrhea. In severe cases, kidney damage can occur and progress to serious
complications and even death.
announcement of this vaccine’s full Canadian licence is great
news,” said Dr. Hazel Lynn, Medical Officer of Health for the Grey Bruce
Health Unit, which includes the town of Walkerton, Ontario, where seven people
died and more than 2,000 became ill in May 2000 as a result of contamination of
the town’s water supply with
O157:H7 in cattle manure from a local farm. “This is an innovative way to
reduce this public health risk.”
Another important risk area for
the public to be infected by the bacteria is through contact with farm animals
at petting zoos and agricultural exhibitions. Vaccinating these animals with
Econiche can help greatly reduce this risk
of bacteria transmission, something that has been recognized by the Canadian
Association of Fairs and Exhibitions (C.A.F.E.).
“C.A.F.E. supports any
intervention that will reduce the amount of
coli O157:H7 that is shed by cattle and may enter the environment,
water and/or food chain,” said Rudy Friesen, President of C.A.F.E.
“C.A.F.E. also recommends widespread adoption of a proof of vaccination
policy throughout Canada, which will ensure that the fairs and exhibition
sector has taken all reasonable steps for the public to safely interact with
Econiche will be manufactured in the
Bioniche production facility in
Ontario, where a $25-million expansion is
taking place, supported by the
and Canadian governments. Vaccine supply will be limited during this
manufacturing expansion period.
E. coli O157:H7
An estimated 100,000 cases of
human infection with the
E. coli O157:H7
organism are reported each year in
Two to seven 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%). Five percent of HUS patients die, many of them
children and senior citizens, whose kidneys are more sensitive to damage.
In addition to being infected
by contaminated food or water, individuals can become infected from
E. coli O157:H7 by visiting animal
exhibits. Petting zoos, fairs, and agricultural exhibits provide many possible
routes of transmission for
Direct animal contact is the obvious route, but contact with contaminated products
(e.g., sawdust, shavings, soiled clothing or shoes) can also lead to human
Econiche received international recognition in
September 2007 by the Animal Pharm Industry Excellence Awards as the best new
veterinary product for livestock globally. The vaccine has been developed by a
strategic alliance formed in 2000 between the University of British Columbia
(UBC), the Alberta Research Council (ARC), the
Vaccine & Infectious Disease Organization (VIDO), and
Bioniche, which holds the rights for worldwide
commercialization of the vaccine. The vaccine prevents the
E. coli O157 bacteria from attaching to
the intestines of vaccinated cattle, thereby reducing their reproduction within
the animal, and reducing the amount of bacteria that can be released through
cattle manure in the environment. More than 30,000 cattle have been involved in
clinical testing of the vaccine over the past six years.
Two articles were published in a peer-reviewed
Journal of Food Protection, with regard to the efficacy of
Econiche. These articles were related to
field challenge studies conducted at the
involving close to 900 animals in 2002 and 2003. Among the findings by
researchers Dr. David Smith and Dr. Rod Moxley et al: Vaccinating a majority of
cattle within a pen resulted in a significant protective effect to unvaccinated
cattle in the same pen. This effect is called “herd immunity”.
Another article was recently published in
Foodborne Pathogens and Disease
outlining the outcome of a clinical vaccine trial of commercially fed cattle that
tested the effect of a two-dose regimen of
against type III secreted proteins of enterohemorrhagic
Escherichia coli (
E. coli) O157:H7 on the probability of
detecting the organism on environmental sampling devices.
Bioniche Life Sciences Inc. is
concurrently working to meet the requirements for a
U.S. conditional license for
Econiche. The United States Department of
Agriculture (USDA) informed the Company in February of this year that the
latest data for
“meets the ‘expectation of efficacy’ standard” and is
eligible for a conditional license, providing that the Company develops a plan
“that would collect sufficient data to move the product to full
licensure”. The conditional license, when granted, will provide the
Company full access to the
market with two restrictions: At least one step in the manufacturing process
must be performed in the
will not be permitted to use the trademark for the vaccine.
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 for human and
animal health markets worldwide. The fully-integrated company employs
approximately 200 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.
has been named one of
Top Ten Life Sciences Companies for 2008. For more information, please visit www.Bioniche.com.
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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