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Biological Agents
Journal of Food Protection Publishes Two Articles on E. coli O157:H7 Vaccine Efficacy
By Bioniche Life Sciences Inc.
Nov 13, 2007 - 7:16:51 AM

- articles published in November, 2007 issue -

BELLEVILLE, ON, November 13, 2007 – Bioniche Life Sciences Inc. (TSX: BNC), a research-based, technology-driven Canadian biopharmaceutical company, today announced that two articles have been published in a peer-reviewed journal, the Journal of Food Protection, both in regards to the efficacy of the Company’s E. coli O157:H7 cattle vaccine. The two articles relate to field challenge studies conducted at the University of Nebraska-Lincoln involving close to 900 animals in 2002 and 2003.

The first article, “Efficacy of dose regimen and observation of herd immunity from a vaccine against Escherichia coli O157:H7 for feedlot cattle” (R.E. Peterson, T.J. Klopfenstein, R.A. Moxley, G.E. Erickson, S. Hinkley, D. Rogan, and D.R. Smith), supports the hypothesis that use of the Bioniche vaccine effectively reduces the likelihood of cattle shedding E. coli O157:H7. After a three-dose treatment, vaccinated cattle were significantly less likely (73%) to shed the organism than unvaccinated cattle (P<0.0001). The same study noted that there was no indication of affect on (feed conversion) performance or carcass quality, and that 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”.

The second article, “Effect of a vaccine product containing type III secreted proteins on the probability of Escherichia coli O157:H7 fecal shedding and mucosal colonization in feedlot cattle” (R.E. Peterson, T.J. Klopfenstein, R.A. Moxley, G.E. Erickson, S. Hinkley, G. Bretschneider, E.M. Berberov, D. Rogan, and D. R. Smith), highlights the results of a study that looked at the effect of vaccination on the shedding of E. coli O157:H7 by cattle and their colonization by the organism. Vaccinated cattle were 98.3% less likely to be colonized by E. coli O157:H7 at the terminal rectum (where the bacteria are known to collect and reproduce in large quantities). Specifically, the authors were able to isolate E. coli O157:H7 from only one of 140 vaccinated cattle, versus 38 of 141 non-vaccinates (P<0.0001).

“These two peer-reviewed journal publications substantiate the efficacy of the Bioniche vaccine,” said Dr. Dragan Rogan, Vice-President, Animal Health Research & Development at Bioniche Life Sciences Inc. “Not only has the vaccine substantially reduced the amount of E. coli O157:H7 shed by cattle into the environment, it has reduced the likelihood that cattle are colonized by the organism, thus reducing the reproduction of new bacteria and thereby lowering overall bacterial load in a feedlot environment.”

It remains very clear that there is a pressing need to reduce the amount of E. coli O157:H7 shed into the environment by cattle. Food recalls continue to occur on a massive scale in beef, produce and prepared food: Just from September, E. coli O157:H7-related recalls have totalled 22.7 million pounds of beef, packaged greens and five million frozen pizzas. Pre-harvest 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.

About the Journal of Food Protection

The Journal of Food Protection provides up-to-date, original research reports in food science and technology. First published in 1937, the Journal of Food Protection is a refereed monthly publication. Each issue contains scientific research and authoritative review articles reporting on a variety of topics in food science pertaining to food safety and quality. The journal is internationally recognized as the leading publication in the field of food microbiology with a readership exceeding 11,000 scientists from 69 countries. The Journal of Food Protection is indexed in Index Medicus, Current Contents, BIOSIS, PubMed, Medline, and many others.  The journal can be found on-line at www.foodprotection.org/publications/jfp.asp .

About E. coli O157:H7

Escherichia coli ( E. coli) bacteria are normal organisms found in the intestinal tract 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 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. 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 195 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.

For further information, please contact:

Jennifer Shea, Corporate Communications & Investor Relations Manager

Bioniche Life Sciences Inc.

Telephone: (613) 966-8058

Cell: (613) 391-2097

Jennifer.Shea@Bioniche.com






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