Offering a New Option for Head and Neck Cancer Treatment
HekaBio K.K., (Headquarters: Chuo-ku, Tokyo) announces that the innovative solid tumor treatment device ‘Alpha DaRT (Diffusing Alpha Radiation Therapy),’ developed by Alpha Tau Medical Ltd. (Headquarters: Jerusalem, Israel) has received official approval in Japan. HekaBio led the approval process as the Designated Marketing Authorization Holder (DMAH) and will be responsible for launching the product in the Japanese market.
With this approval, Japan becomes the first country in the world outside of Israel to approve Alpha DaRT. The product will be available in Japan for the treatment of unresectable locally advanced or recurrent head and neck cancer, offering a new therapeutic option for cases where conventional treatments have been insufficient.
We would like to express our sincere appreciation to Dr. Jun Itami, who was affiliated with the National Cancer Center Hospital during the clinical trial and is currently serving as Director of the High-Precision Radiation Therapy Center at Shin-Matsudo Central General Hospital, as well as to all healthcare professionals for their valuable contributions throughout the approval process.
Alpha DaRT: Technology, Mechanism of Action and Efficacy
Alpha DaRT involves inserting sources containing Ra-224(1) atoms fixed in a medical grade stainless-steel tube into solid tumors. As Ra-224 decays, daughter nuclides (Rn-220(2), Po-216(3), Pb-212(4), etc.) are distributed within the tumor tissue, releasing alpha particles that destroy the DNA double strands of tumor cells, leading to cell death.
Mechanism of Action:
Uses high-energy alpha particles to selectively destroy tumor cells locally.
Features:
- Alpha particles induce irreversible double-strand DNA breaks, causing necrosis and apoptosis of cancer cells.
- Due to the extremely short range of alpha particles in the body, the treatment is highly localized, minimizing impact on healthy tissue.
- This technology enables drug-free cancer treatment by overcoming alpha particles’ short-range limitation through intratumoral placement of Radium-224 sources.
Comments
Dr. Jun Itami, Director, High-Precision Radiation Therapy Center, Shin-Matsudo Central General Hospital: “Results from this domestic clinical trial show that Alpha DaRT presents strong potential and meaningful progress in treating cancers unresponsive to standard therapies. Demonstrating the effectiveness of intratumoral alpha‑particle therapy—long considered challenging to implement—marks an important clinical milestone and introduces a new treatment option.
The confirmed safety and efficacy support consideration for real‑world clinical use and provide valuable direction for future studies aimed at expanding indications. Offering an additional therapy also carries psychological value for patients and families.
Although further confirmation and long‑term safety evaluation are required, these findings represent a significant step toward broader clinical application.”
Uzi Sofer, CEO, Alpha Tau Medical: “Receiving Shonin approval in Japan is a significant milestone for Alpha Tau and for the Alpha DaRT platform. Japan has granted our first marketing approval outside of Israel, and is a country with deep clinical expertise in head and neck oncology. We are grateful to HekaBio for their leadership during this process, and to the six medical societies in Japan who have continually provided their support for the approval and future launch of Alpha DaRT in Japan. Our immediate focus is on working closely with Japanese clinicians to complete the PMS study and to generate high-quality clinical data in patients with unresectable locally advanced or locally recurrent disease. In parallel we anticipate initiating discussions shortly with the MHLW regarding potential reimbursement approaches for Alpha DaRT in Japan. We believe this approval represents an important first step toward broader clinical evaluation of Alpha DaRT, and look forward to discussing with the PMDA further potential clinical studies in Japan evaluating the use of Alpha DaRT in additional tumor types.”
Robert E. Claar, CEO, HekaBio K.K.: “The Alpha DaRT program has been the primary focus for our team for 7 years, and we’re delighted to reach this Shonin milestone with Alpha Tau Medical for the benefit of patients in Japan. Along the way, we received strong and continuous support from medical professionals, regulators and the government of Japan to enable approval for this breakthrough therapy. An approval in Japan in advance of the US and Europe for a foreign-originated new category medical device is an extremely rare event, and we’re grateful to all of our partners who made this possible. Our team is enthusiastically preparing to launch Alpha DaRT to deliver hope and clinical benefit to patients in Japan.”
