Company Now Enrolling Patients in Two Phase 3 Studies Evaluating Safety and Efficacy of a Single Treatment of Investigational Vonapanitase in Patients With Chronic Kidney Disease Undergoing Surgical Creation of a Radiocephalic Arteriovenous Fistula for Hemodialysis
WALTHAM, Mass., Aug. 12, 2015 (GLOBE NEWSWIRE) -- Proteon Therapeutics Inc. (Nasdaq:PRTO), a company developing novel, first-in-class therapeutics to address the medical needs of patients with kidney and vascular diseases, today announced that the first patient has been treated in a second Phase 3 clinical study of investigational vonapanitase (formerly PRT-201), the company's lead product candidate.
The second Phase 3 study complements the first Phase 3 study, which was initiated in July 2014 and is expected to complete enrollment by the end of 2015. Both Phase 3 studies are evaluating the safety and efficacy of a single treatment of vonapanitase in patients with chronic kidney disease (CKD) undergoing surgical creation of a radiocephalic arteriovenous fistula (AVF) for hemodialysis. Vonapanitase, a locally acting recombinant human elastase, is an investigational drug that may prolong the patency and reduce the failure of hemodialysis vascular access in patients with CKD.
The first patient in the second Phase 3 study was enrolled at Saint Luke's Hospital of Kansas City, by Christie Wynette Gooden, M.D., Clinical Assistant Professor, Department of Surgery at the University of Missouri-Kansas City School of Medicine.
"One of the greatest challenges for patients with CKD is securing reliable, consistent vascular access for hemodialysis. A radiocephalic AVF is the preferred form of vascular access, which is a hemodialysis patient's lifeline," said Dr. Gooden. "Radiocephalic AVFs are at risk of reduced blood flow and patency loss, which results in additional corrective procedures and reduced AVF survival. There are no approved therapies currently available to prolong AVF patency, which we will be evaluating in this clinical study."
The second randomized, double-blind, placebo-controlled Phase 3 clinical trial will enroll 300 patients at approximately 40 centers in the United States and Canada. Immediately after surgical creation of a radiocephalic AVF, each patient will receive either 30 micrograms of vonapanitase or placebo, delivered in a single, local administration to the external surface of the AVF. The primary efficacy endpoint, measured over 12 months, is primary patency, the time from AVF creation until a thrombosis or a procedure to restore or maintain patency. The secondary efficacy endpoint, also measured over 12 months, is secondary patency, defined as the time from AVF creation until AVF abandonment.
"Initiating the second Phase 3 study of vonapanitase is a significant achievement for Proteon," said Timothy Noyes, President and Chief Executive Officer of Proteon. "Proteon has its roots in Kansas City and I am thrilled that a local institution enrolled the first patient in this important clinical study evaluating a potential new treatment for patients requiring vascular access."
Proteon is also conducting an ongoing Phase 1 clinical study of vonapanitase in patients with symptomatic peripheral artery disease (PAD).
About Chronic Kidney Disease, Hemodialysis and Vascular Access
In the most severe stage of chronic kidney disease (CKD), also known as kidney failure, the kidneys can no longer function to sustain life. The majority of patients with kidney failure require hemodialysis and need a high-flow vascular access to repeatedly connect the patient's bloodstream to a hemodialysis machine for this life-saving, chronic treatment: Three times per week for three to four hours each session, blood is pumped from the body and passed through a dialysis machine that removes waste and excess water normally excreted by the kidneys. The preferred form of vascular access, used by two-thirds of hemodialysis patients in the United States, is an arteriovenous fistula (AVF). An AVF is created when a surgeon connects a vein to an artery, typically at the wrist or elbow, resulting in a substantial increase in blood flow and vein dilation. A radiocephalic AVF is created between the radial artery and cephalic vein at the wrist.
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 arteriovenous fistula for hemodialysis. Vonapanitase has received fast track and orphan drug designations from the U.S. Food and Drug Administration (FDA), and orphan medicinal product designation from the European Commission, for hemodialysis vascular access indications. Vonapanitase may have multiple surgical and endovascular applications in which vessel injury leads to blockages in blood vessels and reduced blood flow, and is currently being evaluated in a Phase 1 clinical trial in patients with symptomatic peripheral artery disease (PAD).
About Proteon Therapeutics
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 (formerly PRT-201), is designed 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 3 clinical trials in patients with chronic kidney disease (CKD) undergoing surgical creation of a radiocephalic arteriovenous fistula for hemodialysis and a Phase 1 clinical trial in patients with symptomatic peripheral artery disease (PAD). For more information, please visit www.proteontherapeutics.com.
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 the potential surgical and endovascular applications for vonapanitase, the timing of results of the Phase 1 study for patients with PAD, the potential treatment of renal and vascular diseases with vonapanitase, the effect of vonapanitase in patients with CKD and number of persons with CKD, timing of completing enrollment for the Phase 3 trials, 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 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 Quarterly Report on Form 10-Q for the quarter ended March 31, 2015, as filed with the Securities and Exchange Commission on May 13, 2015 and our Current Reports on Form 8-K, as filed with the SEC, particularly in the sections titled "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations." In light of the significant uncertainties in our forward-looking statements, you should not place undue reliance on these statements or regard these statements as a representation or warranty by us or any other person that we will achieve our objectives and plans in any specified time frame, or at all. The forward-looking statements contained in this press release represent our estimates and assumptions only as of the date of this press release and, except as required by law, we undertake no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise after the date of this press release.
George Eldridge, Senior Vice President and Chief Financial Officer
Chris Erdman or Lynnea Olivarez, MacDougall Biomedical Communications
Proteon Therapeutics Inc.