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First Patient Dosed in UroGen Pharma’s Home Instillation Study of UGN-102 in Patients with Low-Grade Intermediate Risk Non-Muscle Invasive Bladder Cancer (LG IR-NMIBC)
Study explores opportunity to shift from clinic to home instillation of this promising non-surgical treatment Potential to transform care and access to
About this update from Urogen Pharma Ltd.
[{"type":"text","content":"\nStudy explores opportunity to shift from clinic to home instillation of this promising non-surgical treatment\n\nPotential to transform care and access to treatment for this growing patient population\n\n PRINCETON, N.J.--(BUSINESS WIRE)--\nUroGen Pharma Ltd. (Nasdaq: URGN), a biopharmaceutical company dedicated to building and commercializing novel solutions that treat urothelial and specialty cancers, today announced that the first patient has received their first dose in its home instillation study of UGN-102 in patients with low-grade, intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC).\n\nThe objective of this Phase 3b study, which aims to enroll up to ten patients across four centers, is to demonstrate whether UGN-102 can be administered at home by a qualified home health professional, avoiding the need for repeated visits to a healthcare setting for instillation.\n\n“The ease of UGN-102 instillation is of great benefit to these patients who are generally older, suffer from multiple comorbidities, and often rely on caregivers to drive them to medical appointments,” said Mark Schoenberg, M.D., Chief Medical Officer of UroGen. “Home instillation is especially convenient for the patient and less burdensome for caregivers as they navigate persistent challenges caused by repeated medical appointments. We look forward to demonstrating the versatility of UGN-102 in this study as we prepare to initiate the single-arm, pivotal Phase 3 ENVISION Study of UGN-102 in early 2022.”\n\nPatients in the ongoing Phase 3b study will receive six once-weekly intravesical instillations of UGN-102. The initial treatment visit will occur at the investigative site and instillation will be performed by a qualified physician. Treatment visits two to six will take place at the patient's home and instillation will be performed by a properly trained and qualified home health professional. The primary endpoint of the study is the incidence of treatment-emergent adverse events (TEAEs), serious TEAEs, TEAEs of special interest, discontinuations from at home study treatment, and clinically significant abnormalities in laboratory tests (hematology, serum chemistry, and urinalysis).\n\nAbout UGN-102 (mitomycin for intravesical solution)\nUGN-102 consists of mitomycin and sterile hydrogel (a proprietary thermally responsive gel) that is used ...