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 the company and its mid-stage candidate for localized prostate cancer
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