• Safety of Litx™ BPH System by Recording of Adverse Events; Preliminary effectiveness of Litx™ BPH System by evaluating the International Prostate Symptom Score (IPSS) along with Bother Score (BS). [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
  

• To assess the effect of the Litx™ treatment following tests by: Maximum urinary flow rate (Qmax); Post void residual volume (PVR); Transrectal ultrasound (TRUS) to measure prostate size and treatment effect. [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  

The eligible patients will be enrolled into one of the two Litx™ treatment Cohorts (A or B)

All patients will undergo the procedure of Litx™ BPH Device placement into the prostate urethra.

Following the placement of the Litx™ BPH Device into the urethra, patients in Cohort A will be administered an intravenous dose of LS11 (talaporfin sodium) at 1 mg/kg by slow push over 3 - 5 minutes. Fifteen minutes after injection, each patient will be administered a 50 J total light dose, delivered at 20 mW/cm over a 42 minute time period.

Following the placement of the Litx™ BPH Device into the urethra, patients in Cohort B will receive LS11 intravenously at 1 mg/kg by slow push over 3 to 5 minutes. The light activation procedure is the same as that for Cohort A except that a light dose of 70 J will be delivered to each patient over a 58 minute time period.

After 30 days, patients who have not experienced an improvement in symptoms, as determined by the investigator, may undergo an additional interventional therapy with continued follow-up per the protocol.

At the end of 4 weeks following treatment of the last patient in Cohort A, the number of patients requiring surgical intervention for relief of primary symptoms will be assessed for futility of the current protocol prior to commencing with treatment of the first patient in Cohort B.

Inclusion Criteria:

• Males, 50 years or older, who are on an alpha blocker and/or a 5-alpha reductase inhibitor or a combination, and are candidates for interventional therapy. Patients to continue on an alpha blocker and/or 5-alpha reductase inhibitor for at least one-month after the Litx™ treatment, then tapered off medication at physician's discretion.
• Patients who understand and have the ability to sign written informed consent prior to any study procedures and discontinuation of exclusionary medications.
• Patients with moderate to severe BPH bother score >3 requiring non-medication intervention.2,3
• Patients with an IPSS1 Score of >15 points.
• Maximum urinary flow rate (Qmax) ≤15 mL/sec.
• Post void residual volume (PVR) ≤300 mL.
• Prostatic volume >50g by TRUS.

Exclusion Criteria:

• Patients with any previous minimally invasive or surgical intervention for BPH.
• Patients who have enrolled in, or are currently enrolled in, another clinical trial for any disease within the past 30 days.
• Patients with an active urinary tract infection.
• Patients with a urethral stricture.
• Patients with a predominant middle lobe obstruction.
• Patients who have evidence or history of prostate or bladder cancer.
• Patients with a PSA of >10 ng/ml. If the PSA is 4-10 ng/ml, preliminary biopsy should be done within one-year of entry to rule out prostate cancer.
• Patients who had a biopsy of the prostate within the past 6 weeks.
• Patients with bleeding diathesis.
• Patients with clinically significant renal or hepatic impairment.
• Patients with neurological conditions felt to affect the bladder or a history of a neurogenic or chronically decompensated bladder.
• Patients who daily use a pad or device for incontinence.
• Patients who had an episode of unstable angina pectoris, myocardial infarction, transient ischemic attack, or cerebrovascular accident (stroke) within the past 6 months, or peripheral arterial disease with intermittent claudication or Leriches syndrome.
• Patient has an interest in future fertility.
• Patients with prolonged QT interval at baseline and currently taking medications that prolong QT interval.
• Inadequate organ function as evidenced by the following: Platelet count <100,000/mm³; WBC <4,000/mm³; Neutrophils <1,800/mm³; Hemoglobin <10 g/dL; SGOT and SGPT >3 x ULN; Creatinine >1.2 mg/dL
• Known sensitivity to porphyrin-type drugs or known history of porphyria.
• Inability to avoid sunlight after procedure during the first 2 weeks after LS11 administration.