PRT-201 is an investigational recombinant human elastase that is being studied for its ability to improve arteriovenous fistula (AVF) and arteriovenous graft (AVG) outcomes in patients requiring chronic hemodialysis.
In preclinical trials PRT-201 has showed reduction in neointimal hyperplasia formation, and to cause dilation of segments of arteries and veins following topical intraoperative application.
The current study follows successful completion of a 66-patient, double-blind, placebo-controlled Phase 1/2 study of PRT-201 in AVF patients that completed enrollment in July 2010.
Proteon president and CEO Timothy Noyes said PRT-201 represents an innovative approach to addressing the significant medical challenges associated with vascular access in CKD patients.