Proteon Therapeutics Announces Overview of Phase 1 Clinical Program of Investigational Vonapanitase in Peripheral Artery Disease to be Presented at the 28th Transcatheter Cardiovascular Therapeutics (TCT) Conference
The presentation entitled, "Arterial Dilatation with Recombinant Human Elastase: A Novel Approach to Treating Peripheral Vascular Disease," will be given by Dr.
"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 will discuss the Company's two planned Phase 1 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.
About Peripheral Artery Disease (PAD)
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 twelve 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 3 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 1 clinical trial with vonapanitase in patients with peripheral artery disease (PAD). 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 "estimates," "anticipates," "expects," "plans," "intends," "may," or "will," in each case, their negatives or other variations thereon or comparable terminology, although not all forward-looking statements contain these words. These statements, including the potential treatment of PAD with vonapanitase, whether vonapanitase improves the durability of treatment for PAD or reduces the symptoms of PAD, the timing of future clinical studies in PAD of vonapanitase, including the initiation of two Phase 1 clinical studies in 2016, 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 nonclinical or clinical studies 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 U.S. Food and Drug Administration or equivalent foreign regulatory agencies on a timely basis or at all; and whether we can successfully commercialize and market our product candidates, are described more fully in our Annual Report on Form 10-K for the year ended
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