BELLEVILLE, ON, Dec. 22 /CNW/ - Bioniche Life Sciences Inc. (TSX: BNC), a research-based, technology-driven Canadian biopharmaceutical company, today received authorization from the Canadian Food Inspection Agency (CFIA) to distribute its E. coli O157:H7 cattle vaccine to Canadian veterinarians under a Permit to Release Veterinary Biologics as specified in the Canadian Health of Animal Regulations. This authorization equates to what is referred to as a "conditional license" in the U.S. This is the first vaccine technology for control of E. coli O157:H7 to be authorized for field use by a regulator globally. The vaccine is indicated for the reduction of shedding of E. coli O157:H7 bacteria in cattle.
"The Bioniche E. coli O157:H7 vaccine, developed through a partnership with the University of British Columbia, the Vaccine and Infectious Diseases Organization (VIDO) at the University of Saskatchewan and the Alberta Research Council, is a world's first," said Graeme McRae, President & CEO of Bioniche Life Sciences Inc. "Bioniche believes that this vaccine will be an important factor in helping to reduce the prevalence of this toxic bacterium, first implicated in meat contamination and now being increasingly identified as a contaminant of produce. CFIA's approval gives the Company a clear and manageable pathway to full licensure."
In order to progress from a Permit to Release Veterinary Biologics to a full license, the CFIA indicated that Bioniche must provide additional data confirming reduction in E. coli O157:H7 shedding by vaccinated animals. The Company believes that this requirement will be met in 2007.
"This vaccine will ensure that Canadian cattle producers continue to provide a safe product for Canadian consumers," said Dr. Lorne Babiuk, Director of the Vaccine and Infectious Disease Organization (VIDO) and Canada Research Chair in Vaccinology and Biotechnology in Saskatoon, Saskatchewan. "More importantly, the reduction of E. coli shedding into the environment will have far-reaching consequences regarding environmental contamination. The recent outbreaks of E. coli infection from consumption of vegetables is an example of additional benefits of such a vaccine. The key discovery to making this vaccine a reality was made by Dr. Brett Finlay at the University of British Columbia, when he deciphered the mechanisms by which E. coli attaches to and infects animals. Using this knowledge, it was possible to target the specific proteins of the bacterium for use in the vaccine."
Recent outbreaks of E. coli O157:H7 affecting spinach and other produce in North America have highlighted the fact that this is an increasingly serious human health threat that goes beyond meat (the first major foodborne outbreak of E. coli O157:H7 occurred in 1982 and was associated with ground beef). Human exposure to E. coli O157:H7 is being increasingly associated with contaminated fruit, vegetables, unpasteurized milk and fruit juice, potable and recreational water, and from direct contact with animals at fairs and petting zoos.
Clinical trials have been conducted with the Company's vaccine over the past four years involving more than 30,000 cattle. Studies have consistently shown a significant decrease in the number of cattle shedding these deadly bacteria in their manure. In a controlled experiment conducted at VIDO, vaccinated cattle were challenged with a very large dose of bacteria, and there was a reduction in the magnitude of shedding by 99.47%. In clinical trials conducted by the University of Nebraska-Lincoln in commercial feedlot settings (where vaccinates and non-vaccinates were mixed), there was a 75% lower prevalence of E. coli O157:H7 in cattle vaccinated with two doses of the Bioniche vaccine. Another three-dose vaccination study was performed by the university, which showed that vaccinated cattle were 98.3% less likely to colonize the bacteria in their intestine.
About E. coli O157:H7
Escherichia coli (E. coli) bacteria are normal organisms found in the intestinal track of all animals and humans. Most E. coli are non-pathogenic (non-disease-causing) to their host, however certain strains can cause intestinal disease and, occasionally, other significant systemic disease. The E. coli O157:H7 bacterium, which was first identified in South America in the late 1970s and drifted northward, produces a powerful toxin (shiga/vero toxin) that can cause severe illness in humans and often result from consumption of contaminated food or water. Today, the bacteria can be found in most cattle herds in North America, South America, Europe and Asia. Ruminant livestock (e.g. cattle) are considered the major reservoir of E. coli O157:H7 worldwide. Numerous studies have demonstrated that the incidence of E. coli O157:H7 in beef and dairy cattle is widespread and that the organism is found in, on, and around cattle in all parts of the world. Use of manure as fertilizer for crop production and run-off from beef and dairy cattle operations are a source of contamination for the general environment, as well as surface and ground water. E. coli O157:H7 contamination of food and water as a result of fecal shedding by livestock is a well-recognized and documented threat to human health.
About E. coli O157:H7 Infection
The U.S. Centers for Disease Control estimates that E. coli O157:H7 infection affects some 73,000 people per year in the United States, and that 2% to 7% 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. The annual cost in the United States is estimated at more than $650 million due to medical expenses, lost productivity and death.
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 188 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. 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.