Saturday, May 7, 2016 10:30 AM-11:30 AM
Late-Breaking Science & Technology Poster
Funding: Sophiris Bio Corp
LB-S&T-04: Prospective, Randomized, Double Blind, Vehicle Controlled, Multinational, Phase 3 Clinical Trial of the Pore Forming Protein PRX302 for Targeted Treatment of Symptomatic Benign Prostatic Hyperplasia
Claus Roehrborn*, Dallas, TX, Reginald Bruskewitz, Madison, WI, Richard Yocum, Allison Hulme, La Jolla, CA, Marc Gittelman, Aventura, FL
Introduction and Objectives
Patients with lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH) desire treatment options besides medications, which have side effects and lack of sustainability, and more invasive surgical interventions, which also have side effects and complications. PRX302 (topsalysin) is a genetically modified pore-forming protein (aerolysin) activated intraprostatically only by enzymatically active PSA, and thus a specific, highly-targeted, localized approach to lysing cells in the prostate transition zone.
479 patients from 75 sites in 6 countries with International Prostate Symptom Score (IPSS) =15, peak urine flow (Qmax) 5-15 mL/s, and prostate volume (PV) 30-100 mL were randomized 1:1 to a single transrectal intraprostatic injection of PRX302 vs. placebo (vehicle) and then monitored for 52 weeks. BPH medications were washed out and prohibited on study. Injection was 20% of PV and 0.6 ug PRX302/g PV.
92% of patients completed all 52 weeks. A single administration of PRX302 provided 7.6 points mean improvement in LUTS that was statistically significantly superior to vehicle-only injection, sustained through the Week 52 end of monitoring. This IPSS primary endpoint efficacy was supported by secondary endpoints, including positive findings for Qmax and two patient-rated disease-specific quality of life instruments. Relative to vehicle, PRX302-apparent toxicity was in general mild, transient, limited to irritative urinary
Did not like the top action today. The strength of the sellers into the 1.47 - 1.53 runup was too strong given the overall volume. ARNA has made a similar move and NT all in all bought 1mm shares for 1.2mm dollars this could just have been a window dress average price to balance the portfolio - they had already owned 12.5 mm
may be wrong - usually am :( but next week we will see how much I left on the table