BioCentury
ARTICLE | Clinical News

Proteon reports Phase II data for PRT-201 in CKD patients

January 4, 2013 12:51 AM UTC

Proteon Therapeutics Inc. (Waltham, Mass.) said PRT-201 missed the primary endpoint in a Phase II trial to improve vascular access in chronic kidney disease (CKD) patients undergoing surgery for arteriovenous fistula (AVF) creation. Specifically, PRT-201 given immediately after AVF creation missed the primary endpoint of prolonging the duration of unassisted primary patency vs. placebo. Proteon said PRT-201 missed the endpoint due to an undisclosed baseline imbalance between treatment groups that the company said it does not believe would occur in a larger Phase III trial. PRT-201 did meet the secondary endpoint of improving the rate of AVF maturation vs. placebo. The double-blind, U.S. trial enrolled 151 patients. Proteon plans to hold an end-of-Phase II meeting with FDA to finalize the design and timeline of Phase III testing for PRT-201, but declined to disclose details. ...