Therapeutic activity of PRX302 was assessed using standardized symptom indices, namely, International Prostate Symptom Score (IPSS) and Quality of Life Scores (QoL). IPSS assesses the severity of seven key symptoms of benign prostatic hyperplasia (BPH) (incomplete emptying, frequency, intermittency, urgency, weak stream, straining and nocturia).
At six months post-treatment the mean IPSS values improved by an average of 6.4 points from 19.1 +/- 4.3 at screening to 12.7 +/- 5.2 at day-180 post treatment (p= 0.0009), with six of 15 patients showing a 10 point or greater improvement in IPSS values. In the six men for whom nine-month data are available at this time, IPSS values improved by an average of 6.1 points. QoL scores improved by two points from an average of 4.5 +/- 1.1 at screening to 2.5 +/- 1.4 by day-180 (p= 0.0002).
In the six men for whom nine-month data is available, QoL scores improved by an average of 2.3 points by day-270. The mean prostate volume decreased by over 22%, from 46.4 cc at screening to 35.8 cc at day-180 post-treatment and by 20% from 49.6 cc at screening to 39.7 cc at day-270 post-treatment.
Based on the encouraging data from this study, Protox has initiated a Phase II clinical trial in men with moderate to severe BPH. The intent of this Phase II study will be to optimize dosing in order to fully exploit the therapeutic potential of PRX302, while maintaining its excellent safety profile.