Israeli medtech company Alpha Tau Medical announced positive results of a clinical trial involving its breakthrough alpha radiation cancer treatment method Alpha DaRT (Dіffusіng Alpha-emіtters Radіatіon Therapy.)
The first clinical trial of the novel treatment, which was published in the International Journal of Radiation Oncology, Biology, and Physics, the official journal of the American Society for Radiation Oncology, showed nearly 78.6 percent of 28 patients received a complete tumor response rate. That means the patients all responded to the alpha radiation treatment in some way.
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This is quite noteworthy “given that over 40 percent of the patients had undergone prior radiation therapy to the affected area and 61 percent of patients overall had received some form of prior therapy,” the company said in a statement.
There were no systematic toxicities noted, the company said, and any side effects resolved themselves within three to five weeks.
Founded in 2016, Alpha Tau Medical Ltd. focuses on R&D and commercialization of its Alpha DaRT treatment. The technology was initially developed in 2003 by Professors Itzhak Kelson and Yona Keisari at Tel Aviv University and delivers high-precision alpha radiation that is released when radioactive substances decay inside the tumor, killing cancer cells while sparing the surrounding healthy tissue.
The first clinical trial was conducted in Israel and Italy. It was designed to establish the safety, feasibility, and efficacy of the company’s Alpha DaRT technology for patients with squamous cell carcinoma of the skin and head and neck area. Alpha DaRT seeds were placed on 31 lesions in 28 patients.
“The results we obtained from our first clinical trial in human squamous cell carcinoma patients confirm the promising findings from preclinical studies. The observed tumor response rates and survival metrics seem especially impressive given this elderly (median age 80.5 years) and heavily pretreated patient sample. Overall, these impressive outcomes serve as an excellent basis for future trials in other tumor types,” said the principal investigator of the trial Prof. Aron Popovtzer, MD, from Rabin Medical Center in Israel. The Italian arm of the trial was led by Dr. Salvatore Roberto Bellia from the IRST (Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori).
Future clinical trials will also investigate Alpha DaRT in other oncology indications, as a monotherapy or in combination with various systemic therapies, the company said.