PROTEO, INC. / PROTEO Biotech AG Commissions the Manufacture of Elafin to GMP-Standards in Belgium; Elafin for Clinical Testing.KIEL, Germany -- Elafin, the anti-inflammatory protein of PROTEO Biotech AG, will be subjected to clinical testing in the very near future, representing a further step on its way to being licensed as a drug. The authorities demand strict standards for the manufacture of medicines for clinical testing, and the GMP GMP (guanosine monophosphate): see guanine. (Good Manufacturing Practice Good Manufacturing Practice or GMP (also referred to as 'cGMP' or 'current Good Manufacturing Practice') is a term that is recognized worldwide for the control and management of manufacturing and quality control testing of foods and pharmaceutical products. ) production of Elafin for the upcoming trials has to comply with a large number of rules and regulations. "That's why we have chosen Eurogentec S.A. in Belgium to produce the required amounts of Elafin for us," commented Walter J. Thomsen, CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. of PROTEO Biotech AG. Thomsen added that the manufacture of Elafin to GMP standards is too complex for a company like PROTEO. By contrast, Eurogentec, situated in Liege liege In European feudal society, an unconditional bond between a man and his overlord. Thus, if a tenant held estates from various overlords, his obligations to his liege lord, to whom he had paid “liege homage,” were greater than his obligations to the other , Belgium has 290 employees as well as the necessary infrastructure and experience to produce biologically and pharmaceutically active substances quickly and in sufficient amounts for the approaching clinical trials. The collaboration of the two companies was sealed on the 23rd of March 2005. The production of Elafin is due to begin on the 11th of April and will be completed in the first week of July. "We are aiming to get Elafin licensed as a drug in as short a time as possible and cooperating with Eurogentec will ensure that we achieve our goal." Thomsen explains. Proteo's Elafin is of human origin and is one of the most potent inhibitors of human elastase elastase /elas·tase/ (e-las´tas) see pancreatic elastase. e·las·tase n. An enzyme found especially in pancreatic juice that catalyzes the hydrolysis of elastin. and proteinase proteinase /pro·tein·ase/ (pro´ten-as?) endopeptidase. pro·tein·ase n. A protease that begins the hydrolytic breakdown of proteins usually by splitting them into polypeptide chains. 3, and therefore a compound with high biological activity and with less unforeseeable Un`fore`see´a`ble a. 1. Incapable of being foreseen. Adj. 1. unforeseeable - incapable of being anticipated; "unforeseeable consequences" unpredictable - not capable of being foretold side effects and insignificant allergenic potential compared to most synthetic alternatives. The results of pre-clinical trials, shows great promise in the treatment of tissue and muscle damage. Elafin reduces damage to heart muscles caused by blood supply deficiencies. This indicates its applicability in the treatment of cardiac infarction. Proteo, founded in 2000 specializes in the biological and medical research and development of human derived agents with the focus on drug development against inflammation. Proteo has established its own pilot plant and expertise in scale-up of recombinant protein production. |
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