Bioniche Life Sciences Inc., a research-based, technology-driven Canadian biopharmaceutical company, today announced that Econiche(TM), the world's first vaccine designed to reduce the shedding by cattle of Escherichia coli (E. coli) O157:H7, has received full licensing approval from the Canadian Food Inspection Agency (CFIA). Econiche is now available for unrestricted use by Canadian cattle producers and their veterinarians.
Econiche is a Canadian discovery developed by Bioniche Life Sciences Inc. The vaccine has the potential to significantly reduce the amount of E. coli O157 shed into the environment by beef and dairy cattle and, in turn, reduce the risk to human health. The Econiche full license arrives on the heels of an outbreak in North Bay, Ontario, Canada, where more than 200 people are reporting symptoms and there are almost 40 lab-confirmed cases of human illness including one case of Haemolytic Uremic Syndrome (HUS). The illnesses are associated with a Harvey's Restaurant in that community. Another outbreak involves iceberg lettuce, with 50 people made ill in Michigan, Illinois and Ontario since early September, 2008.
Most strains of E. coli are harmless but some, like O157:H7, can cause severe illness and even be fatal when ingested by humans from contaminated meat, vegetables or water. Vaccination of cattle with Econiche can help reduce the risk of food and waterborne contamination with E. coli O157:H7.
Cows carry E. coli O157:H7 but they don't get sick. Where the disease comes from is people encountering contaminated food or water, usually from cow feces, said Dr. Brett Finlay, University of British Columbia microbiologist and bacterial diseases expert, whose research led to the development of the vaccine. If we block the colonization of cows by O157, we basically decrease the number that humans are exposed to, and thus, dropping the disease levels in humans.
On-farm interventions to reduce the shedding of E. coli O157:H7 by cattle, such as simple vaccination of cattle with Econiche, have the potential to reduce food and water contamination and the consequences associated with human infection with the deadly bacteria. Clinical trials conducted with Econiche have shown a significant reduction in the amount of E. coli shed in the manure of vaccinated cows.
We've been trying to do our part to be an industry leader in food safety, said Kym Anthony, owner of specialty beef producer Top Meadow Farms in Clarksburg, Ontario, who has been using the vaccine for the past year under Permit to Distribute Veterinary Biologics. The E. coli vaccine fits into that. It's been a missing link in the industry thus far.
Human exposure and infection with E. coli O157:H7 can result in serious health consequences, including abdominal pain and severe bloody diarrhea. In severe cases, kidney damage can occur and progress to serious complications and even death.
The announcement of this vaccine's full Canadian licence is great news, said Dr. Hazel Lynn, Medical Officer of Health for the Grey Bruce Health Unit, which includes the town of Walkerton, Ontario, where seven people died and more than 2,000 became ill in May 2000 as a result of contamination of the town's water supply with E. coli O157:H7 in cattle manure from a local farm. This is an innovative way to reduce this public health risk.
Another important risk area for the public to be infected by the bacteria is through contact with farm animals at petting zoos and agricultural exhibitions. Vaccinating these animals with Econiche can help greatly reduce this risk of bacteria transmission, something that has been recognized by the Canadian Association of Fairs and Exhibitions (C.A.F.E.).
C.A.F.E. supports any intervention that will reduce the amount of E. coli O157:H7 that is shed by cattle and may enter the environment, water and/or food chain, said Rudy Friesen, President of C.A.F.E. C.A.F.E. also recommends widespread adoption of a proof of vaccination policy throughout Canada, which will ensure that the fairs and exhibition sector has taken all reasonable steps for the public to safely interact with livestock.
Econiche will be manufactured in the Bioniche production facility in Belleville, Ontario, where a $25-million expansion is taking place, supported by the Ontario and Canadian governments. Vaccine supply will be limited during this manufacturing expansion period.
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 haemolytic 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 is the obvious route, but contact with contaminated products (e.g., sawdust, shavings, soiled clothing or shoes) can also lead to human infection.
Econiche 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, with regard to the efficacy of Econiche. These articles were 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. Another article was recently published in Foodborne Pathogens and Disease outlining the outcome of a clinical vaccine trial of commercially fed cattle that tested the effect of a two-dose regimen of Econiche against type III secreted proteins of enterohemorrhagic Escherichia coli (E. coli) O157:H7 on the probability of detecting the organism on environmental sampling devices.
U.S. Regulatory Status
Bioniche Life Sciences Inc. is concurrently working to meet the requirements for a U.S. conditional license for Econiche. The United States Department of Agriculture (USDA) informed the Company in February of this year that the latest data for Econiche meets the 'expectation of efficacy' standard and is eligible for a conditional license, providing that the Company develops a plan that would collect sufficient data to move the product to full licensure. The conditional license, when granted, will provide the Company full access to the U.S. market with two restrictions: At least one step in the manufacturing process must be performed in the United States and Bioniche will not be permitted to use the trademark for the vaccine.
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 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