Alpha Tau Medical (DRTS) said Thursday the US Food and Drug Administration has cleared the enrollment of seven more patients and addition of two US clinical sites for its Alpha DaRT trial in recurrent glioblastoma.
The regulator issued the clearance after reviewing interim safety data from the first three patients treated in the study, the company said, adding it intends to immediately proceed with the enrollment of the final seven participants for the study.
The company said in May that interim results from three patients showed 100% local disease control, including a 67% complete response rate with no unexpected safety signals.
Shares of Alpha Tau Medical were up 2% in premarket activity Thursday.
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