On November 26, 2019 Alpha Tau Medical is reported the publication of the results of its first clinical trial of Alpha DaRT, a novel alpha radiation cancer treatment, in the International Journal of Radiation Oncology, Biology, and Physics, the official journal of the American Society for Radiation Oncology (Press release, Alpha Tau Medical, NOV 26, 2019, View Source [SID1234551741]).
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The objectives of the trial, conducted in Israel and in Italy, were to establish the feasibility, safety and efficacy of Alpha DaRT for management of patients with squamous cell carcinoma of the skin and head and neck region. 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.
Efficacy endpoints demonstrated a 100% overall response rate with a 78.6% complete tumor response rate. This is quite noteworthy given that over 40% of the patients had undergone prior radiation therapy to the affected area, and 61% 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.
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.