Study Suggests Benefit of Proteon Therapeutics' PRT-201 for PAD

January 8, 2015—Proteon Therapeutics Inc. announced the publication of nonclinical data on PRT-201 (vonapanitase), an investigational recombinant human elastase, for peripheral arterial disease (PAD). The company noted that elastase has been shown in preclinical settings to reduce neointimal hyperplasia formation, which may result in improved blood flow and prolonged vessel patency. 

This ex vivo study evaluated the effect of a single treatment of PRT-20 on atherosclerotic human arteries. The company stated that the positive results support Proteon’s clinical development program in PAD. Steven K. Burke, MD, et al published the findings in the Journal of Cardiovascular Pharmacology (2014;64:530–535). Dr. Burke is Proteon’s Senior Vice President and Chief Medical Officer.

In the Journal of Cardiovascular Pharmacology, the investigators concluded, “The results suggest that PRT-201 treatment of atherosclerotic peripheral arteries in patients could increase artery diameter, and thus luminal area, possibly alleviating some of the symptoms of PAD.”

Proteon stated that PRT-201 has received fast-track and orphan drug designations from the US Food and Drug Administration and orphan medicinal product designation from the European Commission for hemodialysis vascular access indications.

Noting that these data support the company’s belief that PRT-201 may have multiple surgical and endovascular applications in addition to its application in hemodialysis vascular access, the company advised that in the second half of 2015, it expects to have the results of the phase 1 study evaluating endovascular treatment with PRT-201 for patients with PAD.
 
According to Proteon Therapeutics, PRT-201 has the potential to treat patients affected with a number of renal or vascular diseases for which there currently are limited therapeutic options. These results support the ongoing phase 1 clinical study of PRT-201, which enrolled patients with symptomatic PAD of the superficial femoral or popliteal artery. Immediately after angioplasty, patients received PRT-201 delivered to the arterial wall via a catheter-based approach using the Bullfrog microinfusion device (Mercator MedSystems, Inc.).

Proteon’s lead clinical program is evaluating whether PRT-201 can prolong the patency and reduce the failure of hemodialysis vascular access in patients with chronic kidney disease. Proteon is currently conducting a phase 3 multicenter, randomized, double-blind, placebo-controlled, 300-patient clinical study of PRT-201 in chronic kidney disease patients undergoing surgical placement of an arteriovenous fistula for hemodialysis vascular access. The phase 3 study follows the completion of a phase 2 multicenter, randomized, double-blind, placebo-controlled clinical study in which 151 patients were treated, advised Proteon Therapeutics.