UroGen Pharma Announces Presentation of Analysis from Phase 3 OLYMPUS Trial of UGN-101 for Patients with Low-Grade Upper Tract Urothelial Cancer
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
Date
and Time:
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
Forward-Looking Statements
This press release contains forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995, including with respect to the potential of UGN-101 to be the first non-surgical therapy for LG UTUC, the completion of the rolling NDA for UGN-101, approval, launch and adoption of UGN-101, the potential of UroGen’s proprietary RTGel™ technology platform, and the potential of UGN-102, which statements are subject to a number of risks, uncertainties and assumptions, including, but not limited to: the timing and success of clinical trials, including the Olympus pivotal Phase 3 trial and potential safety and other complications thereof; the ability to obtain and maintain regulatory approval; the labeling for any approved product; the scope, progress and expansion of developing and commercializing UroGen Pharma’s product candidates; the size and growth of the market(s) therefor and the rate and degree of market acceptance thereof vis-à-vis alternative therapies; and UroGen Pharma’s ability to attract or retain key management, members of the board of directors and personnel. In light of these risks and uncertainties, and other risks and uncertainties that are described in the Risk Factors section of UroGen Pharma’s most recent Form 10-K filed with the SEC and other filings that UroGen Pharma makes with the SEC from time to time (which are available at http://www.sec.gov), the events and circumstances discussed in such forward-looking statements may not occur, and UroGen Pharma’s actual results could differ materially and adversely from those anticipated or implied thereby. Any forward-looking statements speak only as of the date of this press release and are based on information available to UroGen Pharma as of the date of this release.
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Source:
UROGEN:
Kate Bechtold
Director, Corporate
Communications & Investor Relations
Kate.Bechtold@urogen.com
914-552-0456