Proteon Therapeutics Announces Overview of Phase I Clinical Program

Proteon Therapeutics, Inc. recently announced that an overview of the company’s Phase I clinical program of investigational vonapanitase in peripheral artery disease (PAD) was presented at the 28th Transcatheter Cardiovascular Therapeutics (TCT) conference, the annual scientific symposium of the Cardiovascular Research Foundation, in Washington, DC.

The presentation, titled Arterial Dilatation with Recombinant Human Elastase: A Novel Approach to Treating Peripheral Vascular Disease, was given by Dr. Ehrin J. Armstrong, Associate Professor, Medicine-Cardiology at University of Colorado School of Medicine and Director, Interventional Cardiology VA Eastern Colorado Healthcare System.

“Current treatments for patients with PAD have poor long-term durability in alleviating clinical symptoms,” said Dr. Armstrong. “Proteon’s innovative approach with vonapanitase has the potential to provide an important new option for patients suffering from PAD.”

Dr. Armstrong discussed the company’s two planned Phase I clinical studies evaluating vonapanitase, a recombinant human elastase. These multicenter, dose-escalation studies will evaluate the safety and technical feasibility of a single administration of vonapanitase as a monotherapy and as an adjunct to angioplasty for patients with PAD. The company expects to initiate both studies in 2016.

Patients with peripheral artery disease (PAD) of the lower extremities experience stenosis, or blockage, in the arteries providing blood to the legs. These patients typically present with exercise-induced leg pain, a condition known as intermittent claudication. Symptoms of claudication include impaired walking function as patients quickly experience leg pain that can be resolved only through rest. In advanced cases of PAD, known as critical limb ischemia, a severe lack of blood flow causes leg pain at rest, which can result in gangrene or tissue death and the need for amputation. Current revascularization procedures to address PAD are often ineffective and lack durability, resulting in ongoing suffering for patients. PAD is a global problem affecting a large and growing number of people in developed and developing countries. An estimated eight to 12 million Americans are affected by PAD.

Vonapanitase (formerly PRT-201) is an investigational drug designed to treat vessel injury response that leads to blockages in blood vessels and reduced blood flow. Vonapanitase is applied in a single administration and is currently being studied in two Phase III clinical trials, PATENCY-1 and PATENCY-2, in patients with chronic kidney disease (CKD) undergoing surgical creation of a radiocephalic arteriovenous fistula (AVF) for hemodialysis. Proteon previously completed a Phase I clinical trial with vonapanitase in patients with PAD. Vonapanitase has received fast track and orphan drug designations from the US FDA, and orphan medicinal product designation from the European Commission, for hemodialysis vascular access indications.

Proteon Therapeutics is committed to improving the health of patients with kidney and vascular diseases through the development of novel, first-in-class therapeutics. Proteon’s lead product candidate, vonapanitase, is an investigational drug intended to improve arteriovenous fistula (AVF) patency, the period of time during which an AVF remains open with adequate blood flow to enable hemodialysis. Proteon is currently evaluating vonapanitase in two Phase III clinical trials, PATENCY-1 and PATENCY-2, in patients with chronic kidney disease (CKD) undergoing surgical creation of a radiocephalic AVF for hemodialysis. In addition, Proteon has completed a Phase I clinical trial in patients with PAD. For more information, visit www.proteontherapeutics.com.