AUA 2018: Results from Interim Analysis of Pivotal Phase 3 Trial of UGN-101 for Non-Surgical Treatment of Upper Tract Urothelial Cancer

San Francisco, CA (UroToday.com) -- UroGen Pharma Ltd., a clinical-stage biopharmaceutical company developing treatments to address unmet needs in the field of urology, with a focus on uro-oncology,  announced a new data presentation from an interim analysis of the ongoing pivotal Phase 3 OLYMPUS clinical trial of UGN-101 (MitoGel™), an investigational mitomycin formulation for the non-surgical treatment of low-grade upper tract urothelial cancer (UTUC). The full interim analysis will be presented on Monday, May 21, 2018 in an oral presentation during the plenary session at the 113th American Urological Association's (AUA) Annual Meeting in San Francisco.

Details of the AUA Oral Presentation
Abstract #: LBA-25 
Session: Plenary, Next Frontier
Title: Non-Surgical Management of Low Grade Upper Tract Urothelial Cancer: An Interim Analysis of the International Multicenter OLYMPUS Trial
Presenter: Seth Paul Lerner, M.D., FACS, Professor of Urology, Baylor College of Medicine
Time: Monday, May 21, 2018, 10:40-10:50 AM PDT
Location: MCC NORTH, Hall E, The Moscone Center

"We look forward to presenting data from the OLYMPUS trial of our lead product candidate, UGN-101, for the treatment of patients with low-grade UTUC," said Ron Bentsur, Chief Executive Officer of UroGen.

"With UGN-101, we hope to change the treatment paradigm for low-grade UTUC and potentially reduce the high recurrence rate characteristic of UTUC, while eliminating the need for surgery and the risks associated with surgery. Our goal is for UGN-101 to become the first-ever approved treatment for low-grade UTUC."
The OLYMPUS trial continues to enroll patients, and top-line results are expected in the third quarter of 2018.


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A Phase 3 Multicenter Trial Evaluating the Efficacy and Safety of MitoGel™ on Ablation of Upper Urinary Tract Urothelial Carcinoma