BELLEVILLE, Ontario, Dec. 6 /PRNewswire-FirstCall/ -- Bioniche Life Sciences Inc. , a research-based, technology-driven Canadian biopharmaceutical company, today announced that researchers involved with its proprietary E. coli O157:H7 cattle vaccine presented clinical research results at two major international symposia.
Veterinary Vaccines Conference -- Hamburg, Germany
Dr. Dragan Rogan, Vice-President of Research & Development in the Company's Animal Health Division, presented data today at Animal Pharm's and Informa Life Sciences' Veterinary Vaccines conference in Hamburg, Germany.
Dr. Rogan noted, "Scientists around the world believe that best way to control contamination of beef products is to reduce or eliminate E. coli O157:H7 from the gut of animals in the pre-harvest period. Vaccination could decrease bacteria counts in the environment by reducing replication of bacteria in the gut of cattle" A decrease in the environmental load of E. coli O157:H7 bacteria is expected to reduce the incidence of contamination.
In Dr. Rogan's presentation, he summarized Proof of Principle studies conducted by Bioniche. These studies showed that cattle vaccination resulted in a dramatic decrease in the duration of shed, as well as a reduction in the magnitude of shedding by 2.28 logs (99.47%).
International Symposium on Shiga Toxin (Verocytotoxin)-Producing
Escherichia coli Infections -- Melbourne, Australia
The Bioniche E. coli O157:H7 vaccine was also featured at the 6th International Symposium on Shiga Toxin (Verocytotoxin) -- producing Escherichia coli infections (VTEC 2006) in Melbourne, Australia from October 29 to November 1, 2006.
Dr. David Smith, from the Department of Veterinary and Biomedical Sciences, University of Nebraska-Lincoln, presented data from a study entitled, "Effect of Regional Vaccination within the Feedyard on Escherichia coli O157:H7 Rectal Colonization, Fecal Shedding, and Hide Contamination", which had been conducted with Drs. Rodney Moxley, Terry Klopfenstein, and Galen Erickson.
The presentation outlined the results of a study testing the efficacy of regional application, within a beef cattle feedlot, of a two-dose vaccine regimen against type III secreted proteins of Escherichia coli O157:H7. Five hundred and four cattle were randomly assigned within weight strata to 63 pens within 3 treatment regions of the feedyard. Regional vaccination treatments (i.e., within regions of 21 contiguous pens per treatment) were: 1) placebo treatment with two doses of adjuvant; 2) all cattle treated with two doses of vaccine; 3) commingled vaccination with half of the cattle in the pen receiving two doses of vaccine and the others receiving two doses of adjuvant. The study concluded that the 2-dose vaccine regimen effectively reduced E. coli O157:H7 fecal shedding and hide contamination. Regional vaccination
provided greater protection against hide contamination than commingling vaccinates and non-vaccinates.
More than 30,000 cattle have been involved in studies with the Bioniche E. coli O157:H7 vaccine over the past four years, the majority of these at the University of Nebraska-Lincoln. Dr. Smith concludes, "The vaccine has been efficacious in field trials, under conditions of natural exposure to E. coli O157:H7. Pens of vaccinated cattle are less likely to be colonized with E. coli O157:H7, shed the organism in feces, have environmental exposure to the agent, or have E. coli O157:H7 contaminated hides."
E. coli O157:H7 Vaccine Regulatory Update
Bioniche Life Sciences -- through the University of Nebraska-Lincoln -- is completing a field efficacy study designed for the U.S. regulator of the E. coli O157:H7 vaccine, the U.S. Department of Agriculture (USDA).
The Canadian regulator of the E. coli O157:H7 vaccine, the Canadian Food Inspection Agency (CFIA), advised the Company on November 3, 2006 that it is proceeding with the ongoing review of the licensing documentation for this product. CFIA indicated that incoming documentation will be reviewed on a high priority basis, in collaboration with Health Canada.
Graeme McRae, President & CEO of Bioniche Life Sciences Inc. stated, "We are moving forward with regulatory approval for this important vaccine. Recent cases of E. coli O157:H7 contamination reinforce the potential danger of letting this harmful bacterial strain go unchecked. The reduction in colonization and shedding in vaccinated animals will create a significant positive impact on the environment, which will extend far beyond the cattle market."
About E. coli O157:H7
Escherichia coli (E. coli) bacteria are normal organisms found in the intestinal track 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 and drifted northward, produces a powerful toxin that can cause severe illness in humans and often result from consumption of contaminated food or water. 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 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 188 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 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 Manager, Bioniche Life Sciences Inc. Tel: 613-966-8058 ext. 1250 / Cell: 613-391-2097 Jennifer.Shea@Bioniche.com Rachel Levine, Investor Relations, The Global Consulting Group Tel: 646-284-9439 Rlevine@hfgcg.com
Bioniche Life Sciences Inc.CONTACT: Jennifer Shea, Corporate Communications Manager, Bioniche LifeSciences Inc., +1-613-966-8058 ext. 1250, cell - +1-613-391-2097,Jennifer.Shea@Bioniche.com; Rachel Levine, Investor Relations, The GlobalConsulting Group, +1-646-284-9439, Rlevine@hfgcg.com
Web site: http://www.bioniche.com/
