Sophiris Bio has concluded enrolling patients in a Phase llb study that will evaluate the safety and tolerability of targeted intraprostatic administration of topsalysin to treat men with clinically significant localised prostate cancer.
The multi-centre, open-label, clinical trial employs previously obtained MRI images of each patient’s prostate co-registered to real-time 3D ultrasound to deliver topsalysin directly into and around a pre-identified clinically significant tumour.
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Biopsy data from all patients dosed with the first administration of topsalysin is expected to be available by the first half of next year.
Topsalysin (PRX302) is a new transmembrane pore-forming protein genetically updated to be activated only in the presence of enzymatically-activeprostate-specific antigen (PSA), which is found only within the prostate.
The Phase llb study investigator and Imperial College London & Imperial College Healthcare NHS Trust Urology chair Hashim Ahmed said: “Over the next few months, men in the trial will undergo follow-up biopsies of the prostate and, if necessary, may undergo repeat topsalysin dosing.”
The study also features an option to re-treat patients with a second dose of topsalysin, with an additional targeted biopsy to occur six months following the second dose.
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By GlobalDataFor taking part in the second dose, the patient cannot have experienced a clinically significant adverse event attributable to topsalysin or the dosing procedure from the first dose.
The patient will also require to have had a clinical response from the first dose but still have the presence of a clinically significant lesion area, while the patients who have a complete response to the first dose will not receive a second dose.
