July 10, 2008
Bioniche Presents E. Coli O157
BELLEVILLE, ON, July 10 /PRNewswire-FirstCall/ -- Bioniche Life Sciences Inc. (TSX: BNC), a research-based, technology-driven Canadian biopharmaceutical company, presented data regarding its E. coli O157:H7 cattle vaccine at the XXV World Buiatrics Congress in Budapest, Hungary today. The presentation was made by Dr. Dragan Rogan, Vice-President, Bioniche Animal Health Research & Development. It was entitled, "Vaccination of Cattle with E. coli O157:H7 Type III Secretion Proteins as a Pre-Slaughter Intervention Method to Reduce E. coli O157:H7 Prevalence", and was co-authored by Dr. David Smith, Dr. Rod Moxley, Dr. Andy Potter and Julie Yome.
The World Buiatrics Congress is the largest event of its kind in the cattle industry, and is attended by scientists from universities and research institutes, practitioners working with dairy and beef cattle and other ruminants, consultants, post-docs, PhDs and graduate students of veterinary medicine and animal science from around the world.The Bioniche vaccine is the world's first vaccine that may be used as an on-farm intervention to reduce the amount of E. coli O157:H7 shed by cattle. Bioniche and its collaborators have been moving the vaccine towards commercial availability for eight years and it has been extensively tested at the University Nebraska-Lincoln, with efficacy results now being published in peer-reviewed scientific journals, most recently, the Journal of Food Protection, in November, 2007.
In his presentation in Budapest, Dr. Rogan summarized numerous studies that have been completed with the Bioniche vaccine over the last five years involving more than 30,000 cattle. In one study, calves were vaccinated with three doses and challenged with E. coli O157:H7 14 days later. There was a 2.28 log10 reduction in the magnitude of shedding in vaccinated animals compared to controls. In another study, with a three-dose vaccination and natural exposure to E. coli O157:H7, vaccinated animals were less likely to be colonized by the bacteria in the mucosa of the terminal rectum at harvest (OR=0.014, p<0.0001), resulting in a vaccine colonization efficacy of 98.3%. A two-dose vaccination was used to evaluate hide contamination in the feedlot. Hides were sampled for E. coli O157:H7 contamination twice in the feedlot and immediately before and after animals were shipped to the abattoir. This same study also found a statistically significant reduction in the likelihood of vaccinated animals having contaminated hides. Additionally, pen-level prevalence following a two dose vaccination was assessed in a feedlot study. Vaccinated pens were less likely than unvaccinated pens to test positive (OR=0.59, p<0.004) using the ROPES method.
"These results provide compelling evidence that vaccination of cattle with the Bioniche E. coli O157:H7 cattle vaccine has the potential to be an effective pre-slaughter intervention for the reduction of E. coli O157:H7 shedding, colonization, hide contamination, and pen-level prevalence," concluded Dr. Rogan.
Food recalls due to E. coli O157:H7 contamination continue to be a concern in beef, produce and prepared food. On-farm interventions to reduce the shedding of E. coli O157:H7 by cattle, such as vaccination, may assist in reducing the potential for food and water contamination and the resulting human illnesses and deaths.
Approximately 100,000 cases of human infection with the E. coli O157:H7 organism are reported each year in North America. 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.
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.
The E. coli O157:H7 cattle vaccine will be manufactured in the Bioniche production facility in Belleville, Ontario, Canada where a two-year, $25 million expansion is taking place, supported by the Ontario and Canadian governments. Vaccine supply will be limited during this manufacturing expansion period.
About the E. coli O157:H7 Cattle Vaccine
This 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:H7 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 five years.
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, Corporate Communications, Investor & GovernmentRelations Director, Bioniche Life Sciences Inc., Telephone: (613) 966-8058,Cell: (613) 391-2097, [email protected]