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Multi-Center Prospective Randomized Double-Blind Study of Single-Injection Transrectal NX-1207 in Men With Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia.
Neal D. Shore, MD1, Sheldon J. Freedman, MD2, Susan Jones Kalota, MD3, Barton H. Wachs, MD4, Barrett Edward Cowan, MD5, Kevin Cline, MD6.
1Carolina Urologic Research Center, Myrtle Beach, SC, USA, 2Sheldon J. Freedman MD, Ltd., Las Vegas, NV, USA, 3Arizona Urologic Specialists, Tucson, AZ, USA, 4Atlantic Urology Medical Group, Long Beach, CA, USA, 5Urology Associates, Denver, CO, USA, 6Regional Urology, LLC, Shreveport, LA, USA.
BACKGROUND: 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.
METHODS: 175 men with BPH-related LUTS were enrolled from 43 U.S. clinical sites.
AUA Symptom Score (AUASS) ≥ 15; Qmax < 15mL/sec; and prostate volume ≥ 40 cc. Patients with retention, diabetes, and very large prostates (> 100 cc) were also included. Under transrectal ultrasound guidance, 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. Safety and efficacy were evaluated at 30 and 90 days.
RESULTS: There were no serious adverse events in any patients receiving NX-1207 (N=113). In NX-1207 treated patients with prostate volume < 79 cc, without pre-existent retention, diabetes, or use of immunosuppressants, there were 1.8% UTI (vs 4.8% placebo) and 0% retention or catheterization (vs 0% placebo). There were no sexual side effects attributable to the study drug. AUASS improvement in all drug-treated patients at 90 days was 9.35 (p=.017), (vs 6.5 placebo) with the best results in the 2.5 mg group (11.03, p <.008). Prostate volume loss 3 months post treatment was 6.84 cc or 11.7% (p <.017), (vs 3.1 g placebo). Qmax improvement was + 2.2 mL/sec (N.S.), (vs 1.5 mL/sec placebo).
CONCLUSIONS: NX-1207 treatment for LUTS due to BPH involves an office based single transrectal needle injection procedure requiring only a few minutes to administer, associated with minimal discomfort and no need for catheterization. Results at 90 days indicate significant symptomatic improvement, with a very acceptable safety profile. Continuing follow-up evaluation is underway to assess longer-term (≥ 1 year) outcomes; more long-term data are required to confirm treatment benefit.
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