Proteon Therapeutics Announces Positive Phase 2 Trial Results of PRT-201 in Chronic Kidney Disease Patients Undergoing Surgical Placement of an Arteriovenous Fistula for Hemodialysis

WALTHAM, Mass., Jan. 4, 2013 /PRNewswire/ -- Proteon Therapeutics, Inc., a private biopharmaceutical company developing novel, first-in-class pharmaceuticals to address the critical medical needs of patients with kidney and vascular diseases, today announced results from its Phase 2 clinical trial of PRT-201 in chronic kidney disease (CKD) patients undergoing surgical placement of an arteriovenous fistula (AVF) in preparation for hemodialysis. The Phase 2 results demonstrated that treatment with PRT-201 prolonged primary unassisted patency and improved the rate of AVF maturation. Additionally, PRT-201 was well tolerated at the doses tested.

The arteriovenous fistula is the optimal form of vascular access for hemodialysis patients because it is associated with reduced morbidity and lower costs. However, AVFs frequently suffer from neointimal hyperplasia and stenosis formation, resulting in maturation failure and loss of patency.

"AVF patency loss and non-maturation are significant problems, necessitating multiple endovascular (angioplasty) and surgical procedures to restore or maintain blood flow and resulting in prolonged use of dialysis catheters, which have a very high rate of infection. This results in poorer outcomes and significantly increases morbidity and cost," said Dr. Prabir Roy-Chaudhury, Professor of Medicine at the University of Cincinnati, Academic Health Center, Cincinnati, OH. "In this context, the safety and efficacy results of this Phase 2 study are very encouraging and warrant further evaluation of PRT-201 in this patient population."

The randomized, double-blind, placebo-controlled Phase 2 study evaluated the safety and efficacy of PRT-201 delivery immediately following surgical creation of an AVF. A total of 151 patients were randomized to one of two doses of PRT-201, or placebo. The primary endpoint was the duration of unassisted primary patency, defined as the time from surgical creation of the AVF until thrombosis or the occurrence of a procedure to maintain or restore patency (e.g., balloon angioplasty). AVF maturation was a secondary efficacy endpoint.

"Our lead product, PRT-201, represents a highly innovative approach to addressing the significant challenges associated with vascular access in patients with CKD, and we are very excited about the potential for PRT-201 to dramatically improve care for dialysis patients," said Timothy P. Noyes, President and CEO of Proteon. "Based on the positive results from this Phase 2 study, Proteon intends to advance PRT-201 into Phase 3 studies."

Proteon is conducting a robust clinical research program evaluating PRT-201's ability to improve vascular outcomes. Proteon previously completed a Phase 1/2 AVF study, the results of which were recently published in the Journal of Vascular Access, and recently completed follow-up in a Phase 1/2 study in patients undergoing surgical placement of an arteriovenous graft (AVG). The AVG study results are expected in the first half of 2013. In October 2012, Proteon initiated enrollment in a Phase 1 study in which PRT-201 is delivered via a catheter following angioplasty of the superficial femoral or popliteal artery in patients with symptomatic peripheral artery disease.

About PRT-201
PRT-201 is an investigational recombinant human elastase that is being studied for its ability to improve outcomes in patients suffering from vascular disease. Elastase has been shown in certain preclinical settings to reduce neointimal hyperplasia formation and to cause dilation of segments of arteries and veins. These effects may decrease stenosis and prolong vessel patency. Improved patency may lead to fewer corrective surgical procedures, fewer hospitalizations, lower costs and less suffering for patients. PRT-201 has received fast track and orphan drug designations from the FDA for the indication of improving AVF and AVG surgical outcomes.

About Proteon Therapeutics
Proteon Therapeutics, Inc. is a privately held biopharmaceutical company developing novel, first-in-class pharmaceuticals to address the critical medical needs of patients with kidney and vascular diseases. The company is headquartered in Waltham, MA., and has research facilities in Kansas City, MO. For additional information, please visit www.proteontherapeutics.com.

SOURCE Proteon Therapeutics, Inc.