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4 个月前
BRIEF-Proteon Therapeutics announces increase to enrollment of ongoing phase 3 Patency-2 clinical trial
2017年5月2日 / 晚上9点48分 / 4 个月前

BRIEF-Proteon Therapeutics announces increase to enrollment of ongoing phase 3 Patency-2 clinical trial

May 2 (Reuters) - Proteon Therapeutics Inc

* Proteon Therapeutics announces increase to enrollment of ongoing phase 3 Patency-2 clinical trial

* Proteon Therapeutics Inc - Will increase planned enrollment of its ongoing phase 3 Patency-2 trial to 600 patients

* Proteon Therapeutics Inc- Increase in sample size does not alter study endpoints, which use same definitions as in Patency-1 trial

* Proteon - Increased sample size follows review of statistical plan, which revealed calculation error that overstated trial's power for secondary patency

* Proteon Therapeutics Inc says still expects to submit a biologics license application (BLA) to U.S. Food and Drug Administration (FDA) in 2019.

* Expects to complete enrollment in Q1 of 2018 for phase 3 Patency-2 trial and to report top-line data in Q1 of 2019 Source text for Eikon: Further company coverage:

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