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news.Proteon Therapeutics, a company developing novel, first-in-class therapeutics to address the medical needs of patients with kidney and vascular diseases, announced top-line results from its Phase 1 study of investigational vonapanitase in patients with symptomatic peripheral artery disease (PAD).
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This study evaluated the safety and technical feasibility of a single treatment of vonapanitase via a drug-delivery catheter on atherosclerotic human arteries. The data indicate that catheter-based treatment with vonapanitase was generally well tolerated and technically feasible.
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. Christopher D. Owens, M.D., Associate Professor of Surgery Division of Vascular and Endovascular Surgery at the University of California San Francisco, was the principal investigator for the study.
"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 symptomatic PAD results."
Proteon continues to conduct a full analysis of safety and technical feasibility data from the study. Proteon expects that complete data from this Phase 1 study will be presented at an upcoming medical meeting.
"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 P. Noyes, President and CEO of Proteon. "Based on these results, we plan to further study whether the local delivery of vonapanitase could potentially provide a clinical benefit to patients with PAD, and we are currently evaluating our potential next steps in this clinical area."
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.