- study conducted with 21 pens of cattle in commercial feedlots -
BELLEVILLE, ON, March 13 /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 - Econiche(TM) - have been published in
this month's issue of Foodborne Pathogens and Disease (Vol. 6, Number 2,
2009), a peer-reviewed scientific journal.
The article, entitled, "A Two-Dose Regimen of a Vaccine Against Type III
Secreted Proteins Reduced Escherichia coli O157:H7 Colonization of the
Terminal Rectum in Beef Cattle in Commercial Feedlots", was co-authored by
David R. Smith, Rodney A. Moxley, Robert E. Peterson, Terry J. Klopfenstein,
Galen E. Erickson, Gustavo Bretschneider, Emil M. Berberov, and Sharon
Clowser.
The article summarized a large-scale clinical vaccine trial of
commercially fed cattle that tested the efficacy of a two-dose regimen of the
Econiche vaccine against type III secreted proteins of enterohemorrhagic
Escherichia coli O157:H7 on the probability to detect the same organism from
terminal rectal mucosa (TRM) as a measure of gut colonization. The TRM is the
most significant point of colonization by E. coli O157 in cattle. Vaccine was
administered to all cattle within treated pens at arrival processing and at
re-implant processing. At harvest, TRM was collected from a sample of cattle
from within vaccinated and non-vaccinated pens. Seven hundred eighteen cattle
were tested from within 21 pens of cattle (11 vaccinated and 10 not
vaccinated) representing 3,683 cattle. E. coli O157:H7 was cultured from 68 of
718 (9.5%) TRM samples. Eleven of 382 (2.9%) vaccinated cattle and 57 of 336
(17.0%) non-vaccinated cattle were TRM culture positive. From the multilevel
logistic model, vaccinated cattle were 92% less likely to be colonized with E.
coli O157:H7 than non-vaccinated cattle (odds ratio (OR)=0.07, p=0.0008). This
is the second published study demonstrating more than 90% effectiveness of the
Bioniche vaccine against colonization.
The researchers concluded that the two-dose vaccine regimen effectively
reduced the probability for E. coli O157:H7 colonization of the TRM of
commercially fed cattle at harvest. "As evidenced in this study, the number of
days elapsing between arrival processing and reprocessing can be quite
variable in typical feedlot systems," said Dr. David Smith, Extension
Dairy/Beef Veterinarian, Veterinary and Biomedical Sciences, University of
Nebraska-Lincoln. "However, we found no evidence that this affected vaccine
efficacy. Therefore, feedlot managers may have some flexibility in scheduling
re-vaccination without risking loss of efficacy. It is important that
pre-harvest intervention strategies remain effective up to the time of
harvest. Within the range of observations in this study, the protective effect
of vaccine did not change as the number of days between reprocessing and
harvest increased." This is consistent with the results from longitudinal
vaccine clinical trials of the Company's vaccine published in 2004, 2007 and
2008.
The Company's Econiche(TM) vaccine is the world's first vaccine developed
to reduce the shedding by cattle of Escherichia coli (E. coli) O157:H7.
Econiche received full licensing approval from the Canadian Food Inspection
Agency (CFIA) in October, 2008 and is available for unrestricted use by
Canadian cattle producers and their veterinarians.
The USDA cleared the path for a conditional license for the vaccine in
February, 2008, and the Company in the process of completing the required
manufacturing steps in the U.S. at this time.
Econiche is a Canadian discovery developed by Bioniche Life Sciences Inc.
The vaccine has the potential to significantly reduce the amount of E. coli
O157 shed into the environment by beef and dairy cattle and, in turn, reduce
the risk to human health. 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.
"Cows carry E. coli O157:H7 but they don't get sick. Where the disease
manifests itself is people encountering contaminated food or water, usually
from cow feces," said Dr. Brett Finlay, University of British 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."
On-farm interventions to reduce the shedding of E. 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.
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.
Econiche is manufactured in the Bioniche production facility in
Belleville, Ontario, where a $25-million expansion is taking place, supported
by the Ontario and Canadian governments. Vaccine supply will be limited during
this manufacturing expansion period.
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 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 E. coli. 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 infection.
About Econiche
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 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, with regard to the efficacy of Econiche. These articles were
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".
Another article was published in the Vol. 5, Number 5, 2008 issue of 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
Econiche against type III secreted proteins of enterohemorrhagic Escherichia
coli (E. coli) O157:H7 on the probability of detecting the organism on
environmental sampling devices.
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 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 the Top 50 Best Small and
Medium-Sized Employers in Canada for 2009. 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.
%SEDAR: 00013159EF
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
