- significant reduction in environmental contamination
following two-dose vaccination of cattle -
BELLEVILLE, ON, Oct. 17 /CNW/ - Bioniche Life Sciences Inc. (TSX: BNC), a
research-based, technology-driven Canadian biopharmaceutical company, today
announced that the results of a large-scale commercial beef feedlot study with
the Company's E. coli O157 vaccine have been published in Foodborne Pathogens
and Disease (Vol. 5, Number 5, 2008), a peer-reviewed scientific journal.
The article is entitled, "A Two-Dose Regimen of a Vaccine Against
Escherichia coli O157:H7 Type III Secreted Proteins Reduced Environmental
Transmission of the Agent in a Large-Scale Commercial Beef Feedlot Clinical
Trial" (David R. Smith, Rodney A. Moxley, Robert E. Peterson, Terry J.
Klopfestein, Galen E. Erickson, and Sharon L. Clowser).
The clinical vaccine trial of commercially-fed cattle tested the effect
of a two-dose regimen of a vaccine product against type III secreted proteins
of enterohemorrhagic Escherichia coli (E. coli) O157:H7 on the probability of
detecting the organism on environmental sampling devices.
Vaccine was administered to all cattle within treated pens at arrival
processing and again at routine re-processing. Pens of cattle were sampled for
four test periods - one week after the second dose of vaccine and every three
weeks thereafter. Test samples were taken from seven ropes per pen hung
overnight from the feed-bunk neck-rail (the ROPES method). The study involved
20,556 cattle, held in 140 pens at 19 feedlots, over the period between
February and October of 2004. Vaccinated pens of cattle were less likely to
test ROPES-positive (OR=0.59, p=0.004). Because ROPES testing identifies
organisms in the mouth of cattle, and its outcome is proven to be both
associated with presence of the organism in the pen environment and correlated
with the prevalence of fecal shedding, the researchers concluded that the
two-dose vaccine regimen reduces the probability for environmental
transmission of E. coli O157:H7 within commercial cattle feeding systems.
"This is further peer-reviewed evidence of the efficacy of the Bioniche
E. coli O157 vaccine," said Dr. Dragan Rogan, Vice-President, Animal Health
Research & Development at Bioniche Life Sciences Inc. "Although this
successful study was conducted using a two-dose regimen, it is important to
note that the initial regulatory approval for the vaccine will be based upon a
three-dose regimen. The ultimate goal of the vaccine is the maximum possible
reduction of the prevalence of the E. coli bacterium in cattle environments,
from which it contaminates water, produce or meat and harms people."
Recent E. coli O157:H7 outbreaks include one in North Bay, Ontario,
Canada, where there are 15 lab-confirmed cases of human illness and another 78
under investigation as of this week. The illnesses are connected to a Harvey's
Restaurant outlet in that community. Another recent outbreak involves iceberg
lettuce, with 50 people made ill in Michigan, Illinois and Canada starting in
early September, 2008.
About Foodborne Pathogens and Disease
This peer-reviewed, international journal publishes original papers and
short communications on research and diseases caused by foodborne pathogens.
Topics include emerging pathogens; emergence of drug resistance; methods and
technology for rapid and accurate detection; strategies to destroy or control
foodborne pathogens in food production and processing; and development of
novel strategies for the prevention and control of plant and animal diseases
that impact food safety. The Journal includes timely reviews and special
reports on topics such as agro-terrorism and the safety of organically grown
and genetically modified foods.
About E. coli O157:H7
An estimated 100,000 cases of human infection with the E. coli O157:H7
organism are reported each year in North America. Two to seven per cent of
those people develop hemolytic 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 E. coli. Direct animal contact (e.g., feces, fur, saliva) is
the obvious route, but contact with contaminated products (e.g., hand-rails,
sawdust, shavings, soiled clothing or shoes) can also lead to human infection.
About the E. coli O157 Vaccine
The Bioniche E. coli O157 vaccine 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 University of Saskatchewan's
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, the Journal of
Food Protection, last November in regards to the efficacy of the E. coli
vaccine. These articles related to field challenge studies conducted at the
University of Nebraska-Lincoln 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".
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 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. Bioniche has been named one of Canada's Top Ten Life Sciences
Companies for 2008. 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.
For further information:
For further information: Jennifer Shea, Vice-President, Communications,
Investor & Government Relations, Bioniche Life Sciences Inc., Telephone: (613)
966-8058, Cell: (613) 391-2097, Jennifer.Shea@Bioniche.com