Trial observers say ‘game over’ for XBiotech's failed PhIII cancer study, the latest in a long line of setbacks
There’s more bad news to report for XBiotech $XBIT.
A few weeks after European regulators snubbed the company’s application to start marketing its dubious cancer drug Xilonix, the Austin-based biotech is back with the news that it’s halting a Phase III colon cancer study after outside experts concluded it wasn’t working.
The IDMC had no safety concerns from the unblinded analysis. However, the committee recommended the early termination of the study since the findings were not sufficient to meet efficacy or the threshold for continuation, which involved a prospectively defined acceptance boundary for the interim analysis of less than or equal to p = 0.08.
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