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Alpha Tau Expands Alpha Dart Trial Following FDA Approval of IDE Supplement

-- Alpha Tau Medical (DRTS) said Thursday that the US Food and Drug Administration has approved an Investigational Device Exemption, or IDE, supplement for its pancreatic cancer study.

The IDE supplement expands the Impact pancreatic cancer trial to allow ten additional newly diagnosed patients receiving gemcitabine/nab-paclitaxel together with Alpha DaRT, taking the total number of recruits for the study to 40 patients, the company said.

The Impact study is evaluating the safety, feasibility, and efficacy of Alpha DaRT, in combination with chemotherapy for patients with newly diagnosed unresectable locally advanced or metastatic pancreatic adenocarcinoma, Alpha Tau Medical said.

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