Most Effective Strategy for Managing E. coli O157:H7 in Beef is a Combination of a Pre-Harvest Intervention and Several Processing Interventions

-Public Health Agency of Canada study evaluated the effects of various interventions-

BELLEVILLE, ON, May 28, 2012 /PRNewswire/ - Bioniche Life Sciences Inc. (TSX: BNC) (ASX: BNC), a research-based, technology-driven Canadian biopharmaceutical company, today announced that a Public Health Agency of Canada study assessing the effects of various interventions on the management of E. coli O157:H7 in Canadian beef came to a favourable conclusion with regard to pre-harvest vaccines such as the Company's EconicheTM cattle vaccine. The study, "A risk assessment model for Escherichia coli O157:H7 in ground beef and beef cuts in Canada: Evaluating the effects of interventions", has been accepted for publication in an upcoming issue of Food Control (2012) and is now available on-line. Its authors are Ben A. Smith, Aamir Fazil and Anna M. Lammerding, all of whom work in the Science to Policy Division, Laboratory for Foodborne Zoonoses, Public Health Agency of Canada.

In their study, the three researchers developed a stochastic, quantitative risk assessment model to evaluate the public health risks associated with consumption of ground beef and beef cuts contaminated with Escherichia coli (E. coli) O157:H7 in Canada. The researchers evaluated the relative effects of pre-harvest and processing interventions on public health risks, comparing the baseline risks from consumption of beef products.

The research included findings from critical systematic review and meta-analysis of published literature, and 20 different intervention scenarios were assessed. The pre-harvest interventions that were assessed included probiotics, an SRP vaccine, and a Type III protein vaccine. Production/processing interventions that were analyzed included hot water wash, steam pasteurization, acid spray chill, dry-aged chill, and water spray chill. The researchers concluded that the most effective strategy for E. coli O157:H7 management includes a pre-harvest intervention and several processing interventions: "Specifically, application of Type III secreted protein vaccination along with a suite of processing interventions … provided the greatest relative reduction in risks." The Company's EconicheTM vaccine is a Type III protein vaccine.

The findings from this study support the Company's ongoing efforts to gain widespread uptake of cattle vaccination with EconicheTM.

EconicheTM Regulatory/Market Update

Since October, 2008, the Company has had a full license for its cattle vaccine against E. coli O157 - EconicheTM - in Canada. In the intervening period, there has been limited uptake by Canadian cattle producers. Those who have adopted the technology have been small producers who have a branded beef product and are concerned about the negative impact of an E. coli outbreak on their brand, and those producers/farmers whose cattle have infected humans with E. coli O157. Outbreaks and recalls associated with E. coli O157 infection and contamination continue to occur on a regular basis, so this public health threat remains a grave concern.

In February, 2008, the Company was advised by the United States Department of Agriculture (USDA) that EconicheTM was eligible for a conditional license once certain conditions were met. Since that time, the Company has been in regular dialogue with USDA officials about this license.

Most recently, the USDA's Center for Veterinary Biologics issued updated guidance regarding the licensing of vaccines as pre-harvest food safety interventions. Company representatives look forward to discussing this new guidance with the USDA, to collaboratively reach consensus on the path to vaccine licensing in the U.S.

About E. coli O157

Ruminants, primarily cattle, are considered to be the primary carriers of E. coli O157. This bacterium 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. Among the many outbreaks recorded, a 1996 Japanese outbreak made more than 9,000 people sick while the Walkerton, Ontario outbreak in 2000 sickened 2,500. A late April E. coli outbreak in New Brunswick has sickened up to 27 residents, many of whom ate at a Jungle Jim's restaurant.

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 and innovative 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 and commercialize products that advance human or animal health and increase shareholder value.

Bioniche Life Sciences Inc. has been named one of the Top 50 Best Small and Medium-Sized Employers in Canada for 2011. 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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