On April 5, 2019 UroGen Pharma Ltd. (Nasdaq: URGN), a clinical-stage biopharmaceutical company developing treatments to address unmet needs in uro-oncology, reported a new presentation from the pivotal Phase 3 OLYMPUS trial of UGN-101 (mitomycin gel) for instillation, an investigational formulation for the primary non-surgical treatment of patients with low-grade upper tract urothelial cancer (LG UTUC) (Press release, UroGen Pharma, APR 5, 2019, View Source [SID1234535020]). The analysis, which discusses the minimally invasive chemoablation approach of UGN-101 to potentially treat LG UTUC tumors, including those that are unresectable, will be presented on Sunday, May 5, 2019 in an oral presentation during the plenary session at the 114th American Urological Association (AUA) Annual Meeting in Chicago. The text for the abstract is available online through the Journal of Urology website.
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Details of AUA Oral Presentation
Abstract #: LBA-16
Session: Plenary Session, Next Frontier
Title: Nephron-sparing Management of Low Grade (LG) UTUC With UGN-101 (mitomycin gel) for Instillation: The Olympus Trial Experience
Presenter: Seth Paul Lerner, M.D., FACS, Professor of Urology, Baylor College of Medicine
Date and Time: Sunday, May 5, 2019; 3:17 – 3:26 PM CDT
Location: MCP: W375d
"The treatment of LG UTUC remains a technical challenge for urologists, given the anatomical complexity of the kidney and the physical limits of endoscopic instrumentation," said Mark P. Schoenberg, M.D., Chief Medical Officer of UroGen. "UroGen is committed to raising the standard of care for this typically elderly patient population whose current options consist of repetitive endoscopic surgical intervention or complete loss of a kidney. We look forward to presenting this UGN-101 analysis that further underscores the unmet need in patients with new and recurrent LG UTUC."
About UGN-101
UGN-101 (mitomycin gel) for instillation is an investigational drug formulation of mitomycin in Phase 3 development for the treatment of low-grade upper tract urothelial cancer (LG UTUC). Utilizing the RTGel technology platform, UroGen’s proprietary sustained release, hydrogel-based formulation, UGN-101 is designed to enable longer exposure of urinary tract tissue to mitomycin, thereby enabling the treatment of tumors by non-surgical means. UGN-101 is delivered to patients using standard ureteral catheters. The Company initiated its rolling submission of the UGN-101 New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in December 2018. The FDA previously granted Orphan Drug, Fast Track, and Breakthrough Therapy Designations to UGN-101 for the treatment of UTUC. If approved, UGN-101 would be the first drug approved for the non-surgical treatment of LG UTUC.