- Alpha DaRT pancreatic cancer patient treatments underway in U.S. multi-center pilot study - - Newly received radioactive material license for New Hampshire facility positions the Company for continued advancement towards commercial readiness - - Multiple meaningful milestones targeted in the coming months, including completion of patient recruitment in the U.S. pivotal ReSTART trial - - Cash, cash equivalents & deposits balance of $75.9 million provides runway for continued clinical advancement and commer ...

Core Insights - Alpha Tau Medical Ltd. has initiated a multi-center pilot study in the U.S. for its Alpha DaRT® therapy targeting pancreatic cancer, marking a significant step in addressing the urgent need for innovative treatments in this area [1][4][10] Industry Overview - Pancreatic cancer is the third leading cause of cancer-related deaths in the U.S., with approximately 66,000 new cases diagnosed annually, and up to 87% of these patients are considered inoperable at diagnosis [3][4] - The prognosis for these patients is poor, with limited benefits from existing therapies, highlighting the critical need for new treatment options [3][4] Company Strategy - The pilot study, known as IMPACT, aims to evaluate the safety, feasibility, and efficacy of Alpha DaRT in combination with chemotherapy for patients with newly diagnosed unresectable locally advanced or metastatic pancreatic adenocarcinoma [1][6] - This study is part of Alpha Tau's broader strategy to provide Alpha DaRT to cancer patients with significant unmet needs [1][4] Study Details - The IMPACT study plans to enroll up to 30 patients, with 15 having inoperable locally advanced disease and 15 with metastatic disease, across multiple centers in the U.S., Canada, and Israel [6][7] - Eligible patients must have newly diagnosed, histologically confirmed pancreatic adenocarcinoma and must be inoperable, non-irradiated, and either chemotherapy-naïve or within the first four cycles of their initial chemotherapy regimen [7] Treatment Methodology - Patients will continue receiving standard-of-care chemotherapy (mFOLFIRINOX) while Alpha DaRT sources will be implanted into the primary tumor using ultrasound-guided endoscopy [8][9] - The primary objectives of the study include assessing the feasibility of Alpha DaRT source implantation and evaluating its safety and tolerability, with secondary objectives focusing on local tumor response and overall survival [9]