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Patient Death Obscures Efficacy Success For Sophiris’ Intratumoral Prostate Cancer Therapy

Executive Summary

The bad outweighed the good for Sophiris on a day in which it unveiled promising Phase IIb data for topsalysin, but also took a huge stock hit with news of a patient death in the trial.

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Sophiris Will Start Phase III For Topsalysin In Prostate Cancer Despite Mixed Data Package

Emphasizing solid results for the first administration of topsalysin in patients with localized prostate cancer, the firm is sticking with Phase III plans for one dose despite final Phase IIb data showing no clinical benefit from a second dose. Sophiris’ share price tumbled on the news.

Dark Cloud Lifts On Sophiris Bio's Localized Prostate Cancer Injectable Topsalysin

Phase IIb study death after intratumoral injection was unrelated to study drug, San Diego-based start-up says.

Sophiris Targets Prostate Cancer With Modified Biologic

Nearly 140,000 men each year are diagnosed with localized prostate cancer, and the common treatment is radical - surgical removal of the prostate or whole organ radiation. Sophiris Bio is a San Diego-based biotech developing topsalysin for the focal treatment of localized prostate cancer, and may spare the organ from such massive collateral damage. Speaking at the Biotech Showcase, Sophiris CEO Randall Woods explained to Scrip how topsalysin works and how he is looking to continue clinical development of the biologic, in both localized prostate cancer and benign prostatic hyperplasia.

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