Efficacy and Safety of a Single TRUS-guided Intraprostatic Injection of NX-1207 in Patients With LUTS Due to BPH

Inclusion Criteria:

• Signed informed consent;
• Age 45 or older;
• Medical history of LUTS/BPH
• Use of a marketed α-blocker for LUTS/BPH in the last 8 weeks;
• LUTS/BPH not adequately controlled by medical therapy with α-blockers;
• Presence of moderate-severe LUTS (IPSS ≥ 15) at screening and at baseline (after a 4week run-in period with tamsulosin 0.4 mg QD);
• Prostate Volume ≥ 30 mL and ≤ 70 mL (as assessed by TRUS);
• Qmax < 15 mL/sec based on a minimum void of 125 mL;
• Agree not to use any other approved or experimental BPH or overactive bladder (OAB)medication anytime during the core study;
• Agree to perform follow-up visits even in case of oral treatment discontinuationbefore study end;
• Satisfactory compliance to run-in medication at Visit 2 (baseline).

Exclusion Criteria:

• Previous surgical or invasive prostate treatments such as TURP, TUMT, TUNA, laser orany other minimally invasive treatment;
• Acute or chronic prostatitis or suspected prostatitis including chronic pain,intermittent pain or abnormal sensation in the penis, testis, anal or pelvic area inthe past 12 months;
• PSA ≥ 10 ng/mL. In case of a PSA between 4.0 and 10.0 ng/mL, prostate cancer must havebeen ruled out to the satisfaction of the clinical Investigator by an historicalbiopsy;
• Prostate or bladder cancer, history of pelvic irradiation;
• Active or recurrent urinary tract infections (more than 1 episode in the last 12months);
• History of neurogenic bladder or LUTS secondary to neurologic disease;
• Use of self-catheterization for urinary retention;
• Post-void residual urine volume > 200 mL;
• Haematuria which has not been appropriately evaluated to determine safe subjectparticipation;
• Renal insufficiency (serum creatinine >2.0 mg/dL);
• Liver insufficiency (any liver function tests [LFTs]>2x upper limit of normal [ULN]);
• Poorly controlled diabetes (type 1 or type 2), as determined by HbA1c >6% and/orglycosuria;
• Any bleeding disorder such as haemophilia, clotting factor(s) deficiency or bleedingdiathesis;
• Immunosuppressive disorders, such as Human Immunodeficiency (HIV) Virus, AcquiredImmune Deficiency Syndrome (AIDS), lymphoproliferative disorders;
• Acute or chronic intestinal disease, such as ulcerative colitis, Crohn's disease,acute gastroenteritis in the run-in period; acute painful perianal disorder;
• Unstable cardiovascular or cerebrovascular disease (including acute myocardialinfarction, unstable angina pectoris, by-pass, Percutaneous Transluminal CoronaryAngioplasty (PTCA), congestive heart failure NYHA Class III-IV, stroke, transientischemic attack and episodes of cardiac arrhythmia requiring treatment in the last 6months);
• Any condition that would interfere with the subject's ability to provide informedconsent, to comply with study instructions, or that might confound the interpretationof the study results, such as dementia, psychosis, manic depressive disorder,post-traumatic stress disorder, stroke, Alzheimer's, depression, psychiatric illness,history or current evidence of drug or alcohol abuse within the last 12 months etc.;
• Participation in a study of any investigational drug or device within the previous 6months;
• Hypersensitivity or contraindication to tamsulosin use;
• Use of prohibited medications that could endanger subjects performing theintraprostatic injection or that could interfere with the evaluation of studyparameters;
• Men planning to have children in the future;
• Any other condition that may interfere with the study or endanger the subject.