|Protalex, Inc., is a Delaware Corporation. It is a development stage company which is engaged in developing a class of biopharmaceutical drugs for treating autoimmune and inflammatory diseases. The Company’s product, PRTX-100, has demonstrated effectiveness in pre-clinical studies in regulating the immune system with persisting effects. The effectiveness of PRTX-100 shown in pre-clinical studies using animal models might not be predictive of the results that it would see in future clinical trials. PRTX-100 has the ability, at very low concentrations, to bind to and to down regulate activation of human B-lymphocytes and macrophages which are key cells mediating inflammation in certain autoimmune diseases. Laboratory studies indicate the mechanism involves interference with specific intracellular signaling pathways. Pre-clinical studies also demonstrate that very low doses of PRTX-100 have potent therapeutic effects on model inflammatory diseases. The Company believes, based on the pre-clinical trials and the result of the two Phase I clinical trials, that its compound, PRTX-100, has a potential competitive advantage, as it might require lower doses and has the potential to be more convenient, safer and more efficacious than existing therapies. The FDA and comparable regulatory agencies in state and local jurisdictions and in foreign countries impose substantial requirements upon the testing (preclinical and clinical), manufacturing, labeling, storage, recordkeeping, advertising, promotion, import, export, marketing and distribution, among other things, of drugs and drug product candidates.|
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