The activities associated with patient screening have commenced and the company expects to enroll the first patient during the second quarter of 2008. The goal 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.
In this study up to 30 patients with moderate to severe benign prostatic hyperplasia (BPH) will receive a volume of PRX302 dosing solution equivalent to 10, 20 or 30% of the total prostate volume. A fixed concentration of PRX302 (3microgram/ml) will be delivered in three distinct deposition points along the urethra through a single ultrasound-guided transperineal injection into each lobe of the prostate. Therapeutic activity will be assessed based on symptomatic relief, prostate shrinkage and uroflow measurements at three months following a single treatment with PRX302.
Fahar Merchant, president and CEO of Protox, said: “This is a significant milestone for the company and we look forward to building upon the very promising results that we released from the Phase I BPH study early 2008.”