Alpha Tau announces FDA approval of IDE to initiate study of Alpha DaRT

Alpha Tau Medical announced that the U.S. Food and Drug Administration, FDA, has approved an Investigational Device Exemption, IDE, application to initiate a multi-center study for the treatment of recurrent cutaneous Squamous Cell Carcinoma, cSCC, in immunocompromised patients using the Alpha DaRT. The clinical study, which is an investigator-initiated study led by the Winship Cancer Institute of Emory University in Atlanta, has been approved to enroll up to 28 U.S. patients at up to 8 institutions in the U.S., and will focus on patients with recurrent cSCC who have a weakened immune system due to any primary or secondary immunodeficiencies, excluding diabetes. The primary efficacy objective of the study is the objective response rate to the treatment, as measured by best overall response. Secondary efficacy objectives include progression-free survival, overall survival and local control up to twelve months after treatment, and the safety objective is the measurement of any related adverse events.