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

 
• By Joseph Haas

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.

Cancer cells

Sophiris Bio Inc. will forge ahead with plans for a Phase III study of its prostate cancer candidate topsalysin despite final data from a Phase IIb study showing that a second administration of the drug did not provide a clinical benefit in patients who were partial responders to a first dose. The San Diego biotech hopes to meet with US and EU regulators in early 2019 to draw up a Phase III study based on one-time administration of the drug, execs said during an investor call Dec. 17.

Sophiris’ stock finished the trading day down 40%, to $1.23 per share, the latest swing in an up-and-down 2018 for...

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