The Massachusetts Radiation Control Program (RCP), in conjunction with the U.S. Nuclear Regulatory Commission (NRC), has approved Alpha Tau Medical’s Alpha DaRT cancer treatment as a Sealed Source and Device (SSD).
Granting of the certification deems the brachytherapy solution a suitable candidate for clinical trials at U.S. cancer centers in the treatment of various types of solid tumors. Known as Diffusing Alpha-emitters Radiation Therapy, the approach is the first alpha radiation-based cancer treatment for various types of solid tumors.
“The Alpha DaRT applicators are designed to ensure that the Alpha DaRT Seeds and the radioactive isotopes will be released only inside of the tumor in a way that will eliminate the risk of unnecessary exposure to the patient or the medical staff,” Amnon Gat, chief operations officer for Alpha Tau Medical, told HCB News. “The sealing mechanisms of the Alpha DaRT devices were tested under extreme environmental conditions that are required by ISO 2919, such as high temperature, pressure, impact and bending."
Developed by Professor Yona Keisari from the faculty of medicine and Professor Itzhak Kelson from the physics department at Tel Aviv University, Alpha DaRT administers high-precision, soft-range alpha particles that effectively destroy cancer cells while sparing surrounding healthy tissue.
The particles are inserted into the tumor using ultra-minimally-invasive applicators designed by the Israeli MedTech startup for various types of tumor within different anatomic areas. Upon the decay of radioactive substances inside the tumor, the alpha radiation is released, creating complex double-strand DNA breaks that destroy the cancer cells.
The approach overcomes the short range limits that have made Alpha therapy unsuitable in treating cancer, and is backed by preliminary clinical trials that deemed Alpha DaRT a safe and effective treatment for squamous cell carcinoma tumors. All patients tested experienced a reduction in the size of their tumors, more than 70 percent of which disappeared within days following treatment.
The solution will next be assessed in clinical trials using different protocols across a range of indications, including pancreatic cancer, breast cancer, head and neck cancer, gynecological cancer and prostate cancer.
If successful, access to Alpha DaRT could come soon, says Gat, providing patients with immediate access to cancer treatment.
“The regulatory pathway is dependent upon the results of the clinical studies,” he said. “Unfortunately, many patients do not benefit from existing treatments and therefore the company hopes that good clinical results will shorten the time to market and will allow patients to enjoy the benefits of the treatment as soon as possible.”
Expecting high demand for Alpha DaRT, Alpha Tau Medical is currently establishing a new production facility in the U.S. with Gat appointed to head its operations.