October 17, 2008
E. Coli O157 Vaccine Efficacy Reinforced By Study Published in Foodborne Pathogens and Disease
BELLEVILLE, ON, Oct. 17 /PRNewswire-FirstCall/ -- 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 have been published in Foodborne Pathogens and Disease (Vol. 5, Number 5, 2008), a peer-reviewed scientific journal.
The article is entitled, "A Two-Dose Regimen of a Vaccine Against Escherichia coli O157:H7 Type III Secreted Proteins Reduced Environmental Transmission of the Agent in a Large-Scale Commercial Beef Feedlot Clinical Trial" (David R. Smith, Rodney A. Moxley, Robert E. Peterson, Terry J. Klopfestein, Galen E. Erickson, and Sharon L. Clowser).
The clinical vaccine trial of commercially-fed cattle tested the effect of a two-dose regimen of a vaccine product against type III secreted proteins of enterohemorrhagic Escherichia coli (E. coli) O157:H7 on the probability of detecting the organism on environmental sampling devices.
Vaccine was administered to all cattle within treated pens at arrival processing and again at routine re-processing. Pens of cattle were sampled for four test periods - one week after the second dose of vaccine and every three weeks thereafter. Test samples were taken from seven ropes per pen hung overnight from the feed-bunk neck-rail (the ROPES method). The study involved 20,556 cattle, held in 140 pens at 19 feedlots, over the period between February and October of 2004. Vaccinated pens of cattle were less likely to test ROPES-positive (OR=0.59, p=0.004). Because ROPES testing identifies organisms in the mouth of cattle, and its outcome is proven to be both associated with presence of the organism in the pen environment and correlated with the prevalence of fecal shedding, the researchers concluded that the two-dose vaccine regimen reduces the probability for environmental transmission of E. coli O157:H7 within commercial cattle feeding systems.
"This is further peer-reviewed evidence of the efficacy of the Bioniche E. coli O157 vaccine," said Dr. Dragan Rogan, Vice-President, Animal Health Research & Development at Bioniche Life Sciences Inc. "Although this successful study was conducted using a two-dose regimen, it is important to note that the initial regulatory approval for the vaccine will be based upon a three-dose regimen. The ultimate goal of the vaccine is the maximum possible reduction of the prevalence of the E. coli bacterium in cattle environments, from which it contaminates water, produce or meat and harms people."
Recent E. coli O157:H7 outbreaks include one in North Bay, Ontario, Canada, where there are 15 lab-confirmed cases of human illness and another 78 under investigation as of this week. The illnesses are connected to a Harvey's Restaurant outlet in that community. Another recent outbreak involves iceberg lettuce, with 50 people made ill in Michigan, Illinois and Canada starting in early September, 2008.
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 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 hemolytic 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 (e.g., feces, fur, saliva) is the obvious route, but contact with contaminated products (e.g., hand-rails, sawdust, shavings, soiled clothing or shoes) can also lead to human infection.
About the E. coli O157 Vaccine
The Bioniche E. coli O157 vaccine 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, last November in regards to the efficacy of the E. coli vaccine. These articles 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".
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 Canada's Top Ten Life Sciences Companies for 2008. 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.
Bioniche Life Sciences Inc.
CONTACT: Jennifer Shea, Vice-President, Communications, Investor &Government Relations, Bioniche Life Sciences Inc., Telephone: (613) 966-8058,Cell: (613) 391-2097, [email protected]