Innovative radiotherapy for glioblastoma! Alpha DaRT is designated as a breakthrough device by the FDA
Glioblastoma is the most malignant type of glioma, while glioblastoma multiforme (GBM) accounts for 40%-50% of gliomas, and the average five-year survival rate of patients is less than 10%. Recently, the U.S. FDA has awarded Alpha DaRT, an innovative therapy of alpha radiation, the title of breakthrough device for the treatment of patients with recurrent glioblastoma multiforme.
What is Alpha DaRT therapy?
Alpha DaRT treatment involves injecting a "seed" containing radioactive radium-224 into the tumor. When the unstable radioactive radium-224 fissions, it releases high-energy alpha particles that destroy the tumor. Because the diffusion distance of emitted alpha atoms is very short, Alpha DaRT does not affect surrounding healthy tissue while destroying the tumor. Eventually, the radioactive radium-224 fissions into stable, non-radioactive lead-208. Its radiation level is very low and does not cause adverse effects. Individual alpha particles can only travel a very short path in tumor tissue and therefore cannot penetrate to cover the entire tumor. Alpha DaRT's revolutionary technology utilizes the radioactive decay of the radium-224 isotope to propel the alpha particles throughout the tumor and exert their effects.
Alpha DaRT International Research Status
Current radioactive particle implantation therapy primarily uses radioactive isotopes 125I, 198Au, and 103Pd as implants. These substances emit gamma rays during decay, thereby killing tumor cells. In contrast, alpha particles have a larger mass, easily cutting double-stranded DNA in cancer cells, while having the lowest penetration. Furthermore, current radioactive particle therapy is ineffective against metastatic and spread tumors. Alpha DaRT, however, has shown the ability to stimulate anti-tumor immunity, thereby eliminating distant metastatic tumor cells.
In a preclinical study of Alpha DaRT's treatment of solid tumors, the researchers hypothesized that active in situ tumor ablation can release tumor antigen and risk signals to achieve antitumor T cell response. In turn, cancer cells may be destroyed with primary and distant metastasis. The study showed that when Alpha DaRT is used in combination with chemotherapy and immunostimulants, it may provide benefits to subjects with solid metastases.
Human studies using Alpha DaRT have been conducted in patients with head, neck and skin cancer, showing acceptable safety and significant tumor response.
In the first prospective human trial, of the 31 cases of 28 patients with recurrent squamous cell carcinoma who had received surgery or radiotherapy in the past, 22 cases (78.6%) had complete remission from treatment, and 6 (21.4%) had partial remission. Acute toxicity includes swelling and mild skin ulcers caused by local pain and erythema at the implant site. It is worth noting that in the first 3 to 5 weeks after treatment, 90% of patients' pain and grade 2 skin ulcers were relieved.
This designation is based on preliminary evidence that Alpha DaRT will provide better efficacy in this population compared to current standard treatment options, and will allow the review process to be accelerated and the development of clinical trials to be promoted.
Reminder: Previously, the FDA awarded Alpha DaRT the title of breakthrough device in June 2021 for the treatment of skin cancer patients who cannot receive curative treatment. This breakthrough device recognition has brought new hope to GBM patients. It is hoped that this new therapy will be approved as soon as possible and applied to clinical practice as soon as possible, for the benefit of more cancer patients.
