-final study leading to full Canadian license for the vaccine-
BELLEVILLE, ON, May
The article, entitled, "Vaccination with type III secreted proteins leads to decreased shedding in calves after experimental infection with Escherichia coli O157", was co-authored by Kevin J. Allen, Dragan Rogan, B. Brett Finlay, Andrew A. Potter, David J. Asper. This article summarized a controlled challenge study conducted in early 2008 at the Vaccine and Infectious Disease Organization (VIDO) - University of Saskatchewan which was the final study that led to the full Canadian license for EconicheTM from the Canadian Food Inspection Agency (CFIA) in October, 2008.
The controlled challenge study at VIDO involved 30 placebo-treated cows and 30 vaccinated cows. The vaccinated cows each received three doses of EconicheTM. Both groups were then infected with E. coli O157 and fecal shedding was monitored daily for a two-week period. These data indicate that EconicheTM vaccination had protective effects through significant reductions in both the number of animals shedding and the number of challenge organisms shed per animal. The authors of the article summarized the study by saying it provides evidence that vaccination with EconicheTM is an effective pre-harvest intervention strategy against E. coli O157.
These data constitute part of the Company's international regulatory dossier in such jurisdictions as Australasia, Europe, Scandinavia, and South America. The Company has been actively exploring opportunities to introduce EconicheTM to markets beyond North America, where it has a full license (Canada) and a pending conditional license (U.S.).
EconicheTM will be manufactured in the Company's newly completed Animal Health and Food Safety Vaccine Manufacturing Centre in Belleville, Ontario, currently undergoing validation and commissioning. Full production in the new Centre is expected to begin by the fall of 2011.
About the Bioniche E. coli O157 Vaccine (EconicheTM)
The Food Safety Division of Bioniche Life Sciences Inc. has worked with Canadian university researchers, in particular, inventor Dr. Brett Finlay and his team at the University of British Columbia, to develop and license a cattle vaccine against E. coli O157. This vaccine - trademarked EconicheTM - is meant to reduce the level of the bacterium in water, food and the environment and, in turn, reduce the potential infection of humans.
EconicheTM has the potential to significantly reduce the amount of E. coli O157 shed into the environment by beef and dairy cattle. This organism does not cause illness in cattle, but cattle are the primary reservoir for it. Vaccination of cattle with EconicheTM can help reduce the risk of food and waterborne contamination with E. coli O157.
EconicheTM has been developed by a strategic alliance formed in September, 2000 and composed of the University of British Columbia (UBC), the Alberta Research Council (ARC), the University of Saskatchewan's Vaccine and Infectious Disease Organization (VIDO), and Bioniche, which holds the rights for worldwide commercialization of the vaccine.
More about E. coli O157
The E. coli O157 organism causes no disease in cattle, but cattle are the primary reservoir for it. E. coli O157 can cause severe illness and can even 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 diarrhea. In severe cases, kidney damage can occur and progress to serious complications and even death. Lingering, long-term medical conditions can persist in individuals exposed to the bacterium. These include post-infectious irritable bowel syndrome (PI-IBS), reduced kidney function, diabetes, hypertension and reactive arthritis.
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 uremic syndrome (HUS), a disease characterized by kidney failure. Five percent of HUS patients die, many of them children and senior citizens, whose kidneys are more sensitive to damage.
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 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 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.
SOURCE Bioniche Life Sciences Inc.
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