A novel alpha radiation cancer treatment designed by Alpha Tau Medical to treat squamous cell carcinoma of the skin and head and neck region showed significant promise in its first clinical trial in Israel and Italy, according to the results that were published in the International Journal of Radiation Oncology, Biology and Physics, the official journal of the American Society for Radiation Oncology.
Alpha Tau Medical Ltd, an Israeli medical device company, focuses on research, development and commercialization of the Alpha DaRT for the treatment of solid tumors. The treatment currently being worked on by the company, which was founded in 2016, is based on technology that was initially developed by Prof. Itzhak Kelson and Prof. Yona Keisari from Tel Aviv University.
The objectives of the trial were to establish the feasibility, safety and efficacy of the Alpha DaRT treatment for management of patients with squamous cell carcinoma of the skin and head and neck region, according to Alpha Tau Medical.
Alpha DaRT™ (Diffusing Alpha-emitters Radiation Therapy) enables highly potent and conformal alpha-irradiation of solid tumors. The treatment is delivered by intratumoral insertion of radium-224 impregnated seeds. When the radium decays, its short-lived daughters are released from the seed, and disperse while emitting high-energy alpha particles that destroy the tumor. Since the alpha-emitting atoms diffuse only a short distance, Alpha DaRT mainly affects the tumor, sparing the healthy tissue around it.
There was a 100 percent overall response rate, meaning “100 percent of the tumors reacted to the treatment, including aggressive and heavily pre-treated ones,” a spokesperson from Alpha Tau Medical told JewishPress.com in an email response. “Seventy-eight percent of the tumors treated were entirely eradicated, or the treatment led to complete shrinkage of the tumor in 78 percent of the cases,” the company added.
“All 28 evaluable treated lesions underwent successful placement of the Alpha DaRT™ seeds, and there were no severe (Grade 3 or higher) toxicities noted. Common toxicities observed included local pain, redness at the implantation site – frequently followed by swelling, and mild skin ulceration. There were no systemic toxicities noted. All toxicities were mild to moderate and resolved within 3-5 weeks,” the company said.
More than 40 percent of the patients had undergone prior radiation therapy to the affected area and 61 percent of patients overall had received some form of prior therapy.
The principal investigator of the Israeli arm of the trial, radiation oncologist Prof. Aron Popovtzer, MD, from Rabin Medical Center in Israel, explained, “The results we obtained from our first clinical trial in human squamous cell carcinoma patients confirm the promising findings from preclinical studies.
“The observed tumor response rates and survival metrics seem especially impressive given this elderly (median age 80.5 years) and heavily pretreated patient sample. Overall, these impressive outcomes serve as an excellent basis for future trials in other tumor types.”
The Italian arm of the trial was led by Dr. Salvatore Roberto Bellia from the IRST (Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori).
Future clinical trials will also investigate Alpha DaRT in other oncology indications, as a monotherapy or in combination with various systemic therapies.