Proteon Therapeutics Announces Results from Phase 1 Study of Investigational Drug Vonapanitase in Patients with Symptomatic Peripheral Artery Disease Presented at TCT 2015

Proteon Therapeutics Inc. PRTO, a company developing novel, first-in-class therapeutics to address the medical needs of patients with kidney and vascular diseases, today announced that results from its Phase 1 study of investigational vonapanitase in patients with symptomatic peripheral artery disease (PAD) were presented at the 27th Transcatheter Cardiovascular Therapeutics (TCT), the annual scientific symposium of the Cardiovascular Research Foundation. The results were presented by Christopher D. Owens, M.D., Associate Professor of Surgery Division of Vascular and Endovascular Surgery at the University of California San Francisco, who was the principal investigator of the study. This study evaluated the safety and technical feasibility of a single treatment of vonapanitase via a drug-delivery catheter to atherosclerotic human arteries following successful angioplasty. The study met its stated objectives, as data indicated that catheter-based treatment with vonapanitase was generally well-tolerated and technically feasible. "There is a significant unmet medical need to improve results in patients with symptomatic PAD," said Dr. Owens. "The safety and technical feasibility results of this Phase 1 study are encouraging, and merit further study of vonapanitase in patients with PAD, to explore whether vonapanitase will demonstrate efficacy in the improvement of PAD." The open-label, single center Phase 1 dose escalation study enrolled 14 patients being treated with balloon angioplasty due to symptomatic PAD of the superficial femoral or popliteal artery. Immediately following successful angioplasty, vonapanitase was delivered to the arterial wall using an endovascular micro-infusion catheter. "This Phase 1 study in patients with symptomatic PAD complements Proteon's ongoing clinical development in patients with chronic kidney disease undergoing surgical creation of an arteriovenous fistula for hemodialysis," said Timothy Noyes, President and Chief Executive Officer of Proteon. "Based on these results, we plan to continue clinical investigation of vonapanitase in PAD in 2016." This is the sixth clinical study evaluating vonapanitase. Proteon is currently evaluating vonapanitase in two Phase 3 clinical studies in patients with chronic kidney disease (CKD) undergoing surgical creation of a radiocephalic arteriovenous fistula (AVF) for hemodialysis, and previously completed three clinical studies evaluating vonapanitase in patients with CKD undergoing surgical creation of an AVF or arteriovenous graft (AVG) for hemodialysis.