The designation has been granted for the technology to treat squamous cell carcinoma of the skin and oral cavity without curative standard of care
Israeli oncology therapeutics firm Alpha Tau Medical has secured breakthrough device designation from the US Food and Drug Administration (FDA) for its Alpha DaRT (Diffusing Alpha-emitters Radiation Therapy).
Alpha DaRT is an advanced technology that allows a potent and uniquely conformal alpha-irradiation of solid tumours.
The FDA status applies to the technology to treat squamous cell carcinoma of the skin and oral cavity without curative standard of care.
The treatment involves intratumoral insertion of Radium-224, which facilitates the release and diffusion of alpha-emitting radioisotopes. It will help release alpha particles to destroy the tumour.
Alpha DaRT mainly targets the tumour and spares the healthy tissue around it, as the alpha-emitting atoms diffuse only a short distance.
Alpha Tau CEO Uzi Sofer said: “The FDA’s recognition of the Alpha DaRT as a Breakthrough Device is a tremendous milestone for the company, as we seek to bring our revolutionary technology to patients in need.
“This confirms our long-standing hopes and expectations for this product, and comes at the perfect time to accelerate our clinical trial program that is moving ahead rapidly now in the US.”
The breakthrough designation was provided based on data from a pilot clinical study of Alpha DaRT to treat SCC of the skin, head and neck.
According to the company, the data revealed that almost 80% of the lesions demonstrated a complete response, and 100% showed a partial or complete response alongside a mild safety profile.
Preclinical studies involving the usage of Alpha DaRT revealed a response in all tested solid tumours, including pancreatic, lung, breast, and prostate tumor cells.
As part of the Alpha DaRT clinical trial programme, a skin cancer feasibility trial currently being carried out at Memorial Sloan Kettering Cancer Center in New York and other sites across the US.
In June last year, Alpha Tau secured $26m in a Series B equity financing to support the clinical development of its Alpha DaRT therapy.