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UroGen Announces First Patient Dosed in Phase 1 Trial of UGN-501, an Investigational Next-Generation Oncolytic Virus for Non-Muscle Invasive Bladder Cancer

URGN
  • UroGen Pharma Ltd. announced that the first patient was dosed with UGN-501, a next-generation investigational oncolytic virus, in a Phase 1 clinical trial.
  • The trial evaluates the safety, tolerability, feasibility, & pharmacokinetics of local intravesical administration of UGN-501 in adults with recurrent non-muscle invasive bladder cancer (NMIBC).
  • Participants will receive an aqueous formulation of UGN-501 via six once-weekly intravesical instillations during a 12-week induction period following tumor resection.
  • Patients with no evidence of disease at week 12 may proceed to maintenance treatment consisting of three once-weekly instillations administered quarterly from month 3 through month 12.
  • The Phase 1, open-label, dose-escalation trial aims to determine the recommended Phase 2 dose for NMIBC, including high-grade Ta/T1 disease, carcinoma in situ (CIS), or low-grade Ta/T1 disease.
  • UGN-501 is designed to selectively replicate within tumor cells to cause direct destruction & stimulate an anti-tumor immune response.
  • Nonclinical studies are being conducted in parallel to explore a proprietary RTGel formulation of UGN-501, though the current Phase 1 trial utilizes an aqueous formulation without RTGel.
  • The trial is registered on ClinicalTrials.gov under identifier NCT07725796.