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Investigational Therapy UGN-102 May Be Delivered at Home for the Treatment of Bladder Cancer
--In a Small Feasibility Study, UGN-102 Achieves a Complete Response in 75% (6 of 8) Patients --UGN-102 is Being Studied in Low-Grade Intermediate-Risk
About this update from Urogen Pharma Ltd.
[{"type":"text","content":"\n--In a Small Feasibility Study, UGN-102 Achieves a Complete Response in 75% (6 of 8) Patients\n\n--UGN-102 is Being Studied in Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer\n\n PRINCETON, N.J.--(BUSINESS WIRE)--\nUroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced preliminary results of a study to assess the feasibility of home instillation of UGN-102 (mitomycin) for intravesical solution, an investigational therapy in development for primary chemoablation of low-grade, intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). In this study, UGN-102 was suitable to administer at home by a visiting nurse under the supervision of a treating physician and resulted in 75% of patients achieving a complete response, defined as no detectable disease 3 months after starting treatment.\n\n“Many bladder cancer patients are elderly and suffer from comorbidities that make frequent office visits for treatment a real burden,” said study investigator David Morris, M.D., F.A.C.S., Urologist at Urology Associates PC, Nashville, TN. “Moving healthcare out of the clinical setting and into a patient’s home would represent a new treatment paradigm for bladder cancer, which may reduce clinic and hospital costs while increasing patient comfort and convenience.”\n\nEight patients were enrolled and treated with UGN-102 by 4 investigators. Median age was 75 years (range 55-84). Six patients completed treatment (6 doses), and 2 patients discontinued the study (5 doses and 4 doses, respectively) due to adverse events (AEs) unrelated to treatment. All 8 patients were evaluable for treatment response, and 6 of 8 (75%) achieved a complete response 3 months after starting treatment. The 2 patients who discontinued were assessed as non-responders. Treatment-related AEs were mild to moderate in severity (most common: dysuria and fatigue in 2 patients), and 3 patients with significant comorbidities had a serious AE, all of which were unrelated to treatment with UGN-102.\n\nPatients, nurses and investigators completed home instillation feasibility questionnaires. These standardized feasibility questionnaires highlighted that all 8 patients preferred at-home to in-office treatment, and 5 of 6 patients recommende...