October 16, 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 Chris Owens, M.D., assistant professor of surgery in the 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 Tues., Oct. 23, from 8 to 10 a.m.
"Our lead product, PRT-201, represents a highly innovative approach to addressing the significant challenges associated with treating PAD. 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 in early 2013.
For more information: www.proteontherapeutics.com