Press Release

Proteon Therapeutics Initiates Patient Enrollment in Phase 1 Clinical Study of PRT-201 in Patients Suffering from Peripheral Artery Disease

October 15, 2012 at 1:16 PM EDT

Preclinical evidence supporting this Phase I research to be presented at TCT meeting

WALTHAM, MA., October 15, 2012 — Proteon Therapeutics, Inc., has initiated enrollment in a Phase 1 clinical study of its lead product, PRT-201, in patients with symptomatic peripheral artery disease (PAD) of the superficial femoral or popliteal artery. The open-label Phase 1 dose escalation study will enroll up to 16 patients being treated with balloon angioplasty. Immediately following angioplasty, PRT-201 will be delivered to the arterial wall using the Mercator MedSystems Bullfrog® Micro-Infusion Catheter. The primary endpoint of the study will be safety, and efficacy endpoints will be evaluated as well.

“Current treatments of PAD, such as balloon angioplasty and stenting, are associated with unacceptably high rates of restenosis. Treatment with PRT-201 following balloon angioplasty is a novel approach that may prolong patency while avoiding the need for stent implantation,” said Dr. Chris Owens, Assistant Professor of Surgery Division of Vascular and Endovascular Surgery at the University of California San Francisco, who is the principal investigator for the study.

The clinical trial follows successful preclinical studies demonstrating the potential of PRT-201 to enhance revascularization outcomes in patients suffering from PAD. Proteon will be presenting two posters at the 24th Annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium, sponsored by the Cardiovascular Research Foundation. Abstracts TCT-159 and TCT-160, which provide results from ex vivo studies of PRT-201 treatment of human atherosclerotic arteries, will be presented Tuesday, Oct. 23, 2012, from 8 to 10 a.m.

“Our lead product, PRT-201, represents a highly innovative approach to addressing the significant challenges associated with treating peripheral vascular disease. We believe that local catheter delivery of PRT-201, immediately following balloon angioplasty, could potentially reduce the incidence of restenosis in PAD, resulting in improved outcomes and fewer interventions,” said Timothy P. Noyes, President and CEO of Proteon.

This is the fourth clinical study evaluating PRT-201’s ability to improve vascular outcomes. Proteon previously completed enrollment in three clinical studies evaluating topical delivery of PRT-201 immediately following surgical creation of an arteriovenous fistula (AVF) or arteriovenous graft (AVG) in patients with chronic kidney disease preparing for or on hemodialysis. Data from Proteon’s 150-patient Phase 2 AVF study and 89-patient Phase 1/2 AVG study are expected early in 2013.

About Peripheral Arterial Disease

Peripheral artery disease, or PAD, is characterized by fatty plaque build-up in the arteries of the legs, which leads to poor blood flow. According to the American Heart Association, PAD affects eight million Americans and is a significant cause of both morbidity and mortality. Patients with PAD may experience muscle pain during walking, suffer from ulcers that are slow to heal or, in the most severe cases, require amputation. Current interventional procedures, such as balloon angioplasty, are inadequate because of high rates of restenosis.

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 the impact of stenosis and prolong vessel patency. Improved patency may lead to fewer surgical and interventional 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


Timothy Noyes

President and CEO



Steve Walker