Phase 2 Study of NX-1207 for the Treatment of Benign Prostatic Hyperplasia (BPH) (Enlarged Prostate)

Official Title: “Phase 2 Multicenter Randomized Two Dose Level and Non-Inferiority Clinical Evaluation of Transrectal Administration of NX-1207 for the Treatment of BPH”

This completed study evaluated the safety and efficacy of two dose levels of NX-1207 for the treatment of BPH (benign prostatic hyperplasia) versus finasteride.

Subjects randomized to NX-1207 were blinded as to the dose level of NX-1207 they received.

Intervention(s) in this Clinical Trial

• Drug: 2.5 mg NX-1207
  • Therapeutic dose; single intraprostatic injection of 2.5 mg NX-1207
• Drug: 0.125 mg NX-1207
  • Low dose; single intraprostatic injection of 0.125 mg NX-1207
• Drug: finasteride
  • Active comparator; 5.0 mg finasteride p.o. q.d. for duration of study (180 days)

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Single therapeutic dose of 2.5 mg NX-1207
• Experimental: 2
  • Single low dose of 0.125 mg NX-1207 for dose-response evaluation
• Active Comparator: 3
  • 5.0 mg finasteride q.d.

Primary Measures

• Change in BPH Symptom Score (AUA SI)
  • Time Frame: 90 days
    Safety Issue?: No

Secondary Measures

• Change in Prostate Volume
  • Time Frame: 90 days
    Safety Issue?: No
• Change in Qmax
  • Time Frame: 90 days
    Safety Issue?: No
• Change in BPH Symptom Score (AUA SI)
  • Time Frame: 30 days
    Safety Issue?: No
• Change in BPH Symptom Score (AUA SI)
  • Time Frame: 180 days
    Safety Issue?: No
• Number of Participants with Adverse Events, duration and severity of Adverse Events and relation, if any, to drug
  • Time Frame: 180 days
    Safety Issue?: Yes

Inclusion Criteria:

• 1. Documented history of BPH for at least 1 year
• 2. AUA SI ≥ 15
• 3. Prostate Volume ≥ 30 mL ≤ 70 mL
• 4. Qmax < 15 mL/sec

Exclusion Criteria:

• 1. History of illness or condition that may interfere with study or endanger subject
• 2. Use of prescribed medications that may interfere with study or endanger subject
• 3. Presence of a median lobe of the prostate
• 4. Surgery or MIST in the previous 12 months for treatment of BPH
• 5. Post-void residual urine volume > 350 mL
• 6. PSA ≥ 10 ng/mL; prostate cancer must be ruled out for PSA ≥ 4 ng/mL

Gender Eligibility for this Clinical Trial: Male

Minimum Age for this Clinical Trial: 45 Years

Maximum Age for this Clinical Trial: 75 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Nymox Corporation Industry

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00759135

Study ID Number: NX02-0016

ClinicalTrials.gov Identifier: NCT00759135

Health Authority: United States: Food and Drug Administration