10:14 AM EDT, 09/20/2024 (MT Newswires) -- Alpha Tau Medical ( DRTS ) said Friday that the US Food and Drug Administration approved its investigational device exemption application to start a multi-center study on Alpha DaRT as a treatment for recurrent cutaneous squamous cell carcinoma in immunocompromised patients.
The company said the approved study design allows for the enrollment of up to 28 patients in the US at up to eight institutions.
The study's primary endpoint is the objective response rate to the treatment and secondary endpoints include progression-free survival and overall survival, among others, Alpha Tau Medical ( DRTS ) added.
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