|Proteon Therapeutics Announces Results from Phase 1 Study of Investigational Drug Vonapanitase in Patients with Symptomatic Peripheral Artery Disease Presented at TCT 2015|
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
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.
About Peripheral Artery Disease (PAD)
Patients with peripheral artery disease (PAD) of the lower extremity experience stenosis, or blockage, formation in the arteries providing blood to the legs. These patients typically present with exercise-induced leg pain, a condition known as intermittent claudication. Patients with claudication are unable to adequately maintain their activities of daily living because they quickly experience pain that can be resolved only through rest. Severe cases result in critical limb ischemia, or lack of blood flow, and the possibility of gangrene or tissue death and the need for amputation. Current surgical and interventional procedures are often ineffective and lack durability, resulting in ongoing suffering for patients. PAD is a global problem affecting a large number of people throughout the industrialized world. Approximately eight million Americans have some form of PAD.
Vonapanitase (formerly PRT-201) is an investigational drug designed to improve arteriovenous fistula (AVF) patency, the period of time during which an AVF remains open with adequate blood flow to enable hemodialysis. Vonapanitase is applied in a single administration and is currently being studied in two Phase 3 clinical trials in patients with chronic kidney disease (CKD) undergoing surgical creation of a radiocephalic AVF for hemodialysis. Vonapanitase has received fast track and orphan drug designations from the
Cautionary Note Regarding Forward-Looking Statements
This press release contains statements that are, or may be deemed to be, "forward-looking statements." In some cases these forward-looking statements can be identified by the use of forward-looking terminology, including the terms "believes," "estimates," "anticipates," "expects," "plans," "intends," "may," "could," "might," "will," "should," "approximately," "potential," or, in each case, their negatives or other variations thereon or comparable terminology, although not all forward-looking statements contain these words. These statements, including those regarding whether Proteon will continue clinical investigation of vonapanitase in PAD in 2016, the potential surgical and endovascular applications for vonapanitase, the potential for vonapanitase to provide a clinical benefit for patients with PAD, the potential treatment of renal and vascular diseases with vonapanitase, whether vonapanitase will improve AVF patency and those relating to future events or our future financial performance or condition, involve substantial known and unknown risks, uncertainties and other important factors that may cause our actual results, levels of activity, performance or achievements to differ materially from those expressed or implied by these forward-looking statements. These risks, uncertainties and other factors, including whether our cash resources will be sufficient to fund our operating expenses and capital expenditure requirements for the period anticipated; whether data from early clinical trials will be indicative of the data that will be obtained from future clinical trials; whether vonapanitase will advance through the clinical trial process on the anticipated timeline and warrant submission for regulatory approval; whether such a submission would receive approval from the