PURE Bioscience's Axen30 May Be Key to Listeria Control

SAN DIEGO -- The patented silver dihydrogen citrate disinfection technology from PURE Bioscience could be a powerful new weapon against the dangerous Listeria monocytogenes bacterium.

The Centers for Disease Control and Prevention (CDC) lists Listeriosis as a serious infection caused by eating food contaminated with the bacterium Listeria monocytogenes. Listeriosis has recently been recognized as an important public health problem in the United States where an estimated 2,500 people become seriously ill with listeriosis each year and 500 die. In recent years, ready-to-eat meat and poultry products have been responsible for the majority of Listeriosis infections.

An outbreak of Listeria in 2002 traced to contaminated turkey meat resulted in 54 illnesses, eight deaths and three fetal deaths in nine states. In addition to significant consumer health risk, Listeria causes great economic cost to companies that must implement recalls of enormous quantities of meats following identification of Listeria in processing facilities. In 1991, an Arizona company with processing facilities in Oklahoma recalled more than 14 million pounds of internationally distributed meat products because of Listeria contamination. Not all recalls are so extensive, but, unfortunately, they have become regular news headlines. Just last week, a Utah meat processing company issued a voluntary recall of 5,400 pounds of hot dogs that may have been contaminated with Listeria. The USDA categorized the recent recall as a Class I Recall indicating a high health risk.

Listeria is killed by pasteurization and cooking; however, in certain ready-to-eat foods such as hot dogs and deli meats, contamination may occur after cooking but before packaging. The CDC's recommendation includes improving the safety of processed meats through meticulous in-plant sanitation.

The CDC points out that the Food and Drug Administration (FDA) and the U.S. Department of Agriculture (USDA), along with the food industry, are working to reduce contamination of food by the Listeria bacterium. For example, the USDA Food Safety and Inspection Services (FSIS) recently strengthened regulations to reduce Listeria in ready-to-eat meat and poultry products by requiring all establishments to develop written programs such as Sanitation Standard Operating Procedures to control Listeria and to verify the effectiveness of those programs. The rule also encourages all establishments to employ additional and more effective Listeria control measures. The new rule becomes effective in December 2004.

The USDA FSIS has published compliance guidelines for controlling Listeria in ready-to-eat meat and poultry products. Many of the guidelines focus on environmental sanitation methods of controlling Listeria and reference traditional hazardous chemicals including acidic quaternary ammonia, peracetic acid and chlorine dioxide as the most effective sanitizers against Listeria.

The USDA FSIS has also posted guidance documents regarding prevention and control of Listeria, including the September 2001 publication from Dr. William R. Henning and Dr. Catherine Cutter from the Pennsylvania State University, "Controlling Listeria Monocytogenes in Small and Very Small Meat and Poultry Plants." As mentioned in the Penn State paper, food processing operations must make every effort to prevent Listeria contamination of meat products at all levels of production. The Penn State paper specifically highlights the importance of environmental hard surface sanitization in the prevention and control of Listeria. Recommendations include periodic sanitizing of all processing equipment, floors, drains, waste containers, storage areas, walls, coolers and pallets.

Like the USDA FSIS compliance guidelines, the Penn State paper identifies traditional poisonous chemicals as effective sanitizers against Listeria, including quaternary ammonia compounds, chlorine solutions and products containing peracetic acid.

PURE Bioscience's silver dihydrogen citrate-based Axen30 hard surface disinfectant is designed to set a new standard in preventing and controlling environmental Listeria contamination.

Michael L. Krall, president and CEO of PURE Bioscience, stated, "A preliminary study conducted by the USDA to determine the efficacy of our silver dihydrogen citrate-based formulations in poultry processing applications concluded that our technology could have commercial applications for sanitation practices and Listeria control in the poultry processing environment. The study also included corrosion experiments which showed no detectable corrosion of stainless steel after exposure to our silver dihydrogen citrate formulation."

Subsequent independent testing of PURE's EPA-approved Axen30 hard surface disinfectant confirms the efficacy found in the USDA study and specifies a remarkable 30 second disinfection kill time for Listeria -- 20 times faster than the 10-minute disinfection kill time claims by the hazardous chemical products currently used for Listeria control.

Based on the EPA toxicity categorization of antimicrobial products ranging from Category I (high toxicity) down to Category IV, Axen30 is a Category IV antimicrobial for which precautionary labeling statements are normally not required. This compares with Category I and II warning statements for most current Listeria control products.

Krall continued, "As we continue to aggressively market our silver dihydrogen citrate technology to industry segment leaders, including food processing companies, our strongest strategy is always to compare the extraordinary efficacy and reduced toxicity of silver dihydrogen citrate technology with traditional toxic chemicals."

PURE Bioscience's antimicrobial technologies lead today's global trend toward industry and consumer use of "green" products while providing competitive advantages in efficacy and safety. This new molecule, silver dihydrogen citrate (SDC), is an electrolytically generated source of stabilized ionic silver that can serve as the basis for a broad range of products in diverse markets. SDC liquid is colorless, odorless, tasteless, non-caustic and formulates well with other compounds.

PURE currently has Environmental Protection Agency (EPA) registration for its 2400-parts per million (ppm) technical grade SDC concentrate as well as for its Axen and Axen 30 hard surface disinfectant products for commercial, industrial and consumer applications including restaurants, homes and medical facilities. The company plans to register several new products with the EPA this year. In addition to EPA-approved uses of SDC technology, PURE, in conjunction with Therapeutics, Incorporated, is pursuing the development and commercialization of FDA-regulated SDC-based healthcare products. Initial investigations show that silver dihydrogen citrate's broad spectrum of effectiveness combined with its low toxicity and low potential to induce bacterial resistance may provide important therapeutic advances in the treatment of a number of medical diseases and conditions. Therapeutics, Incorporated has identified several potential Axenohl based women's health products as well as potential acne treatment products as the first groups of FDA-regulated products using PURE's SDC antimicrobial technology for which it intends to pursue FDA approvals. Therapeutics expects its development efforts will lead to the filing of Investigational New Drug (IND) with the FDA.

Source: PURE Bioscience