Alpha DaRT Applicators. Photo: Screenshot.

JNS.org – An Israeli medical technology company that developed a breakthrough in radiation cancer therapy announced on Wednesday it would begin clinical trials with leading medical institutions in Italy with the target of receiving approval from the European Commission by next year.

The startup, Alpha Tau Medical, was founded in 2016 to specialize on research and development, and commercialization of the treatment called Alpha DaRT (Dіffusіng Alpha-emіtters Radіatіon Therapy), which was first developed in 2003 by Tel Aviv University professors Itzhak Kelson and Yona Keisari to deliver “high-precision alpha radiation that is released when radioactive substances decay inside the tumor, killing cancer cells while sparing the surrounding healthy tissue,” according to the breakthrough innovation news site NoCamels.

Early results from an ongoing pre-clinical trial at Rabin Medical Center in Israel and the IRST (Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori) in Italy on clients with squamous cell carcinoma (SCC) tumors revealed a reduction in all tumor sizes, and more than 70 percent of tumors disappearing altogether within a few weeks post-treatment.

The clinical trials will occur at the Sapienza University of Rome, which is launching Alpha Tau’s clinical trial protocol for SCC of the oral cavity and skin, alongside the IFO (Istituti Fisioterapici Ospitalieri), which is undergoing its first study of Alpha DaRT for treatment of mucosal malignant neoplasia and cutaneous.

“The participation in Alpha Tau’s SCC protocol is a great clinical and scientific opportunity,” said Vincenzo Tombolini, a radiation oncologist at Sapienza. “I am proud to be able to offer this revolutionary treatment in the training course of physicians specializing in radiotherapy.”

The technology has been tested on more than 6,000 animals in numerous experiments and has been discovered “to be effective and safe for various indications, including tumors considered to be resistant to standard radiotherapy,” said the startup.