BELLEVILLE, Ontario -- Bioniche Life Sciences Inc. has announced that the Canadian regulator of its E. coli O157:H7 cattle vaccine has accepted the company's submission regarding the safety of an administrator in the event of an accidental needlestick while administering the vaccine to cattle.



Health Canada advised CFIA that it was their conclusion that there is no significant risk of toxicity associated with accidental self-injection by the vaccine administrator.



Health Canada had raised concerns about potential health risks associated with accidental injection of the vaccine into the administrator. In order to provide the requested data to the CFIA, Bioniche agreed to conduct an additional animal safety study. The company found published information about a piglet model, with which it conducted a small study. The data from this study were submitted to the CFIA and Health Canada for review.



"We are pleased that the concerns of the CFIA and Health Canada have been adequately addressed," said Graeme McRae, president & CEO of Bioniche Life Sciences Inc. "This clears the way for priority review of data related to our vaccine by the CFIA, as promised by the regulator last month.



"Meanwhile, we continue to see human outbreaks involving this potentially fatal bacterium, the latest occurring in the northeastern United States and potentially tied to the consumption of green onions at restaurants. The common denominator in all outbreaks is the cow."



Bioniche Life Sciences -- through the University of Nebraska-Lincoln -- is completing an efficacy study for the U.S. regulator of the E. coli O157:H7 vaccine, the USDA. This is a field challenge study, the results of which will be submitted to both the USDA and CFIA for review. The vaccine has been tested in more than 30,000 cattle in both the U.S. and Canada (through the Vaccine & Infectious Diseases Organization -- VIDO -- at the University of Saskatchewan).

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.



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.



SOURCE: Bioniche Life Sciences Inc. via PR Newswire.