World's First Cattle Vaccine to Reduce E. coli O157 Threat Receives Full Licensing Approval...(orldwide commercialization of the vaccin...),Health

Date:10/27/2008

orldwide 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.

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 recently published in 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.

U.S. Regulatory Status

Bioniche Life Sciences Inc. is concurrently working to meet the requirements for a U.S. conditional license for Econiche. The United States Department of Agriculture (USDA) informed the Company in February of this year that the latest data for Econiche "meets the 'expectation of efficacy' standard" and is eligible for a conditional license, providing that the Company develops a plan "that would collect sufficient data to move the product to full licensure". The conditional license, when granted, will provide the Company full access to the U.S. market with two restrictions: At least one step in the manufacturing process must be performed in t
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SOURCE Bioniche Life Sciences Inc. Copyright©2008 PR Newswire. All rights reserved

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