The arduous process to prove that a drug works — so far taking 14 years and about $170 million — is being pushed ahead by Proteon Therapeutics.
The company, founded in the Kansas City area by Nicholas Franano and Bill Whitaker, has enrolled its first patient in its second phase 3 clinical trial, supervised by Christie Wynette Gooden, a surgeon at St. Luke’s Hospital in Kansas City.
The clinical trials are essential steps to gain Food and Drug Administration approval for vonapanitase, the drug being developed by Proteon. The drug, initially introduced under the name PRT-201, is a recombinant protein that is designed to act as a biological stent to maintain vascular access in hemodialysis patients.
The company is now based in Waltham, Mass., headed by chief executive Timothy Noyes, and trades on Nasdaq under the symbol PRTO.
“Proteon has a chance to make a difference,” Noyes said Tuesday, explaining that one of the problems with current hemodialysis procedures is that the vascular access site often fails over time.
“Unlike virtually all drugs, our treatment is only once,” Noyes said. “The treatment is given at the time of the surgery when the fistula (the access site for hemodialysis) is created.”
Two phase 3 clinical trials with 300 patients each are being conducted before Proteon expects to submit a biologic license application to the FDA in 2017 or later. About 40 hospitals around the country will be involved in each of the two phase 3 clinical studies.
In the trials, two-thirds of hemodialysis patients, selected in random, blind samples, take vonapanitase and one-third take a placebo. The eventual results will show whether the drug reduces the failure rate of vascular access.