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Proteon adjusts PATENCY-2 trial
May 2017
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WALTHAM, Mass.—As the first quarter ended, Proteon Therapeutics Inc. shared its financial results for full-year 2016, as well as an update on its PATENCY-2 trial for vonapanitase. This trial is the second Phase 3 clinical study of the investigational drug, with results from the first Phase 3 trial released in December 2016. After reviewing data from that trial, Proteon entered discussions with the FDA regarding protocol for PATENCY-2, and made several changes, including reordering the trial endpoints by making secondary patency and fistula use for hemodialysis co-primary endpoints and increasing planned enrollment from 300 to 500 patients. In addition, given the talks with the FDA, Proteon feels that, pending statistical significance in PATENCY-2 for each co-primary endpoint, the PATENCY-2 data and data from other completed studies could form the basis for a Biologics License Application and remove the need for additional studies.

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