Israeli radiation therapy technology developer Alpha Tau Medical said that its Alpha Diffusing Alpha-Emitters Radiation Therapy (DaRT) system has received the necessary regulatory approvals to be used in clinical trials at U.S. cancer centers.
Alpha DaRT has been approved as a sealed source and device by the Massachusetts Radiation Control Program (RCP), under agreement with the U.S. Nuclear Regulatory Commission, Alpha Tau said. Designed for the treatment of solid tumors, Alpha DaRT delivers alpha radiation that is released when radioactive substances decay inside the tumor. The short-range alpha particles kill the cancer cells while sparing surrounding healthy tissue, according to the company.
In preliminary testing, Alpha DaRT was shown to be safe and effective for treating squamous cell carcinoma tumors; all patients experienced reduced tumor size and more than 70% had their tumors completely disappear within a few days after treatment, the firm said. The technology was developed by Yona Keisari, PhD, and Itzhak Kelson, PhD, of Tel Aviv University.
The U.S. clinical trials will assess the use of Alpha DaRT for treating cancer using different protocols across a variety of indications, including pancreatic, breast, head and neck, gynecological, and prostate cancers. Alpha Tau said it's currently establishing a new production facility in the U.S. to meet the expected demand for Alpha DaRT. The U.S. operation will be led by Chief Operations Officer Amnon Gat.
