Patient Enrollment Complete for DaRT Clinical Trial in Japan

By News Release


Alpha Tau Medical Ltd. and its clinical trial partner in Japan, HekaBio K.K., have completed recruitment in its open-label multi-center pivotal study evaluating the Alpha DaRT in Japanese patients with recurrent Head & Neck cancer after radiotherapy.

HekaBio has reported that preliminary results of this trial are highly encouraging, and that it will continue compilation and analysis of the data in collaboration with its medical experts, in an effort to prepare a submission seeking marketing approval via the shonin pathway in consultation with Japanese authorities. No results of the clinical trial are expected to be published until submission to the Japanese authorities.

Alpha Tau CEO Uzi Sofer remarked, "This is an important milestone for Alpha Tau, as we look to bring our unique Alpha DaRT therapy to patients around the world. Having secured our first marketing authorization in Israel, we look forward to seeing pivotal trial data from Japan, with an eye toward initiating a pivotal trial in the U.S. in 2022. Japan is an important market for Alpha Tau, and we appreciate the untiring efforts of HekaBio CEO Rob Claar and his team, as well as all of the investigators from leading cancer centers in Japan who have participated in this trial."

Alpha DaRT (Diffusing Alpha-emitters Radiation Therapy) is designed to enable highly potent and conformal alpha-irradiation of solid tumors by intratumoral delivery of radium-224 impregnated sources. When the radium decays, its short-lived daughters are released from the source and disperse while emitting high-energy alpha particles with the goal of destroying the tumor. Since the alpha-emitting atoms diffuse only a short distance, Alpha DaRT aims to mainly affect the tumor, and to spare the healthy tissue around it.