UroGen Pharma to Host Thought Leader Webinar on UGN-102 and Non-Muscle Invasive Bladder Cancers
-- UGN-102 is an Investigational Formulation of the Novel RTGel™ Delivery Technology Combined with Mitomycin in Phase 3 Development for the Treatment of Low-Grade Intermediate Risk NMIBC --
-- Webinar scheduled for
The webinar will feature presentations from key opinion leaders
UroGen leadership will provide insight into their pipeline portfolio, highlighting the Company’s Phase 3 clinical program of UGN-102, an investigational therapeutic that utilizes UroGen’s innovative technology, RTGel™ reverse-thermal hydrogel, and mitomycin for the potential treatment of LG-IR-NMIBC.
A live Q&A session will follow the formal presentations. To register for the event, please click here.
Out of the 80,000 estimated cases of bladder cancer per year in the
UGN-102 (mitomycin) for intravesical solution is an investigational drug formulation of mitomycin in Phase 3 development for the treatment of low-grade intermediate risk NMIBC. Utilizing RTGel™ Technology, UroGen’s proprietary sustained release, hydrogel-based formulation, UGN-102 is designed to enable longer exposure of bladder tissue to mitomycin, thereby enabling the treatment of tumors by non-surgical means. UGN-102 is delivered to patients using a standard urinary catheter. The Company presented results from the Phase 2b OPTIMA II trial in
About the Phase 3 ENVISION Trial
The Phase 3 ENVISION trial is a multinational, multicenter single-arm study evaluating the efficacy and safety of UGN-102 (mitomycin) as primary chemoablative therapy in patients with low-grade, intermediate-risk NMIBC. The Phase 3 ENVISION trial is expected to enroll approximately 220 patients across 90 sites and study participants will receive six once-weekly intravesical instillations of UGN-102. The planned primary endpoint will evaluate the complete response rate at three months after the first installation, and the key secondary endpoint will evaluate durability over time in patients who achieve complete response at the three-month assessment. Based on discussions with the FDA, and enrollment expected by the end of 2022, assuming positive findings, UroGen anticipates submitting an NDA for UGN-102 in 2024.
UroGen is biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers because patients deserve better options. UroGen has developed RTGel™ reverse-thermal hydrogel, a proprietary sustained release, hydrogel-based platform technology that has the potential to improve therapeutic profiles of existing drugs. UroGen’s sustained release technology is designed to enable longer exposure of the urinary tract tissue to medications, making local therapy a potentially more effective treatment option. UroGen’s first commercial product and investigational treatment UGN-102 (mitomycin) for intravesical solution for patients with low-grade non-muscle invasive bladder cancer, are designed to ablate tumors by non-surgical means. UroGen is headquartered in
This press release contains forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995, including, without limitation, statements regarding the enrollment expectations for the single-arm Phase 3 ENVISION study for UGN-102 and the timing thereof; the timing, design and potential success of the ENVISION study; the timing of the planned NDA submission for UGN-102; RTGel’s potential to improve the therapeutic profiles of existing drugs; UroGen’s sustained release technology making local delivery a potentially more effective treatment option; and the design of UroGen’s product and product candidates. Words such as “anticipate,” “designed to,” “expect,” “plan,” “potential,” “will” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements necessarily contain these identifying words. These statements are subject to a number of risks, uncertainties and assumptions, including, but not limited to: any negative effects on UroGen’s business, commercialization and product development plans caused by or associated with COVID-19; the timing and success of clinical trials and potential safety and other complications thereof; the ability to obtain and maintain regulatory approval; the labelling for any approved product; competition in our industry; and the sufficiency of our capital resources. In light of these risks and uncertainties, and other risks and uncertainties that are described in the Risk Factors section of UroGen’s Form 10-Q filed with the
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Director, Corporate Communications
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