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May 21, 2014
07:05 EDTMDWDMediWound initiates second Phase 2 clinical trial of EscharEx
MediWound announces initiation of its second Phase 2 clinical trial of EscharEx to treat chronic and other hard-to-heal wounds. EscharEx is based on MediWound's patented proteolytic enzyme technology. This prospective, randomized, controlled, multicenter Phase 2 study of approximately 72 subjects is planned to be conducted at approximately 10 clinical sites and intends to evaluate safety and efficacy of EscharEx compared with gel vehicle for the treatment of a variety of chronic and other hard-to-heal wounds, including diabetic foot ulcers, or DFUs, venous ulcers and post-surgical or traumatic hard-to-heal wounds. The blinded study intends to assess non-viable tissue removal, wound bed preparation and wound healing as well as other additional endpoints. The Company has concluded a Phase 2 feasibility study of EscharEx to treat chronic and other hard-to-heal wounds in 24 patients at two clinical sites in Israel. The results from that trial demonstrated efficacy in debriding various wound etiologies such as DFUs, venous ulcers, pressure sores and other post-surgical or post-trauma hard-to-heal wounds.
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