Drug Development, Setbacks

Sophiris says it’s ready to get back on track with lead drug after patient death — but questions linger

Sophiris’ shares $SPHS took a beating two months ago when the biotech disclosed that a patient died on the same day of a second administration of their drug topsalysin in a Phase IIb prostate cancer trial.

That death caused the biotech to put a brake on their dosing plans. Now, they’d like to wipe the slate clean of any nagging safety issues.

Randall Woods

In a new statement out this morning, the San Diego-based biotech says the researchers involved have concluded that their patient had likely died as a result of “sudden cardiac death probably due to an arrhythmia…The investigator and the company concur that the event is unlikely related to topsalysin or the procedure.”

Their stock quickly jumped more than 27% on the news.

I asked the company some followup questions to the statement they sent out Wednesday morning. First, there’s no sign that the company plans to go ahead with the two other planned second rounds for their drug. What’s happening on that score? And was the move to suspend dosing completely voluntary? If it was, why not just announce you were returning to complete the dosing?

In an email response from CFO Peter Slover, Sophiris responded that they won’t finish the second round of dosing as “there were only two patients that would have been eligible for a second treatment.” And Slover emphasized that the study halt was entirely voluntary, with investigators reporting the incident to regulators.

“We continue to plan and move forward with a potential Phase 3 study design based on the response rates and safety profile we have observed to date,” said CEO Randall Woods in a statement. “We look forward to reporting the complete efficacy and safety data from the Phase 2b study by the end of the year which will include the biopsy and safety data from the 10 patients who received a second administration of topsalysin.” 


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