AlphaTau Medical, a Nasdaq-listed company specializing in tumor treatments, is broadening the scope of its multi-center pilot clinical trial (IMPACT) for pancreatic cancer patients in the U.S.
The company announced on Thursday that it recently received approval from the U.S. Food and Drug Administration (FDA) for a supplemental Investigational Device Exemption (IDE) for its clinical trial.
This supplemental approval allows AlphaTau to recruit additional patient groups for a combination treatment involving gemcitabine and nab-paclitaxel, a standard first-line chemotherapy regimen for pancreatic cancer, expanding beyond the existing clinical scope.
The clinical expansion will include 10 more patients: five newly diagnosed with unresectable locally advanced pancreatic cancer and five with metastatic pancreatic cancer. This addition, combined with the 30 patients in the existing standard chemotherapy (four-drug regimen/mFOLFIRINOX) group, brings the total IMPACT trial enrollment to 40 patients.
AlphaTau’s Chief Executive Officer (CEO), Uzi Sofer, described the FDA approval as a significant step forward in the company’s core mission to develop new treatments for this life-threatening disease.
Established in 2016, AlphaTau is an Israeli oncology therapeutics firm focused on researching, developing, and potentially commercializing Diffusing Alpha-Emitters Radiation Therapy (AlphaDaRT) for solid tumor treatment.
The AlphaDaRT technology was developed by Professors Itzhak Kelson and Yona Keisari from Tel Aviv University.
AlphaDaRT is engineered to deliver highly potent and precise alpha irradiation to solid tumors through the intratumoral placement of a radium-224 impregnated source.
As radium decays, it releases short-lived daughter nuclides that disperse, emitting high-energy alpha particles intended to destroy the tumor.
Due to the limited range of alpha-emitting particles, AlphaDaRT primarily targets the tumor while sparing the surrounding healthy tissue.