Alpha Tau Announces FDA Approval of IDE to Initiate Multi-Center Investigator-Initiated Study of Alpha DaRT in Immunocompromised Patients with Recurrent cSCC

-Trial to focus on particularly vulnerable subset of patients, following strong clinician interest in use of the Alpha DaRT in this patient population -

JERUSALEM, Sept. 20, 2024 (GLOBE NEWSWIRE) -- Alpha Tau Medical Ltd. ("Alpha Tau", or the “Company”) (NASDAQ: DRTS, DRTSW), the developer of the innovative alpha-radiation cancer therapy Alpha DaRT, announced today that the U.S. Food and Drug Administration (FDA) has approved an Investigational Device Exemption (IDE) application to initiate a multi-center study for the treatment of recurrent cutaneous Squamous Cell Carcinoma (cSCC) in immunocompromised patients using the Alpha DaRT.

The clinical study, which is an investigator-initiated study led by the Winship Cancer Institute of Emory University in Atlanta, has been approved to enroll up to 28 U.S. patients at up to 8 institutions in the U.S., and will focus on patients with recurrent cSCC who have a weakened immune system due to any primary or secondary immunodeficiencies, excluding diabetes. The primary efficacy objective of the study is the objective response rate (ORR) to the treatment, as measured by best overall response. Secondary efficacy objectives include progression-free survival, overall survival and local control up to twelve months after treatment, and the safety objective is the measurement of any related adverse events.

A 2015 article in Journal of Clinical Medicine noted that non-melanoma skin cancers represent a major cause of morbidity for patients after organ transplantation, and cSCC is the most common skin cancer seen in this population, with a 65–100 fold greater incidence in organ transplant recipients compared to the general population. For example, a 2003 article in the New England Journal of Medicine cited a number of sources indicating that 50% or more of Caucasian transplant recipients will ultimately develop cutaneous carcinomas.

In addition, a 2019 article in JAMA Otolaryngology – Head & Neck Surgery found that immunosuppression is independently associated with a worse outcome in cSCC, with a 2.32-times increased risk of disease-specific death, after adjusting for assorted demographic factors.

"As we continue to progress in our ReSTART multi-center pivotal trial for recurrent cutaneous SCC, a number of investigators asked about the ability to treat immunocompromised patients, who are ineligible for the ReSTART trial," commented Alpha Tau CEO Uzi Sofer. "Emory University is an important partner of ours and we are proud to work with them in initiating a trial for this population. Given the continued requests we receive from clinicians to help them treat immunocompromised patients, we are confident that a successful clinical trial can help deliver an important new potential alternative for these patients."