EconicheTM Vaccine Shows 92% Reduction in Colonization of E. coli O157 in Vaccinated Cattle
-study conducted with 21 pens of cattle in commercial feedlots-
BELLEVILLE, ON, March 13, 2009 – Bioniche Life Sciences Inc. (TSX: BNC), a research-based, technology-driven Canadian biopharmaceutical company, today announced that the results of a large-scale commercial beef feedlot study with the Company’s E. coli O157 vaccine –Econiche™ - have been published in this month’s issue of Foodborne Pathogens and Disease (Vol. 6, Number 2, 2009), a peer-reviewed scientific journal.
The article, entitled, "A Two-Dose Regimen of a Vaccine Against Type III Secreted Proteins Reduced Escherichia coli O157:H7 Colonization of the Terminal Rectum in Beef Cattle in Commercial Feedlots", was co-authored by David R. Smith, Rodney A. Moxley, Robert E. Peterson, Terry J. Klopfenstein, Galen E. Erickson, Gustavo Bretschneider, Emil M. Berberov, and Sharon Clowser.
The article summarized a large-scale clinical vaccine trial of commercially fed cattle that tested the efficacy of a two-dose regimen of the Econiche™ vaccine against type III secreted proteins of enterohemorrhagic Escherichia coli O157:H7 on the probability to detect the same organism from terminal rectal mucosa (TRM) as a measure of gut colonization. The TRM is the most significant point of colonization by E. coli O157 in cattle. Vaccine was administered to all cattle within treated pens at arrival processing and at re-implant processing. At harvest, TRM was collected from a sample of cattle from within vaccinated and non-vaccinated pens. Seven hundred eighteen cattle were tested from within 21 pens of cattle (11 vaccinated and 10 not vaccinated) representing 3,683 cattle. E. coli O157:H7 was cultured from 68 of 718 (9.5%) TRM samples. Eleven of 382 (2.9%) vaccinated cattle and 57 of 336 (17.0%) non-vaccinated cattle were TRM culture positive. From the multilevel logistic model, vaccinated cattle were 92% less likely to be colonized with E. coli O157:H7 than non-vaccinated cattle (odds ratio [OR]=0.07, p=0.0008). This is the second published study demonstrating more than 90% effectiveness of the Bioniche vaccine against colonization.
The researchers concluded that the two-dose vaccine regimen effectively reduced the probability for E. coli O157:H7 colonization of the TRM of commercially fed cattle at harvest. "As evidenced in this study, the number of days elapsing between arrival processing and reprocessing can be quite variable in typical feedlot systems," said Dr. David Smith, Extension Dairy/Beef Veterinarian, Veterinary and Biomedical Sciences, University of Nebraska–Lincoln. "However, we found no evidence that this affected vaccine efficacy. Therefore, feedlot managers may have some flexibility in scheduling re-vaccination without risking loss of efficacy. It is important that pre-harvest intervention strategies remain effective up to the time of harvest. Within the range of observations in this study, the protective effect of vaccine did not change as the number of days between reprocessing and harvest increased." This is consistent with the results from longitudinal vaccine clinical trials of the Company’s vaccine published in 2004, 2007 and 2008.
The Company’s Econiche™ vaccine is the world’s first vaccine developed to reduce the shedding by cattle of Escherichia coli (E. coli) O157:H7. Econiche™ received full licensing approval from the Canadian Food Inspection Agency (CFIA) in October, 2008 and is available for unrestricted use by Canadian cattle producers and their veterinarians.
The USDA cleared the path for a conditional license for the vaccine in February, 2008, and the Company in the process of completing the required manufacturing steps in the U.S. at this time.
Econiche™ is a Canadian discovery developed by Bioniche Life Sciences Inc. The vaccine has the potential to significantly reduce the amount of E. coli O157 shed into the environment by beef and dairy cattle and, in turn, reduce the risk to human health. Most strains of E. coli are harmless but some, like O157:H7, can cause severe illness and even be fatal when ingested by humans from contaminated meat, vegetables or water. Vaccination of cattle with Econiche™ can help reduce the risk of food and waterborne contamination with E. coli O157:H7.
"Cows carry E. coli O157:H7 but they don’t get sick. Where the disease manifests itself is people encountering contaminated food or water, usually from cow feces," said Dr. Brett Finlay, University of British Columbia microbiologist and bacterial diseases expert, whose research led to the development of the vaccine. "If we block the colonization of cows by O157, we basically decrease the number that humans are exposed to, and thus, dropping the disease levels in humans."
On-farm interventions to reduce the shedding of E. coli O157:H7 by cattle, such as simple vaccination of cattle with Econiche™, have the potential to reduce food and water contamination and the consequences associated with human infection with the deadly bacteria. Clinical trials conducted with Econiche™ have shown a significant reduction in the amount of E. coli,/i> shed in the manure of vaccinated cows.
Human exposure and infection with E. coli O157:H7 can result in serious health consequences, including abdominal pain and severe bloody diarrhea. In severe cases, kidney damage can occur and progress to serious complications and even death.
Econiche™ is manufactured in the Bioniche production facility in Belleville, Ontario, where a $25-million expansion is taking place, supported by the Ontario and Canadian governments. Vaccine supply will be limited during this manufacturing expansion period.
About E. coli O157:H7
An estimated 100,000 cases of human infection with the E. coli O157:H7 organism are reported each year in North America. Two to seven per cent of those people develop haemolytic 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.
In addition to being infected by contaminated food or water, individuals can become infected from E. coli O157:H7 by visiting animal exhibits. Petting zoos, fairs, and agricultural exhibits provide many possible routes of transmission for E. coli. Direct animal contact is the obvious route, but contact with contaminated products (e.g., sawdust, shavings, soiled clothing or shoes) can also lead to human infection.
Econiche™ received international recognition in September 2007 by the Animal Pharm Industry Excellence Awards as the best new veterinary product for livestock globally. 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,/i> O157 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 six years.
Two articles were published in a peer-reviewed journal, the Journal of Food Protection, with regard to the efficacy of Econiche™. These articles were related to field challenge studies conducted at the University of Nebraska-Lincoln involving close to 900 animals in 2002 and 2003. Among the findings by researchers Dr. David Smith and Dr. Rod Moxley et al: 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". Another article was published in the Vol. 5, Number 5, 2008 issue of Foodborne Pathogens and Disease outlining the outcome of a clinical vaccine trial of commercially fed cattle that tested the effect of a two-dose regimen of Econiche™ against type III secreted proteins of enterohemorrhagic Escherichia coli (E. coli) O157:H7 on the probability of detecting the organism on environmental sampling devices.
About Foodborne Pathogens and Disease
This peer-reviewed, international journal publishes original papers and short communications on research and diseases caused by foodborne pathogens. Topics include emerging pathogens; emergence of drug resistance; methods and technology for rapid and accurate detection; strategies to destroy or control foodborne pathogens in food production and processing; and development of novel strategies for the prevention and control of plant and animal diseases that impact food safety. The Journal includes timely reviews and special reports on topics such as agro-terrorism and the safety of organically grown and genetically modified foods.
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 200 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. Bioniche has been named one of the Top 50 Best Small and Medium-Sized Employers in Canada for 2009. 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, Vice-President, Communications, Investor & Government Relations
Bioniche Life Sciences Inc.
Telephone: (613) 966-8058
Cell: (613) 391-2097