MediWound, 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 a debriding agent that swiftly and selectively removes the eschar 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 will be examined.
The trial is being conducted by Inveresk Research International (IRI), and is expected to conclude by the end of 2003.
Debrase Gel Dressing has been granted orphan drug designation in the EC, 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 plant in Yavne. — (menareport.com)
© 2003 Mena Report (www.menareport.com)
