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news.Sophiris Bio has announced that a benign prostatic hyperplasia (BPH) drug, PRX302, was well tolerated using the preferred transrectal route of administration through three months in its transrectal safety study.
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The results support the use of a transrectal ultrasound guided injection for the delivery of PRX302 directly into the prostate, which are useful in future clinical trials of PRX302 in BPH patients.
Sophiris Bio CEO Randall Woods said that the decision to move to a transrectal route of delivering PRX302 directly into the prostate as opposed to transperineal was made based on the input of advisors and leading urologists treating patients with BPH.
"The transrectal route enables PRX302 to be administered by a urologist in an office based setting, in a brief procedure that does not require catheterization," Woods added.
"To date 126 patients with BPH have been treated with PRX302 with a similar safety and tolerability profile between the transrectal and transperineal routes of administration."
The ongoing Phase 1-2 study demonstrated that all four cohorts through month 3 indicate that PRX302 continues to be well tolerated with a similar adverse event profile that seen in previous clinical studies using a transperineal injection.
The multicentre study also observed the improvement in the International Prostate Symptom Score in all cohorts.