JERUSALEM, June 8, 2022 /PRNewswire/ — Alpha Tau Medical Ltd. (Nasdaq: DRTS and DRTSW), (“Alpha Tau” or the “Company”), the developer of the innovative alpha-radiation cancer therapy Alpha DaRT™, announced today that the U.S. Food and Drug Administration (FDA) has conditionally approved the Company’s Investigational Device Exemption (IDE) application to initiate its multi-center pivotal study for the treatment of recurrent cutaneous Squamous Cell Carcinoma (SCC) using the Alpha DaRT.
The clinical study, entitled “A Prospective Multicenter, Pivotal, Single Arm, Open Label Clinical Study to Assess the Efficacy and Safety of Intratumoral Alpha DaRT for the Treatment of Patients with Recurrent Cutaneous Squamous Cell Carcinoma” has been approved to enroll up to 86 U.S. patients at up to 20 institutions in the U.S., in addition to any sites that may be added outside the U.S., and will focus on patients with recurrent cutaneous SCC who have failed at least first line standard of care therapy and are not indicated for another curative standard of care therapy.
“We are very excited about the upcoming commencement of our U.S. pivotal study, undoubtedly our most significant clinical trial to date,” commented Alpha Tau CEO Uzi Sofer. “Our receipt of FDA conditional approval of our IDE submission is a critical milestone on our journey to bringing this exciting new therapy to patients in the U.S. and around the world”
Dr. Robert B. Den, Alpha Tau Chief Medical Officer, added, “We are thrilled to have received FDA conditional approval of our IDE, after tremendous focus on the U.S. over the past year, including successful completion of our pilot study and the upcoming initiation of this pivotal study under the FDA’s Breakthrough Device Designation Program. We have seen tremendous engagement and excitement from dozens of leading institutions in the U.S. and around the world, keen to be part of this study, and look forward to working with them on this clinical study.”
Yaniv Sagie, Alpha Tau VP Quality and Regulatory Affairs, noted, “This amazing milestone represents the culmination of Alpha Tau’s rigorous teamwork and unwavering commitment to quality and regulatory excellence.”