Special Treatment Certificate Issued for Importation of E. coli O157 Vaccine into the United Kingdom

Aug 07, 2012, 16:00 ET from Bioniche Life Sciences Inc.

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.