The company is developing PRX302 (topsalysin) for the treatment of urological diseases.
Around 20 patients will be enrolled in this trial, in which previously secured multi-parametric magnetic resonance imaging (mpMRI) of tumor lesions in each patient’s prostate, mapped to real-time three-dimensional transrectal ultrasound (TRUS) will be used to guide the injection of PRX302 to treat a single, histological-proven, clinically significant lesion area in each patient’s prostate.
Sophiris CEO and R&D head Allison Hulme said: "PRX302 is a novel targeted approach for the treatment of clinically significant, localized prostate cancer that is still confined within the prostate gland.
"PRX302 has been engineered to be activated only by enzymatically active prostate specific antigen (PSA) which is present only in prostate tissue, including the transition zone of the prostate as well as prostate cancer cells.
"PRX302 can be focally delivered by an intraprostatic injection directly into and around the tumors within the prostate where there are high levels of enzymatically active PSA to activate the drug."
The trial’s primary objective is safety and tolerability, while the key efficacy variable is the change in the treated clinically significant lesion on biopsy after six months.