FDA Oks Spray-On Virus Additives for Meat Written by Rita Jenkins| 20 August, 2006 04:38 GMT The FDA has approved a spray-on mixture of bacteria-killing viruses as additives to cold cuts, wieners and sausages to destroy Listeria microbes, which kill hundreds of people in the US each year. The latest US-approved additive to ready-to-eat lunchmeat and poultry products is a combination of six bacteriophages -- parasitic viruses that destroy the Listeria monocytogenes bacterium, which sickens thousands and kills hundreds of people each year.
The Food and Drug Administration on Friday declared the virus mix safe to spray on such foods as cold cuts, hot dogs, sausages, sliced ham and turkey prior to packaging.
Foods like these are especially vulnerable to Listeria because they are often not reheated prior to consumption, explained Andrew Zajac of the FDA's Office of Food Additive Safety. Cooking meat kills the Listeria bacterium, but foods can become contaminated after processing.
The FDA's approval of the mixture -- the first time viruses have been approved for use as a food additive -- is a "huge milestone" in the fight against food-borne illnesses, said John Vazzana, chief executive officer of Intralytix. Pregnant women, newborns and adults with weakened immune systems are especially vulnerable to listeriosis. The Centers for Disease Control and Prevention has estimated that 2,500 people become seriously ill with the infection each year, and 500 ultimately die from it.
Bacteriaphages are grown in a preparation of the same bacteria they are designed to kill, and then purified.
According to Intralytix, typical phages have hollow heads that store their viral DNA and tunnel tails with tips that bind to specific molecules on the surface of their target bacteria. The viral DNA is injected through the tail into the host cell, where it directs the production of progeny phages.
These "young" phages burst from the host cell, thereby destroying it, and go on to infect more bacteria. The viruses will not kill any organism other than their target bacteria.
Prior to issuing its approval, the FDA was concerned that the virus preparation might contain toxic residues associated with the bacteria. Tests found no residues present, however. In small quantities, such residues would be unlikely to cause any health problems, the FDA said. health.dailynewscentral.com
Refs: lntralytix, Inc. intralytix.com intralytix.com
"Before penicillin became the medical world's darling, crusading doctors crisscrossed the globe armed with bacteriophages, bacteria killing viruses that, when administered to diseased patients via injection or potion, could be powerful healers" U.S. News and World Report; Return of a killer -Phages may once again fight toughbacterial infections; November 2, 1998
CORE TECHNOLOGY
Simply stated, phages are viruses that infect bacteria. Like all viruses, phages are metabolically inert in their extracellular form and reproduce by insinuating themselves into the metabolism of the host bacteria. The viral DNA is then injected into the host cell, where it directs the production of progeny phages. These phages burst from the host cell, killing it and then infecting more bacteria (for more details see FAQ). There are innumerable types of phages, each capable of eradicating its host bacterial species. They are abundant in the biosphere and can be produced on a large scale, very economically. It is important to note that phages only attack bacteria and have absolutely no adverse effect on humans, animals or the environment.
Bacteriophages were discovered over 80 years ago, independently by both French and English scientists. It was quickly realized that phages had the potential to kill the bacteria that caused many infectious diseases in humans, as well as in agriculturally important plants and animals. An institute for the study and production of phages was founded in the mid 1930s in the Soviet Republic of Georgia and remains active today. Historically in the West, research into and application of phage therapy has been limited, with nominal commercialization. Its use all but ceased in the 1940s with the emergence of penicillin and other chemical antibiotics. However, over the last ten years there has been renewed interest in phage therapy, due largely to the growing resistance of many strains of bacteria to existing antibiotics.
Intralytix, Inc., is one of the pioneer companies in the United States working on the development and commercialization of therapeutic phages. Intralytix believes that bacteriophages can solve contamination problems in food processing, where it is seeking regulatory approval for its initial products, in hosptital and environmental sanitation, and in human therapeutics where the company has several candidate products ready for clinical trials. Intralytix addresses both common pathogens and antibiotic-resistant organisms in each of its product areas.
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