Foodborne illness of microbial origin continues to be a serious food safety problem worldwide. The Center for Disease Control and Prevention (CDC) has estimated ¹ that foodborne pathogens cause approximately 76 million illnesses and 5,000 deaths each year in the United States alone. At the present time, the leading causes of death due to foodborne bacterial pathogens are Listeria and Salmonella, followed closely by other food borne pathogens such as Escherichia coli (E. coli O157:H7, in particular) and Campylobacter jejunii. Bacteriophages may provide a natural, non-toxic, safe, and effective means for significantly reducing or eliminating contamination of foods with specific pathogenic bacteria, thereby eliminating the risk, or significantly reducing the magnitude and severity, of foodborne illness caused by the consumption of foods contaminated with those bacteria. Intralytix has developed and is continuing to develop bacteriophage-based products targeting some of the deadliest foodborne bacterial pathogens, including L. monocytogenes and E. coli O157:H7.

Listeria monocytogenes and LMP-102™

Disease caused by L. monocytogenes (listeriosis) has one of the highest fatality rates (approximately 20%) among all foodborne bacterial diseases and, therefore, is of particular concern for human safety. Several outbreaks of foodborne listeriosis have been reported since 1980, when the bacterium was first associated with food borne transmission. A variety of contaminated foods, including coleslaw, unpasteurized cheese, pasteurized milk, delicatessen meat, and other ready-to-eat (RTE) meat products have been reported to be sources of the etiologic agent. The high fatality rate associated with listeriosis caused the United States Food and Drug Administration (FDA) and the Food Safety Inspection Service of the United States Department of Agriculture to establish a “zero tolerance” for L. monocytogenes in RTE foods. However, eliminating L. monocytogenes from food processing plants has proved to be a very difficult task, and foods contaminated with L. monocytogenes have continued to be important public health problems which have resulted in numerous food recalls.

Intralytix has developed a bacteriophage-based preparation, designated LMP-102™, to reduce or eliminate the risk of foodborne listeriosis. The preparation consists of six naturally-occurring bacteriophages isolated from the environment and exhaustively studied and carefully selected for inclusion in LMP-102™ by Intralytix’s scientists. The preparation, when sprayed onto RTE foods, significantly reduces (usually by 100-1000-fild) contamination of those foods with L. monocytogenes. LMP-102™ is an all-natural product, and media/components of animal origin are not used during its preparation. Also, it does not contain preservatives or known, potentially-allergenic substances (wheat, milk, soy, etc.), and it does not alter the general composition, taste, odor or color of foods.
On 18 August 2006, the FDA approved LMP-102™ as an additive for RTE foods. At the present time, Intralytix is the only company in the world to have received FDA approval for using a bacteriophage-based preparation as a food additive. Intralytix considers LMP-102™ to be one of the safest and most environmentally-friendly natural products for significantly reducing the risk of foodborne human listeriosis due to the consumption of contaminated RTE foods.

Escherichia coli O157H:7 and ECP-100™

E. coli O157:H7 is a significant contributor to foodborne illnesses worldwide. It has been estimated ¹ to cause approximately 62,000 cases of foodborne disease/year (and ca. 1,800 foodborne illness-related hospitalizations/year) in the United States alone, at an annual cost of ca. 0.7 billion dollars ². Most recently, the importance of E. coli O157H:7 as an important food safety concern was emphasized in the summer and autumn of 2006. During that time, it caused a multi-state outbreak associated with contaminated spinach, which resulted in 199 clinical cases and 3 deaths in 26 states.

Intralytix has developed a new phage-based product, designated ECP-100™, which is effective against E. coli O157H:7. Similar to LMP-102™, ECP-100™ is 100% natural, and it does not contain preservatives or any known, potentially-allergenic substances. The product is in the final stages of efficacy testing, and Intralytix expects that it will be highly effective in reducing contamination of various foods (e.g., ground beef, fruits, vegetables, etc.) with E. coli O157:H7, thus providing a much needed modality for significantly reducing or eliminating contamination of various food products with the bacterium.

Other bacteriophage preparations that can be used to improve food safety are currently in the early development stage or are being considered for development. In general, Intralytix views its bacteriophage technology as an invaluable tool for improving the safety of foods by utilizing it in various settings in the food production and processing chain, including:

• Poultry production and processing
• Meat production and processing
• Seafood production and processing
• Fruits & vegetables production and processing
• Production and processing of other foods
  
  

References:

1. Mead, P. S., Slutsker, L., Dietz, V., McCaig, L. F., Bresee, J. S., Shapiro, C., Griffin, P. M., and Tauxe, R. V., Food-related illness and death in the United States, Emerg Infect Dis 5 (5), 607-25, 1999.
2. Buzby, J. C., Children and microbial foodborne illness, Food Review 24, 32-37, 2001.