Phase 3 Evaluation of Re-Injection of NX-1207 for the Treatment of Benign Prostatic Hyperplasia (BPH)

Phase 3 Multicenter Prospective Open Label Clinical Safety Evaluation of Re-Injection of NX-1207 for the Treatment of BPH: Two Doses 1-7 Years Apart

This study is designed to demonstrate the safety and efficacy of a second transrectal intraprostatic injection of NX-1207 given to subjects with Benign Prostatic Hyperplasia (BPH) who previously received an injection of NX-1207 in an earlier U.S. clinical trial of NX-1207.

Inclusion Criteria:

• Be male aged 45 or older.
• Sign an informed consent form.
• Be in good health.
• Received NX-1207 in a previous completed study or received NX-1207 or placebo in a concurrent U.S. study (NX02-0017 and NX02-0018) and completed their V10 (365 day) visit.
• Have Prostate Gland Volume ≥ 25 mL (25 g).

Exclusion Criteria:

• Surgery or minimally invasive surgical therapy (MIST) for treatment of BPH after first NX-1207 injection
• Post-void residual urine volume > 200 mL
• Presence of a symptomatic median lobe of the prostate
• History of use of self-catheterization for urinary retention.
• Urinary retention in the previous 12 months.
• Prostatitis
• Urinary tract infection more than once in the past 12 months
• Prostate or bladder cancer.
• PSA ≥10 ng/mL
• Poorly controlled diabetes
• History or evidence of illness or condition that may interfere with study or endanger subject
• Participation in a study of any investigational drug (other than NX-1207) or investigational device within the previous 90 days
• Use of specific prescribed medications that may interfere with study or endanger subject