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 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 (3(micro)g/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 and prostate shrinkage at three months following a single treatment with PRX302.
Fahar Merchant, president and CEO of Protox, said: “We believe that PRX302 has the potential of establishing a new standard of care for a disease that affects millions of men worldwide.”