Targeted radiation therapy is quickly becoming a preferred procedure for cancer treatment as it limits radiation exposure to surrounding tissue. Image Credit: ArtemisDiana / Shutterstock.

Alpha Tau Medical has unveiled clinical development plans for its Alpha DaRT radiotherapy device during the second quarter (Q2) financial results.

The company aims to complete recruitment for three trials evaluating Alpha DaRT as a treatment for liver metastasis, cutaneous squamous cell carcinoma, and lung cancer. Alpha Tau also plans to trial the device in patients with brain cancer, with the study expected to start by the end of the year.

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The Israeli company is also planning to expand its manufacturing capabilities and has started renovations for a new manufacturing plant in Hudson, New Hampshire, US. Alpha Tau also reported cash reserves of $74.1m as of 30 June 2024, which is expected to fund operations for at least two years.

Alpha DaRT emits diffusing radiation therapy through Alpha-emitters. The device irradiates solid tumours by intratumoral delivery of radium-224-impregnated sources. The radium then decays, it produces short-lived particles that disperse and emit high-energy alpha particles. These alpha-emitting atoms only diffuse a short distance and mainly affect the tumour, sparing healthy tissue.

Targeted radiation therapy is quickly becoming a preferred procedure for cancer treatment as it limits radiation exposure to surrounding tissue. Multiple companies are developing targeted cancer devices. GT Medical Technologies has developed a Cesium-131 brachytherapy, a radiation treatment where tiny radioactive seeds are implanted directly into or adjacent to a tumour.

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The safety and feasibility trial (NCT05829291) plans to enrol up to ten patients who are eligible for a two-staged hepatectomy to resect liver metastases of colorectal cancer. In May 2024, the first patient in the study was treated with Alpha DaRT.

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Alpha Tau plans to complete recruitment in the ReSTART pivotal trial (NCT05323253) by the end of this year. The study evaluates Alpha Tau in patients with recurrent cutaneous squamous cell carcinoma. The company said it will also start treating patients in the Israeli recurrent lung cancer safety and feasibility trial (NCT05632913).

Alpha Tauis expecting a response from Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) for Alpha DaRT’s pre-market approval in patients with recurrent head and neck cancer. The data from the two trials evaluating Alpha DaRT’s use in patients with advanced inoperable pancreatic cancer (NCT04002479 and NCT05657743) is expected in Q1 2025.