Epitopix has won approval from federal regulators to sell the first animal vaccine in the United States to combat a deadly strain of E. coli bacteria.
The Willmar, Minn.-based start-up, a spin-off of Willmar Poultry Co., won a conditional license from the United States Department of Agriculture (USDA) to start selling the vaccine to cattle producers and beef processors. A conditional license means a company can market the product but that the USDA still requires additional safety and efficacy tests.
"It's extremely significant," said Epitopix general manager Jim Sandstrom. "This is a very, very big thing for us."
Epitopix's vaccine is designed to reduce the amount of the pathogens associated with E. coli O157 in the intestines of cattle, helping to prevent the deadly bacteria from contaminating human food. According to field studies conducted by Epitopix and reviewed by the USDA, the vaccine reduced the number of cattle testing positive for the bacteria by 85 percent. Of the animals that did test positive for E. coli, the vaccine eliminated 99 percent of the bacteria.
"Those are impressive numbers," said Michael Doyle, director of the University of Georgia's Center for Food Safety. "That would be a beneficial treatment for meat producers. We need treatments like this." Doyle is not connected to Epitopix.
E. coli O157 infects about 70,000 people each year, according to the Centers for Disease Control.
The bacteria, which live in intestines of cattle, infect humans who inadvertently consume animal feces found in finished products such as ground beef. E. coli O157 causes stomach cramps, bloody diarrhea and vomiting and can lead to kidney damage and death. There are few, if any, direct treatments for patients; antibiotics have proved largely ineffective, the CDC says.
After a decade of declines, E. coli cases have been on the rise since 2005. In 2007, companies recalled more than 30 million pounds of ground beef. At least 65 illnesses, but no deaths, were linked to those recalls. Last year, Westland/Hallmark Meat Co., based in Chino, Calif., pulled 143 million pounds of beef off the market, the largest beef recall in history.
Preventing E. coli from seeping into the human food supply has long vexed the $74 billion beef industry. Until recently, beef producers focused on rigorous monitoring, cleaning and testing of animal parts, as well as consumer education. Some companies have developed more high-tech solutions, including feeding cattle "good" bacteria to neutralize the E. coli pathogens and the use of vaccines to protect humans and cattle.
In 2006, Bioniche Life Sciences in Canada introduced the world's first vaccine against E. coli 0157 in cattle but has not yet received approval in the United States.
How it works
Epitopix's "siderophore receptor and porin (SRP)" vaccine trains the body's immune system to target and destroy protein receptors located on the outer membranes of bacteria that otherwise would steal iron from the host. Bacteria need iron to survive, so denying them iron by eliminating the proteins theoretically would kill the pathogen and prevent infection.
Many types of bacteria contain identical protein receptors, so Epitopix's SRP vaccine could theoretically work against many diseases. In 2004, Epitopix spun off Syntiron to apply the technology for human use. Syntiron won a $3.8 million contract this month from the U.S. Defense Department to combat bioterrorism-related diseases, including anthrax and bubonic plague.
Sandstrom of Epitopix says he hopes the vaccine will be ready by the summer, the peak season for cattle slaughter. The company estimates the vaccine will eventually protect 10 million cattle on animal feed a year, or a quarter of the country's annual cattle supply. Epitopix is in talks to partner with major drug manufacturers like Pfizer Inc. and Novartis AG.
One of the country's largest beef producers has already agreed to purchase the vaccine, said Sandstrom, who declined to name the customer.
Cargill Inc., Tyson Foods Inc., and Smithfield Foods Inc. are among the nation's top meat processors.
Thomas Lee • 612-673-7744