Alpha Tau gets FDA investigational device exemption supplement to IMPACT study

Alpha Tau (DRTS) announced that the FDA has approved an investigational device exemption supplement to its U.S. multi-center pancreatic cancer pilot study, known as IMPACT, 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. The IDE supplement expands the trial to allow ten additional newly diagnosed patients receiving gemcitabine/nab-paclitaxel together with Alpha DaRT, five of whom with unresectable locally advanced pancreatic cancer and five with metastatic pancreatic cancer. Together with the previous IDE approval to recruit 30 patients in this trial for treatment with Alpha DaRT together with mFOLFIRINOX, the IMPACT trial is now expected to recruit a total of 40 patients.