FDA Approves Initiation of a New Trial in Recurrent Glioblastoma

The FDA has approved an application to initiate a pilot study with Alpha DaRT for patients with recurrent glioblastoma, a form of brain cancer.

The United States Food and Drug Administration (FDA) has approved an Investigational Device Exemption application to initiate a pilot study with Alpha DaRT for the treatment of patients with recurrent glioblastoma, a form of brain cancer.

According to a news release from the developer of the innovative alpha-radiation cancer therapy, Alpha DaRT, Alpha Tau Medical Ltd., the clinical trial is expected to enroll up to ten patients in the United States who have glioblastoma and are not amenable for surgical resection and have undergone a prior course of central nervous system radiation. The primary objective of the clinical study is to evaluate the feasibility and safety of the treatment following results from pre-clinical studies, the news release says.

“This is very exciting news for patients suffering from glioblastoma, a highly aggressive form of brain cancer with an extremely poor prognosis and survival rate. In this trial, we will introduce a completely novel approach, which is specifically designed to deliver Alpha DaRT sources into brain tumors that are not amenable to surgery,” Dr. Robert B. Den, Alpha Tau chief medical officer, said in the news release. “According to the National Brain Tumor Society, glioblastoma is one of the most complex, deadly and treatment-resistant cancers, with an estimated average survival rate of only eight months.”

Alpha DaRT — which stands for Diffusing Alpha-emitters Radiation Therapy — is a treatment designed to target solid tumors with effective radiation while protecting nearby healthy tissue. It works by placing tiny sources containing radium-224 directly into the tumor, and as the radium breaks down, it releases short-lived particles. These particles then spread within the tumor and give off high-energy radiation aimed at destroying cancer cells. Because these particles travel only a short distance, the treatment is focused on the tumor itself, minimizing damage to surrounding healthy tissue.

“This Investigational Device Exemption approval follows the FDA’s continued recognition of the huge promise that this technology holds for patients with recurrent glioblastoma; after having already received the FDA’s Breakthrough Device Designation, followed by acceptance into the FDA’s prestigious Total Product Life Cycle Advisory Program to accelerate the Alpha DaRT treatment to market and to the patients with glioblastoma who may stand to benefit greatly,” Alpha Tau CEO, Uzi Sofer, added in the news release.

More on the Current Landscape of Recurrent Glioblastoma

The Moffit Cancer Center website cites memory loss, seizures, difficulty seeing or speaking, weakness on one side of the body, temperament changes and other neurological deficits as symptoms of glioblastoma. However, the region of the brain in which the tumor originates can cause these symptoms to vary.

Glioblastoma is the most common malignant brain tumor and is often associated with a poor prognosis, according to an article from the National Library of Medicine, which went on to explain that, in 2023, 14 months was the expected median survival for patients with the disease, and the five-year survival rate is just 5% to 10%.

According to the Moffit Cancer Center, recurrent glioblastoma can appear anywhere in the brain or spinal cord; however, most sites of recurrence are found near the original tumor.

There is currently no standard treatment option for the disease, and recurrence of glioblastoma is the usual way of progression, according to the National Library of Medicine, and although there is no current standard of care treatments for the disease, surgical procedure, radiotherapy and systemic chemotherapy, or targeted drugs are commonly used treatment methods.

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