July 28, 2009

Bioniche Life Sciences Inc. a research-based, technology-driven Canadian biopharmaceutical company, announced that the results of two large-scale commercial beef feedlot studies with the company's Escherichia coli (E. coli) O157 vaccine - Econiche(TM) - were positive and 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, Faecal Shedding, and Hide Contamination", was co-authored by David R. Smith, Rodney A. Moxley, Terry J. Klopfenstein, and Galen E. Erickson.

 

This article summarises 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. More than 500 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). Faecal 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 faecal shedding, regional vaccine efficacy of the ALLVAC group compared to the NOVAC pens was 63 percent (OR=0.34, p=0.0009), similar to vaccine efficacy of 52 percent for vaccinated cattle compared to placebo-treated cattle within HALFVAC pens (OR=0.48, p=0.014). For hide contamination, vaccine efficacy was 55 percent 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 faecal shedding and hide contamination, and that cattle vaccination 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 states 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 faeces 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 faeces 65 percent 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 faecal shedding, and agree with the researchers' previous finding that efficacy of two or three doses of the vaccine exhibit a dose response.

 

Dr. Dragan Rogan, Vice-President, Animal Health Research Development at Bioniche Life Sciences Inc said the articles "further substantiate the efficacy of Econiche". Rogan said that not only has the vaccine substantially reduced the amount of E. coli O157 shed by cattle into the environment, it has also 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 Econiche vaccine 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) has approved the conditional license for the vaccine in February 2008, and the Company is in the process of completing the required manufacturing steps in the US 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 diarrhoea. 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 US have been infected with E. coli O157:H7, with 35 of these hospitalized and 11 with Haemolytic Uremic Syndrome (HUS).

 

Econiche is manufactured in the Bioniche production facility in Belleville, Ontario, where a C$25-million (US$23.20 million) expansion is taking place, supported by the Ontario and Canadian governments. Vaccine supply will be limited during this manufacturing expansion period.