BELLEVILLE, Canada, August 7,
2012 /PRNewswire/ --
Bioniche Life Sciences Inc. (TSX: BNC) (ASX: BNC), a
research-based, technology-driven Canadian biopharmaceutical
company, today announced that the Veterinary Medicines Directorate
(VMD) of the Department for the Environment, Food and Rural Affairs
in United Kingdom has approved the
importation of the Company's cattle vaccine against E. coli
O157 for use under the conditions of a Special Treatment
Certificate (STC).
Dr. Chris Low, Director of One
Health at the Royal (Dick) School of Veterinary Studies,
University of Edinburgh, has been
working with public health agencies in the UK, and with veterinary
surgeons and various parts of the agricultural industry, to reduce
the risk of E. coli O157 exposure. "Farming and livestock
agriculture are vital to feeding a growing global population," said
Dr. Low, "but One Health focusses on the disease risks and
challenges brought about by the interactions between animals,
humans and the environment, and I am very pleased that here we have
available in the UK a new approach to control of this
infection."
STCs are issued to veterinary surgeons when an appropriate
remedy for an animal disease is not available in the UK, but can be
accessed from another country. In this precedent-setting case, the
VMD recognised that, although E. coli O157 does not cause
illness in ruminants, the bacterium occurs naturally in domestic
cattle and they are the primary reservoir of this human pathogen.
"I am very pleased to see an STC issued for this application,"
added Dr. Low. "On-farm vaccination is a logical preventative
measure to reduce the risk of human exposure to E. coli O157
and this initiative by Bioniche Life Sciences adds to the armoury
of those involved in livestock agriculture to ensure that, in the
many contexts where country meets city, human illness is not a
result. The first application of this vaccine is likely to be in
those scenarios where the public is at direct risk of exposure on
farms."
In the longer term, the Company will be pursuing formal
regulatory approvals in Europe.
This will require that the vaccine meets Good Manufacturing
Practices (GMP) production standards. The Company's Animal Health
and Food Safety Vaccine Manufacturing Centre in Belleville, Ontario is currently undergoing
validation to meet North American production standards. Reaching
GMP compliance will require an additional 12-18 months of
validation work.
New Peer Reviewed Journal Article
The immunological response of dairy cattle to vaccination with
the Company's E. coli O157 vaccine has been summarised in a
recently published peer reviewed journal article in The Bovine
Practitioner - Vol. 46, No. 1. The article, entitled,
"Immunological response of dairy cattle housed at an Ontario animal exhibit to vaccination with
Escherichia coli O157 Type III secreted proteins", was
co-authored by Glenn G. Smith,
Susan E. Goebel, Louis A. Guilbault, and Louisa Zak.
The article summarised a retrospective study to: 1. Assess the
serological response of mature and naïve animals to vaccination
with Type III secreted proteins (TTSP) antigens in a sub-unit
vaccine under field conditions; 2. Compare the difference in immune
response to a two-dose vs. three-dose vaccination protocol; and 3.
Measure antibody response following annual booster.
The study demonstrated that all animals, including young calves,
immunologically responded to vaccination against E. coli
O157 TTSP. A two-dose vaccination schedule provided a similar level
of antibody titre as a three-dose protocol. All animals
immunologically responded to a single annual booster
vaccination.
The study was conducted at the Canada Agriculture Museum in
Ottawa, Ontario, Canada, over a
four-year time period from 2007 to 2010, with immunological
assessment occurring during 2009 and 2010. Cows received either two
or three doses of vaccine in the study period and there were no
adverse events reported.
About E.
coli O157
E. coli O157 can cause severe illness and may be fatal
when ingested by humans from contaminated meat, vegetables, other
food products, or water. Human exposure and infection with E.
coli O157 can result in serious health consequences, including
abdominal pain and severe bloody diarrhoea. In severe cases, kidney
damage can occur and progress to serious complications and even
death. Lingering, long-term medical conditions may persist in
individuals exposed to the bacterium. These include post-infectious
irritable bowel syndrome (PI-IBS), reduced kidney function,
diabetes, hypertension and reactive arthritis.
E. coli O157 is commonly carried by animals and ruminants
but will cause the animals to show no signs of infection even
though there is potential for spread of E. coli O157 in
their faeces. Therefore, agricultural and environmental exposures,
particularly contact with ruminants, are well-recognised as being
linked to E. coli O157 human infections, both outbreaks and
individual illnesses. In the UK, there have until now been no
established on-farm options for E. coli O157 control.
Although E. coli O157 infection is relatively uncommon, it
is a serious public health issue in the UK, parts of Europe and North
America. The UK experienced a devastating E. coli
O157 outbreak at Godstone Farm in Surrey, a visitor farm, in 2009. A total of 93
people became ill, 76 of whom were children under the age of 10.
Twenty-seven of the affected individuals were hospitalised and 17
developed serious kidney problems.
The Health Protection Agency's report of the independent
investigation into the Godstone Farm outbreak was published in
June, 2010. The investigation was led by Professor George Griffin, Professor of Infectious Diseases
and Medicine at St. George's,
University of London. The report
highlighted the particular risks to young children, the potential
for exposure to infection from animals, and recommendation 41 was,
"The study of the feasibility of vaccine control of E. coli
O157 in ruminant animals in the UK, and identification of obstacles
to its implementation."
An estimated 100,000 cases of human infection with the E.
coli O157 organism are reported each year in North America. Two to seven per cent of those
people develop haemolytic uraemic syndrome (HUS), a disease
characterised by kidney failure. Five percent of HUS patients die,
many of them children and senior citizens, whose kidneys are more
sensitive to damage. Among the many outbreaks recorded, a 1996
Japanese outbreak made more than 9,000 people sick while the
Walkerton, Ontario outbreak in
2000 caused illness in 2,500. Recent outbreaks or recalls have been
tied to ground beef in Brussels,
raw milk in New York, Greek salad
in Western Australia, and romaine
lettuce and ground beef in Canada.
A six-year-old Massachusetts boy
died in May of this year after becoming infected with E.
coli O157:H7.
About Bioniche Life Sciences Inc.
Bioniche Life Sciences Inc. is a research-based,
technology-driven Canadian biopharmaceutical company focussed on
the discovery, development, manufacturing, and marketing of
proprietary and innovative products for human and animal health
markets worldwide. The fully-integrated company employs more than
200 skilled personnel and has three operating divisions: Human
Health, Animal Health, and Food Safety. The Company's primary goal
is to develop and commercialise products that advance human or
animal health and increase shareholder value.
Bioniche Life Sciences Inc. has been named one of the Top 50
Best Small and Medium-Sized Employers in Canada for 2011. For more information, please
visit http://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:
Jennifer Shea, Vice-President,
Communications, Investor & Government Relations
Bioniche Life Sciences Inc.
Telephone: (613)-966-8058; from Australia: 0011-1-613-966-8058; from the UK:
001-613-966-8058
Cell: (613)-391-2097; from Australia: 0011-1-613-391-2097; from the UK:
001-613-391-2097
Jennifer.Shea@Bioniche.com
(BNC.)
