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Nisin – Skin and Environment Sanitizing Products. In addition to animal health applications of Nisin, ImmuCell has acquired rights and developed intellectual property related to human skin and environmental applications of Nisin (non-prescription). For example ImmuCell, in collaboration with U.S. Army Edgewood Chemical and Biological Center, has shown that Nisin formulations kill vegetative cells and germinating spores of Anthrax (Future Directions for Biodefense Research: Development of Countermeasures. American Society of Microbiology, 2003, p27). Wipe Out Dairy Wipes, presently marketed to clean and sanitize the udder prior to milking, have both potent antibacterial action and skin conditioning agents, making them ideal as a skin sanitizing wipe. ImmuCell intends to continue pursuing skin health applications of its Nisin technology, including uses for consumers, military personnel, and workplace areas; anywhere pre-moistened antibacterial wipes, gentle to the skin, can be used. ImmuCell’s Milk Immunoglobulin Technology During the 1990s, ImmuCell conducted several human clinical trials of its milk immunoglobulins to combat gastrointestinal infections. This work received approximately $2MM in funding from the National Institutes of Health, and resulted in several peer reviewed publications. Presently two such products have demonstrated preliminary efficacy in human trials, and are in various stages of further development; DiffGAM™ and TravelGAM™. TravelGAM™ anti-E.coli milk antibodies are being further studied in collaboration with the Naval Medical Research Center under funding from the Department of Defense Peer Reviewed Medical Research Program to determine optimal E. coli strains and formulations to enable its use in combating Travelers Diarrhea. DiffGAM™ anti-Clostridium difficile milk antibodies are an attractive alternative to traditional drugs to aid in the control or prevention of Clostridium difficile associated colitis (CDAD), a debilitating gastrointestinal disease that can be precipitated by the use of broad spectrum antibiotics. Both TravelGAM™ and DiffGAM™ are sourced from the milk of donor cows from commercial dairy herds under contract to ImmuCell. Like First Defense®, antibodies specific to the pathogen(s) of interest, are developed through immunization of the donor cows, and purified from their milk. These antibodies are dried and formulated for oral administration. Companies interested in licensing, marketing or partnering with ImmuCell for any of these products for human health applications should contact info@immucell.com. Crypto-Scan® – Diagnostic test for drinking water supplies Waterborne Cryptosporidium parvum has become a major threat to water supplies worldwide. There have been increasing numbers of outbreaks of waterborne cryptosporidiosis in the last 15 years, despite significant efforts to detect and control this parasite. Crypto-Scan® was developed to improve the detection of C. parvum in drinking water supplies used by many municipal water companies. After a water sample is collected and concentrated, the Crypto-Scan® immunomagnetic separation technology prepares the sample for microscopic detection of the Cryptosporidium parasite. The United Kingdom represents the company’s primary market target for this product due to the in-country regulatory conditions. In late 2000, ImmuCell received approval as an official product under the recently enacted Water Supply Regulations by the Drinking Water Inspectorate ("DWI") in the United Kingdom. The DWI has mandated continuous monitoring of over 300 water sources in England and Wales under new regulations that became effective in 2000.
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