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news.Proteon Therapeutics has dosed the first patient in a second Phase III clinical trial of its investigational lead product candidate (formerly PRT-201) to treat vonapanitase in patients with chronic kidney disease (CKD) undergoing surgical creation of a radiocephalic arteriovenous fistula (AVF) for hemodialysis.
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Vonapanitase is an investigational drug that may prolong the patency and reduce the failure of hemodialysis vascular access in patients with CKD.
The new trial complements the first Phase III study, which was started in July 2014 and is expected to complete enrollment by the end of this year.
Both Phase III trials are evaluating the safety and efficacy of a single treatment of vonapanitase, a locally acting recombinant human elastase, in these patients.
Around 300 patients will be enrolled in the second randomized, double-blind, placebo-controlled Phase III trial at about 40 centers in the US and Canada.
The company noted that immediately after surgical creation of a radiocephalic AVF, each patient will be given either 30 micrograms of vonapanitase or placebo, delivered in a single, local administration to the external surface of the AVF.
Proteon president and chief executive officer Timothy Noyes said: "Initiating the second Phase 3 study of vonapanitase is a significant achievement for 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."
The company is also conducting an ongoing Phase I trial of vonapanitase in patients with symptomatic peripheral artery disease (PAD).