Phase 3 Trial of Topsalysin, Potential Treatment for Localized Prostate Cancer, Planned for Europe

Phase 3 Trial of Topsalysin, Potential Treatment for Localized Prostate Cancer,  Planned for Europe
The European Medicines Agency (EMA) has approved Sophiris Bio’s design for a Phase 3 trial to evaluate the potential of topsalysin (PRX302), an investigative agent for localized prostate cancer. The trial plans to enroll 700 men with intermediate risk disease, who will be randomized to either a single injection of topsalysin or a placebo. Its main goal is to determine the proportion of patients who fail to respond to the treatment within the first year of receiving it, as defined by evidence disease progression and a need for additional treatments. Results from the Phase 3 trial, if successful, will be used to support a request for topsalysin's approval in Europe, Sophiris said. Topsalysin is an engineered protein that forms small pores in cells, causing their contents to leak, which ultimately leads to their death. To prevent damage to healthy cells, the protein only becomes active in the presence of active prostate-specific antigen (PSA), a protein that is produced in excess by prostate cancer cells. Topsalysin can be delivered directly into the prostate tumor, reducing the risk of damage to neighboring cells and tissues in patients with localized prostate cancer and with a low risk for cancer spreading. In this way, it is designed to avoid many side effects of more radical therapies, including surgery to remove the entire prostate and radiotherapy, which can lead to erectile dysfunction, urinary incontinence, and rectal toxicity. Previous Phase 1 (NCT00379561) and Phase 2 (
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