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11-15-95
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11-15-95
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AN <br /> Product Portfolio <br /> GalaGen's lead products in development target serious human gastrointestinal diseases. Natural beneficiaries <br /> of several of these products include AIDS and oncology patients with compromised immune systems. <br /> • SPORIDIN-GTE' AIDS diarrhea, caused by Cryptosporidium parvum <br /> • CANDISTAT-GTM Yeast infections of the mouth and esophagus caused by Candida albicans(thrush) <br /> • HELISTAT-G Ulcers and gastritis caused by Helicobacter pylori <br /> GalaGen has a full product pipeline. Products at earlier stages in development are directed at <br /> antibiotic-associated diarrhea caused by Clostridium drfficile, and traveler's diarrhea caused by Shigella <br /> flexneri and enterotoxic E. coli. <br /> In addition to these products, GalaGen can generate new products in an accelerated way with a minimum of <br /> early stage preclinical research and at relatively low cost. Once a pathogen target has been identified and <br /> immunizing materials obtained, GalaGen can produce clinical trial quantities of the antibody product in less <br /> than six months. <br /> Safety <br /> The safety of GalaGen's products is unique for drugs in development. The burden of proof for any new <br /> pharmaceutical is safety and efficacy. Many new products drop out of development due to safety concerns, <br /> even though they hold high promise for efficacy. GalaGen's products consist of common milk proteins and <br /> their safety profile should be similar to milk itself. They should be appropriate for administration to all age <br /> groups, with the exception of those individuals who cannot tolerate drinking dairy products due to an allergy <br /> or severe lactose intolerance. The Company has demonstrated that no measurable antibody reaches the <br /> systemic circulation. The probability of bringing one of GalaGen's bovine antibody products to market <br /> should be increased substantially by these safety features, especially when compared to a new chemical entity <br /> or biopharmaceutical. <br /> Activity <br /> Bovine antibodies represent a new class of oral therapeutics. While antibodies have been used for decades to <br /> prevent or treat human infections —such as gamma globulin shots for hepatitis—antibodies have not been <br /> typically administered orally to treat gastrointestinal infections. Bovine antibodies are uniquely structured to <br /> resist digestion in the upper gastrointestinal tract and bind with and kill or inhibit pathogens throughout the <br /> gastrointestinal system. In addition to their safety, bovine antibodies are: <br /> • active against all major classes of human pathogens: bacteria, viruses, fungi and parasites. <br /> • target individual pathogens without destroying beneficial bacteria. <br /> • polyclonal, meaning that they target many individual features of a pathogen and therefore diminish <br /> the likelihood that a pathogen will develop resistance to the product. <br />
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