UroGen Pharma Announces Presentation of Results from Interim Analysis of Pivotal Phase 3 OLYMPUS Trial of UGN-101 (MitoGel™) for Non-Surgical Treatment of Upper Tract Urothelial Cancer (UTUC)
RA’ANANA,
Details of 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:
Time:
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
The OLYMPUS trial continues to enroll patients, and top-line results are expected in the third quarter of 2018.
About the Phase 3 OLYMPUS Trial
OLYMPUS (Optimized DeLivery of Mitomycin for Primary UTUC Study) is an open-label, single-arm Phase 3 clinical trial of UGN-101 (MitoGel) to evaluate the safety, tolerability and tumor ablative effect of UGN-101, an investigational formulation of mitomycin, in patients with low-grade UTUC. The trial, designed to be a single pivotal study for the approval of UGN-101 for the treatment of low-grade UTUC, is anticipated to enroll approximately 70 patients at clinical sites across
About Upper Tract Urothelial Cancer (UTUC)
Upper tract urothelial cancer (UTUC) involves the upper urinary tract, which connects the bladder to the kidney and renal pelvis. In
The current standard of care for UTUC is complete or partial surgical removal of the involved kidney and upper urinary tract. For patients with a bilateral disease, an anatomic or functionally solitary kidney, medical comorbidities or low-grade disease who present with a limited number of tumors, a kidney-conserving alternative is considered, if possible. However, due to the specific anatomy and physiology of the upper urinary tract and renal pelvis, organ-sparing endoscopic resection and instillation of neoadjuvant or adjuvant chemotherapy is often challenging, leading to high rates of recurrence. Additionally, continuous urine flow, the inability of the upper urinary tract to retain a liquid volume under normal circumstances, and the effects of peristalsis, or muscle contraction, result in short exposure time of active agents in the target area. This leads to poor efficacy and limited use of standard therapeutic agents in the treatment of UTUC.
About UGN-101 (MitoGel™)
UGN-101 is an investigational drug formulation of mitomycin in Phase 3 development for the treatment of low-grade UTUC. Utilizing RTGel™, UroGen’s proprietary sustained release, hydrogel-based formulation, UGN-101 is designed to enable longer exposure of mitomycin C to the urinary tract tissue, thereby potentially enabling the treatment of tumors by non-surgical means. UGN-101 is delivered to patients using standard intravesical catheters.
About
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 timing and results of clinical development and commercial prospects of the product candidates in UroGen’s pipeline, including UGN-101 (MitoGel) and UGN-102 (VesiGel), the scope and development of UroGen’s product candidate pipeline, enrollment in the OLYMPUS trial, timing and expectations of results from the OLYMPUS trial, UroGen’s expectations regarding its ability to fund its operations, and the ability of UroGen to become a leader in the field of uro-oncology, particularly in the treatment of low-grade UTUC, which statements are subject to a number of risks, uncertainties and assumptions, including, but not limited to: the timing and success of clinical trials and potential complications thereof, including with respect to enrollment; the ability to obtain and maintain regulatory approval; the labeling for any approved product; the scope, progress and expansion of developing and commercializing UroGen’s product candidates; and the size and growth of the market(s) therefor and the rate and degree of market acceptance thereof vis-à-vis alternative therapies. In light of these risks and uncertainties, and other risks and uncertainties that are described in the Risk Factors section of our annual report for the year ended
UROGEN CONTACTS:
Director,
KateB@urogen.com
914-552-0456