Re: Phase 1 and 2 studies demonstrate the safety and efficacy of intraprostatic injection of PRX302 for the targeted treatment of lower urinary tract symptoms secondary to benign prostatic hyperplasia

摘要

Background: PKX302 is a prostate specific antigen (PSA)-activated pore-forming protein toxin under development as a targeted approach for improving lower urinary tract symptoms (LUTS) caused by benign prostatic hyperplasia (BPH) without affecting sexual function. Objective: To evaluate the safety and efficacy of PRX302 in men with moderate to severe BPH. Design, Setting, and Participants: Eligible subjects were refractory, intolerant, or unwilling to undergo medical therapies for BPH and had International Prostate Symptom Score (IPSS) >=12, a quality of life (QoL) score >=3, and prostate volumes between 30 and 80 g. Fifteen patients were enrolled in phase 1 studies, and 18 patients entered phase 2 studies. Interventions: Subjects received intraprostatic injection of PRX302 into the right and left transition zone via a transperineal approach in an office-based setting.