Sophiris Bio provides update on patient death in prostate cancer trial
Sophiris Bio announced the conclusion of the ongoing investigation into the previously reported death of a patient in the Company's Phase 2b trial for the treatment of localized prostate cancer is unlikely to be related to either topsalysin or the procedure. The regulatory authorities in the U.S. and the U.K. where the study is being conducted have been notified. Following a comprehensive review of the recently received autopsy report, together with hospital records and the negative serology results for acute hypersensitivity, the Investigator and company believe that the cause of death is consistent with the autopsy finding of Sudden Cardiac Death probably due to an arrhythmia. The autopsy found that the patient had multiple risk factors for SCD. The investigator and the company concur that the event is unlikely related to topsalysin or the procedure.