Bioniche Life Sciences Experiences Significant Trading Volume Following Progress Update on E. Coli O157:H7 Cattle Vaccine Canadian Regulatory Status
Posted on: Friday, 15 December 2006, 09:01 CST
BELLEVILLE, Ontario, Dec. 15 /PRNewswire-FirstCall/ -- Bioniche Life Sciences Inc. (TSX: BNC), a research-based, technology-driven Canadian biopharmaceutical company, has taken note of a significant increase in volume of trading of its shares over recent trading days. The Company has no undisclosed reportable developments. It continues to pursue its strategic priorities: the completion of its Phase III trials with its proprietary Mycobacterial Cell Wall-DNA Complex (MCC) -- trademarked Urocidin -- in bladder cancer; and the licensing of its E. coli O157:H7 cattle vaccine. At the same time, the Company continues to work toward completing a partnership deal to support its Phase III development program for Urocidin; raising additional debt, preferred or common equity; and finding strategic financing partners to support the animal health business.
The increased trading volume began following the Company's announcement last week 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 the Canadian Food Inspection Agency (CFIA) that it was their conclusion that there is no significant risk of toxicity associated with accidental self-injection by the vaccine administrator.
Recent outbreaks of E. coli O157:H7 affecting spinach and other produce in North America have highlighted the fact that this is an increasingly serious human health threat that goes beyond meat (the first major foodborne outbreak of E. coli O157:H7 occurred in 1982 and was associated with ground beef). Human exposure to E. coli O157:H7 is being increasingly associated with contaminated fruit, vegetables, unpasteurized milk and fruit juice, potable and recreational water, and from direct contact with animals at fairs and petting zoos.
Clinical trials have been conducted with the Company's vaccine over the past four years involving more than 30,000 cattle. Studies have consistently shown a decrease in the number of cattle shedding these deadly bacteria in their manure. In a controlled experiment conducted at the Vaccine and Infectious Diseases Organization (VIDO) at the University of Saskatchewan, vaccinated cattle were challenged with a very large dose of bacteria, and there was a reduction in the magnitude of shedding by 99.47%. In clinical trials conducted by the University of Nebraska-Lincoln in commercial feedlot settings (where vaccinates and non-vaccinates were mixed), there was a 75% lower prevalence of E. coli O157:H7 in cattle vaccinated with two doses of the Bioniche vaccine. Another three-dose vaccination study was performed by the university which showed that vaccinated cattle were 98.3% less likely to colonize the bacteria in their intestine.
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 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 Centres 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 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/
Source: PRNewswire-FirstCall
Related Articles
- Econiche(TM) Vaccine Shows 92% Reduction in Colonization of E. coli O157 in Vaccinated Cattle
- USD 12.5 m Funding for the Development of Intercell's Vaccine Patch System for Pandemic Influenza From U.S. Department of Health and Human Services (HHS)
- Canadian Regulator Recognizes Efficacy and Safety of Bioniche E. Coli O157 Cattle Vaccine
- Bioniche Presents E. Coli O157
- Bioniche Hosts Veterinarians and Food Industry Reps at Two-Day E. Coli O157:H7 Vaccine Conference
- Soliant Health Makes Second Annual Contribution to Georgia State University College of Health and Human Sciences
- Bioniche E. Coli O157:H7 Cattle Vaccine Authorized for Field Use in Canada
- Soliant Health Contributes to Georgia State University College of Health and Human Sciences
- Die-Off of Pathogenic E. Coli O157:H7 in Sewage Contaminated Waters1
- Not All Inflammation in the Right Lower Quadrant Is Appendicitis: A Case Report of Escherichia Coli O157:H7 With a Review of the Literature
User Comments (0)

RSS Feeds