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Bioniche E. Coli O157:H7 Vaccine Discussed at 4th International Conference on Vaccines for Enteric Diseases

Posted on: Monday, 30 April 2007, 18:00 CDT

BELLEVILLE, Ontario, April 30 /PRNewswire-FirstCall/ -- Bioniche Life Sciences Inc. (TSX: BNC), a research-based, technology-driven Canadian biopharmaceutical company, presented data at the 4th International Conference on Vaccines for Enteric Diseases, held last week in Lisbon, Portugal. Dr. Dragan Rogan, Vice-President of Animal Health Research & Development with Bioniche Life Sciences Inc. presented a paper entitled, "Vaccination reduces shedding and colonization of E. coli O157:H7 in cattle", which was co-authored by Dr. Andrew Potter, Vaccine and Infectious Disease Organization (VIDO) - University of Saskatchewan, Dr. David Smith, University of Nebraska-Lincoln, and Colin Strauss, Bioniche Life Sciences Inc.

In his presentation, Dr. Rogan noted that enterohaemorrhagic Escherichia coli O157:H7 (EHEC) is an important pathogen of humans for which cattle are an important reservoir and the main source of illness, either through direct contact such as petting zoos or consumption of contaminated meat products; or indirectly, through consumption of fruits and vegetables which have been irrigated with contaminated water.

Dr. Rogan suggested that the prevalence of E. coli O157:H7 in cattle herds varies substantially, but is highest during the summer months (as high as 80%), which can lead to as many as half of the carcasses becoming contaminated in the slaughter plant. This increased summer prevalence coincides with increased rates of ground beef contamination and the increased incidence of human infections reported during the summer.

"Pre-slaughter interventions represent a promising means of reducing the risk of human infection," said Dr. Rogan. "Simulation models have demonstrated that reducing the number of bacteria in pre-slaughter cattle would be the best way to reduce EHEC incidence of disease in humans. To that end, several approaches have been evaluated at the feedlot level such as changes to animal husbandry practices, modification of feed rations, feeding of probiotics, antibiotics, and bacteriophages. To date however, vaccination appears to be the single most effective method of reducing E. coli O157:H7 at the feedlot level."

Controlled challenge studies demonstrated that vaccination with Bioniche's E. coli O157:H7 Type III Secreted Protein (TTSP) vaccine (3 doses, 3 weeks apart) resulted in a 36.5% reduction in the number of days the bacterium was shed in the feces (P<0.05), and a 2.28 log10 reduction in the number of bacteria being shed in the feces; resulting in a vaccine efficacy of more than 99%.

The efficacy of Bioniche's vaccine was also evaluated under feedlot (field) conditions where cattle are naturally exposed to high levels of E. coli O157:H7 during the summer months. The most recent of these for which published data is available were conducted in 2004. 144 cows were vaccinated, and these animals were less likely to be colonized by E. coli O157:H7 in the mucosa of the terminal rectum as compared to the placebo group. A large-scale feedlot study was also conducted in 2004 across nineteen commercial feedlots (n=20,556 vaccinates) to evaluate the efficacy of only 2 vaccinations, upon entry and again at re-implantation. This study demonstrated that, as compared to unvaccinated cattle on a pen basis, vaccinated cattle had a 75% lower probability for being colonized by E. coli O157:H7 and were less likely to test ROPES-positive (ropes were hung over the feed bunks as a means of assessing environmental contamination by means of cattle saliva), indicating that the vaccine reduced environment exposure of cattle to E. coli O157:H7.

While it is clear that the reduction of E. coli O157:H7 in the feedlot and the environment is best achieved by reducing the shedding of the organism in the feces, there are some researchers who believe that E. coli O157:H7 contamination of abattoir facilities comes predominately from the hides as opposed to the intestinal waste. In order to evaluate the effect of Bioniche's vaccine on hide contamination a feedlot study was conducted in 2005 (n=168 vaccinates) in which it was demonstrated that the hides of vaccinated animals were 58% less likely to be contaminated than animals received the placebo (p=0.01).

"We have seen consistent results in both field and challenge studies which demonstrate that the Bioniche E. coli O157:H7 vaccine is effective in reducing the amount of this bacteria shed into the environment," added Dr. Rogan.

The Company is scaling up production of the vaccine at its Belleville, Ontario, Canada facility in anticipation of commercial launch of the vaccine in Canada in July of this year. The Company received authorization from the Canadian Food Inspection Agency in December, 2006 to make the vaccine available to veterinarians under a Permit to Release Veterinary Biologics. The Company is pursuing full registration in both Canada and the U.S.

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 185 skilled personnel and has three operating business units: 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 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.

For further information, please contact: Jennifer Shea Corporate Communications & Investor Relations Manager Bioniche Life Sciences Inc. Telephone: (613) 966-8058 ext. 1250 Cell: (613) 391-2097 Jennifer.Shea@Bioniche.com

Bioniche Life Sciences Inc.

CONTACT: Jennifer Shea, Corporate Communications & Investor RelationsManager of Bioniche Life Sciences Inc., +1-613-966-8058 ext. 1250,+1-613-391-2097 mobile, Jennifer.Shea@Bioniche.com

Web site: http://www.bioniche.com/

Source: PRNewswire-FirstCall

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