BELLEVILLE, ON, Aug. 7, 2012 /CNW/ - 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.