Proteon Therapeutics, Inc. Initiates Phase 3 Clinical Study Of PRT-201 In Patients With Chronic Kidney Disease Undergoing Surgical Placement Of An Arteriovenous Fistula For Hemodialysis
7/21/2014 11:14:02 AM
WALTHAM, Mass.--(BUSINESS WIRE)--Proteon Therapeutics Inc., a privately held biopharmaceutical company developing novel, first-in-class pharmaceuticals to address the critical medical needs of patients with kidney and vascular diseases, announced today that the first patient has been treated in a pivotal Phase 3 clinical study of its lead product, PRT-201, in chronic kidney disease (CKD) patients undergoing surgical placement of an arteriovenous fistula (AVF). PRT-201, a locally-acting recombinant human elastase, is an investigational drug that may prolong the patency and reduce the failure of hemodialysis vascular access in patients with CKD. PRT-201 has received fast track and orphan drug designations from the U.S. Food and Drug Administration (FDA) and orphan medicinal product designation from the European Commission for hemodialysis vascular access indications.
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