Sophiris eyes phase 3 after clearing patient death from its lead study

Sophiris Bio has completed its investigation into the death of a patient that halted additional dosing in a trial of its lead candidate topsalysin two months ago, finding its procedure for localized prostate cancer was unlikely to be the cause. Sophiris’ stock was up 30% on the news, after dropping precipitously in June. The company said it has notified regulatory authorities in the U.S. and the U.K., where the open-label phase 2b study is being conducted. Topsalysin, a transmembrane, pore-forming protein, was genetically modified to be activated only by enzymatically active prostate-specific antigen, with the goal of eroding localized prostate cancer lesions while avoiding complications.