EconicheTM Vaccine Efficacy Summarized in July Issue of Foodborne Pathogens and Disease
-two articles published in this peer-reviewed scientific journal-
BELLEVILLE, ON, July 17, 2009 – Bioniche Life Sciences Inc. (TSX: BNC), a research-based, technology-driven Canadian biopharmaceutical company, today announced that the results of two large-scale commercial beef feedlot studies with the Company’s Escherichia coli (E. coli) O157 vaccine –EconicheTM - have been published in this month’s issue of Foodborne Pathogens and Disease (Vol. 6, Number 7, 2009), a peer-reviewed scientific journal.
The article, entitled, “A Randomized Longitudinal Trial to Test the Effect of Regional Vaccination Within a Cattle Feedyard on Escherichia coli O157:H7 Rectal Colonization, Fecal Shedding, and Hide Contamination”, was co-authored by David R. Smith, Rodney A. Moxley, Terry J. Klopfenstein, and Galen E. Erickson.
This article summarized a large-scale clinical vaccine trial of commercially fed cattle in 2005 that tested the efficacy of vaccinating all cattle in within the feedyard using a two-dose regimen of Econiche. 504 cattle were randomly assigned to 63 pens within three treatment regions of the feedyard. One group received two doses of vaccine (ALLVAC); a second group received two doses of adjuvant as placebo (NOVAC); and in a third group, half received two doses of vaccine, while the other half received adjuvant (HALFVAC). Fecal shedding of E. coli O157:H7 was measured at 42, 63, and 84 days post-vaccination. Hide contamination was measured 42, 63, and 84 days post-vaccination at the feedyard, then on day 85 at the abattoir (meat processor). Colonization of the terminal rectal mucosa was also measured on day 85 at the abattoir.
For fecal shedding, regional vaccine efficacy of the ALLVAC group compared to the NOVAC pens was 63% (OR=0.34, p=0.0009), similar to vaccine efficacy of 52% for vaccinated cattle compared to placebo-treated cattle within HALFVAC pens (OR=0.48, p=0.014). For hide contamination, vaccine efficacy was 55% for regional vaccination in ALLVAC pens compared to NOVAC pens (OR=0.43, p=0.014). Co-mingling of vaccinated and placebo-treated cattle was not protective of hide contamination (OR=0.67, p=0.33). Colonization of cattle at the abattoir was not different among vaccinated and placebo-treated cattle (p=0.63).
The researchers concluded that the two-dose vaccine regimen effectively reduced E. coli O157:H7 fecal shedding and hide contamination, and that vaccination of cattle within regions of the feedyard provided greater protection against hide contamination than commingling vaccinates and non-vaccinates.
The second article, entitled, “Escherichia coli O157:H7 Vaccine Dose-Effect in Feedlot Cattle”, was co-authored by Rodney A. Moxley, David R. Smith, Matt Luebbe, Galen E. Erickson, Terry J. Klopfenstein, and Dragan Rogan.
This article summarized a clinical trial conducted in 2006, which evaluated the effects of two- and three-dose regimens of the Econiche vaccine on the probability of detecting E. coli O157:H7 in feces and colonization of the terminal rectum.
The researchers concluded that the three-dose regimen significantly reduced the probability for cattle to shed E. coli in feces 65% compared to placebo-treated cattle. A dose-effect was demonstrated because a two-dose regimen of the vaccine product was intermediate in effect. These results are consistent with previous estimates of vaccine efficacy against fecal shedding, and agree with the researchers’ previous finding that efficacy of two or three doses of the vaccine exhibit a dose response.
“These two peer-reviewed publications further substantiate the efficacy of Econiche,” said Dr. Dragan Rogan, Vice-President, Animal Health Research & Development at Bioniche Life Sciences Inc. “Not only has the vaccine substantially reduced the amount of E. coli O157 shed by cattle into the environment, it has reduced the likelihood that cattle are colonized by the organism, thus reducing the reproduction of new bacteria and thereby lowering overall bacterial load in a feedyard environment.”
The Company’s Econichevaccine is the world’s first vaccine developed and licensed to reduce the shedding by cattle of E. coli O157. 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 United States Department of Agriculture (USDA) cleared the path for a conditional license for the vaccine in February, 2008, and the Company is 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.
On-farm interventions to reduce the shedding of E. coli O157 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.
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. In one of the reported outbreaks, in Nestle Toll-House cookie dough, 76 persons from 31 states in the U.S. have been infected with E. coli O157:H7, with 35 of these hospitalized and 11 with Haemolytic Uremic Syndrome (HUS) (see below).
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 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.
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