Alpha Tau Announces Health Canada Authorization for Alpha DaRT Clinical Trial for the Treatment of Liver Metastases

Thursday, March 02, 2023

Alpha Tau Medical Ltd., the developer of the innovative alpha-radiation cancer therapy Alpha DaRT™, announced today that it has received authorization from Health Canada to proceed with a feasibility and safety study of Alpha DaRT in the treatment of liver metastases, subject to final approval by an institutional Research Ethics Board, which the Company expects to receive in the coming weeks. The study is planned to be conducted at the McGill University Health Center in Montreal, Canada.

The trial will seek to recruit 10 patients who are eligible for a two-staged hepatectomy to resect liver metastases of colorectal cancer. Specifically, in the first stage, as many metastatic tumors as possible will be surgically removed in a non-curative intervention while Alpha DaRT sources will be inserted into a separate tumor, and in the second stage, after allowing for the resected liver to regenerate naturally, the portion of the liver with the Alpha DaRT sources will be surgically removed.

The study primarily aims to examine the feasibility of delivering Alpha DaRT sources into the liver metastases, as well as the safety of utilizing the Alpha DaRT sources in the liver by assessing the frequency and severity of related adverse events. The study will also examine Alpha DaRT’s efficacy in terms of radiological response, assessed after insertion of the Alpha DaRT sources, and via pathological response assessed after the second stage of surgery.

Alpha Tau CEO Uzi Sofer commented, “The authorization by Health Canada for this study to proceed represents an important milestone for the Company. This trial examining the use of Alpha DaRT in liver metastases for the first time signifies a big step forward in our overall strategy to broaden the use of the Alpha DaRT in hard-to-treat indications, including other cancers such as those of the brain, lung, pancreas, vulva and breast.”



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