Data in Journal of Vascular Surgery Demonstrate Potential to Improve Function and Durability of Vascular Access Required for Hemodialysis
May 14, 2014
Proteon Therapeutics Inc., a privately held biopharmaceutical company developing novel, first-in-class pharmaceuticals to address the critical medical needs of patients with kidney and vascular diseases, today announced the online publication of data from a Phase 2 clinical study of the company’s lead product, PRT-201, in the Journal of Vascular Surgery. Proteon is investigating the use of PRT-201 to prolong the patency and reduce the failure of hemodialysis vascular access in patients with chronic kidney disease (CKD). These data indicate that PRT-201 may improve the function and durability of arteriovenous fistulas (AVFs), the optimal form of vascular access for hemodialysis patients. PRT-201 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.
“Hemodialysis patients frequently suffer from AVF failure, which leads to additional procedures and increases the risk of serious complications,” said Robert Hye, M.D., Chief of Vascular Surgery of Kaiser Permanente, Southern California Permanente Medical Group, and lead author of the publication. “These data demonstrate that treatment with PRT-201 could improve the function and longevity of AVFs for hemodialysis patients.”
PRT-201 is a locally-acting recombinant human elastase delivered to the external surface of the artery and vein during surgical creation of an AVF. A single treatment of PRT-201 may increase the longevity of an AVF, reducing the need for additional corrective surgical and interventional procedures. In this 151-patient, Phase 2 clinical trial, PRT-201 was well-tolerated and demonstrated improvement in key measures of AVF function. These improvements included an increased percentage of AVFs that developed adequate blood flow for dialysis without the need for an intervention within 12 weeks of creation (unassisted maturation) and a decrease in the percentage of AVFs that developed a thrombosis or required a procedure to restore or maintain patency within one year (loss of primary unassisted patency). The results are described in a paper entitled, “Human type I pancreatic elastase treatment of arteriovenous fistulas in patients with chronic kidney disease”, currently available on the website of the Journal of Vascular Surgery.
The Phase 2 study was the third multicenter, double-blind, placebo-controlled trial of PRT-201 that Proteon has conducted in patients undergoing surgical placement of a vascular access. Based on the results of this study, Proteon plans to initiate a Phase 3 study in 2014.
“The results of this Phase 2 study give us high confidence in our Phase 3 clinical trial strategy,” said Timothy Noyes, President and Chief Executive Officer of Proteon. “The data demonstrate that PRT-201 has the potential to provide meaningful benefit to CKD patients undergoing surgical placement of an AVF for hemodialysis.”
A functioning vascular access is a hemodialysis patient’s lifeline, enabling the patient to undergo hemodialysis. Unfortunately, AVFs and arteriovenous grafts (AVGs), the two forms of permanent vascular access, often experience patency loss, in which the access suffers from a significant reduction in or complete loss of blood flow, precluding hemodialysis. Patency loss leads to surgical or interventional procedures to restore blood flow, and can result in access abandonment and prolonged exposure to dialysis catheters.
Proteon is also investigating PRT-201 as a treatment for patients with symptomatic Peripheral Artery Disease (PAD) and is currently enrolling patients in the U.S. in a Phase 1 clinical study.
PRT-201 is an investigational recombinant human elastase that is being studied for its ability to improve outcomes in patients suffering from vascular disease. Elastase has been shown in preclinical settings to reduce neointimal hyperplasia formation and to cause dilation of segments of arteries and veins. These effects may inhibit stenosis formation and increase vessel diameter, improving blood flow and prolonging vessel patency. PRT-201 has received fast track and orphan drug designations from the FDA and orphan medicinal product designation from the European Commission for hemodialysis vascular access indications.
About Proteon Therapeutics
Proteon Therapeutics Inc. is a privately held biopharmaceutical company developing novel, first-in-class pharmaceuticals to address the critical medical needs of patients with kidney and vascular diseases. The company is headquartered in Waltham, Mass. For additional information, please visitwww.proteontherapeutics.com.