MEDIWOUND LAUNCHES DEBRASE GEL DRESSING PHASE IIB TRIAL.MediWound Ltd., an Israeli company developing and commercializing Debrase Gel Dressing has commenced a multi- center controlled phase IIb clinical trial, in patients with deep partial thickness or full thickness thermal burns, in Europe and the US. Debrase is an innovative debriding agent that swiftly and selectively removes the eschar eschar /es·char/ (es´kahr) 1. a slough produced by a thermal burn, by a corrosive application, or by gangrene. 2. tache noire. es·char n. tissue from burn wounds by means of enzymatic action. The objectives of this study are to evaluate the safety and enzymatic debriding efficacy of Debrase Gel Dressing in hospitalized patients and to compare Debrase Gel Dressing to Standard-of-Care treatment. In addition, possible deleterious effects of the vehicle on wound healing wound healing Physiology The repair of a wound Steps Inflammation, repair and closure, remodeling, final healing; repair of incisions may be either simple–'clean' wounds with little loss of tissue heal by 'primary intention', or 'dirty' wounds heal by will be examined. The trial is being conducted by Inveresk Research International (IRI Iri (ē`rē`), former city, North Jeolla (Cholla) prov., SW South Korea. An agricultural center and transportation hub, it was absorbed into Iksan. ), and is expected to conclude by the end of 2003. Debrase Gel Dressing(TM) has been granted orphan drug orphan drug, drug developed under the U.S. Orphan Drug Act (1983) to treat a disease that affects fewer than 200,000 people in the United States. The orphan drug law offers tax breaks and a seven-year monopoly on drug sales to induce companies to undertake the designation in the E.C., thus assuring exclusivity for the product for a period of 10 years from the date of marketing approval of the product. Manufacturing of clinical material is well under way in the company's GMP GMP (guanosine monophosphate): see guanine. plant in Yavne. Prof. Marian Gorecki, MediWound's 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. , expressed his satisfaction on this advanced clinical milestone: "Debrase is an important product that targets an unmet clinical need. This clinical trial will serve as further validation to the already existing clinical data collected from approximately 300 burn victims. MediWound is an attractive growth and investment opportunity, to be closely monitored by potential big-pharma partners." MediWound Ltd. is a portfolio company of Clal Biotechnology Industries Ltd., Israel's leading investor in life sciences. For more information, visit http://www.mediwound.co.il or http://www.cbi.co.il. |
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