Alpha Tau Medical can begin U.S. clinical trials of its cancer-zapping device, thanks to a new permit from the Massachusetts Radiation Control Program.
The state agency granted a Sealed Source and Device (SSD) approval to the Tel Aviv company’s Alpha DaRT (Dіffusіng Alpha-emіtters Radіatіon Therapy), which enables alpha-radiation-based cancer treatment for various types of solid tumors.
Alpha DaRT delivers high-precision alpha radiation that is released when radioactive substances decay inside the tumor, according to the company. The short-range alpha particles effectively kill the cancer cells while sparing the surrounding healthy tissue. Preliminary clinical results showed that Alpha DaRT is safe and effective for treating squamous cell carcinoma tumors, with all patients’ tumor sizes reducing and more than 70% of patients’ tumors completely disappearing within few days after treatment, the company said.
The treatment is delivered by intratumoral insertion of the Alpha DaRT seed that contains Radium-224 atoms embedded below its surface. In the process of decay, Radium-224 releases its short-lived Alpha-emitting atoms into the tumor. By diffusion and convection, these atoms disperse to a therapeutically significant range of several millimeters, delivering a high dose of radiation inside the tumor.
“With promising early clinical results demonstrated in Europe and Israel, we are delighted to achieve this final milestone SSD approval, and to enable hospitals throughout the U.S. to benefit from the Alpha DaRT treatment in their clinical trials,” said Alpha Tau CEO Uzi Sofer in the statement.
The trials will investigate Alpha DaRT using different protocols across a variety of indications, including pancreatic, breast, head and neck and gynecological cancers.
“The high potency and targeted activity of alpha radiation to kill cancer cells has been known for some time in the medical community,” John Munro III of the Alpha Tau radiation safety office said in the statement. “The SSD certificate confirms the safety of the innovative Alpha DaRT technology and gives the go-ahead for hospitals throughout the U.S. to investigate its treatment benefit for solid tumors.”
The company is also establishing a new production facility in Lawrence, Mass., headed by its chief operations officer, Amnon Gat.