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Outcome Analysis 8-19 Months After Single Treatment With Transrectal NX-1207 in Multi-Center Prospective Blinded Randomized Placebo Controlled Study of Men With Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia
Barrett Cowan*1, Kevin Cline*2, Barton Wachs3, Sheldon Freedman4, Susan Jones Kalota5, Neal Shore6
1Urology Associates of Denver, Denver, CO;2Regional Urology, Shreveport, LA;3Atlantic Urology Medical Group, Long Beach, CA;4Freedman Urology, Las Vegas, NV;5Arizona Urologic Specialists, Tucson, AZ;6Carolina Urologic Research Center, Myrtle Beach, SC
Introduction and Objective: NX-1207 is an investigational drug for lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH). NX-1207 is a novel prostate selective therapeutic protein which causes controlled atrophy of prostate tissue. A Phase 2 multi-center, prospective, randomized, double-blind study was undertaken to assess safety and efficacy of NX-1207 in patients with LUTS due to BPH. Subjects and investigators remained blinded for 8-19 months after injection.
Methods: 116 unselected men from the trial with BPH-related LUTS from 26 U.S. clinical sites were available for follow-up.
NX-1207 was injected transrectally and bilaterally within the prostatic parenchyma. Each injection cohort received 10 mL (5 mL per lobe) at 3 dose levels (2.5 mg, 5 mg, 10 mg) and the 4th cohort received vehicle (placebo) alone. Efficacy was evaluated at 8-19 months.
Results: AUASS improvement in all NX-1207-treated patients at 8-19 months was 7.4 (p=0.0283) (vs 4.2 placebo) with the best results in the 5 mg group (8.7, p=0.005). In the initial evaluation and follow-up period, there were no serious adverse events in any patients receiving NX-1207 (N=81). There were no sexual side effects attributable to the study drug.
Conclusions: NX-1207 treatment for LUTS due to BPH involves an office based single ultrasound guided transrectal bilateral injection procedure involving only a few minutes to administer, associated with minimal discomfort and no catheter requirement. Results at 8-19 months after a single treatment indicate statistically significant symptomatic improvement and a very acceptable safety profile.
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