BELLEVILLE, ON, Aug. 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, # 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 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.
SOURCE Bioniche Life Sciences Inc.