Patient Death in Phase 2b Prostate Cancer Trial Unrelated to Topsalysin, Sophiris Says

Patient Death in Phase 2b Prostate Cancer Trial Unrelated to Topsalysin, Sophiris Says
Topsalysin (PRX302), an investigative agent for localized prostate cancer, is unlikely to have caused the death of a patient in a Phase 2b trial testing the medicine, Sophiris Bio announced. A review of clinical records and information from the autopsy point to a sudden cardiac event caused by an arrhythmia as the most likely cause of death; the patient had multiple risk factors for the condition. Bloodwork also excluded an acute hypersensitivity to the drug. The patient died after a second administration of topsalysin in a Phase 2b trial (NCT03081481). As a precaution, no additional patients received a second administration. Regulatory agencies in the United States and the United Kingdom, where the study is being conducted, have been notified of the findings and are expected to support the study's continuation. "Topsalysin continues to appear to be well-tolerated with no new safety signals reported," Randall E. Woods, president and CEO of Sophiris, said in a press release. “We look forward to reporting the complete efficacy and safety data from the Phase 2b study by the end of the year, which will include the biopsy and safety data from the 10 patients who received a second administration of topsalysin." Topsalysin is an engineered protein that forms small pores in cells, causing their contents to leak and leading to their death. To prevent damage to healthy cells, the protein is made t
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