Alpha Tau Medical Ltd. is making strides in the development and clinical application of its Alpha DaRT (Diffusing Alpha-emitters Radiation Therapy) technology. The company's recent corporate update highlights significant advancements, including FDA support and progress in clinical trials targeting various solid tumors.
FDA's Total Product Life Cycle Advisory Program (TAP) Acceptance
Alpha Tau's Alpha DaRT has been accepted into the FDA's Total Product Life Cycle Advisory Program (TAP) to accelerate market access for patients with recurrent glioblastoma multiforme (GBM). TAP's primary goal is to expedite patient access to innovative medical devices by providing strategic communications with the FDA and facilitating engagement with key parties. This program aims to reduce the time, cost, and uncertainty of patient access through reimbursement and commercial adoption following FDA authorization.
Clinical Trial Advancement in Recurrent Lung Cancer
The first patient with recurrent lung cancer has been treated in a clinical trial at Hadassah Medical Center in Jerusalem, Israel. This study is designed to assess the safety and feasibility of delivering Alpha DaRT sources into the lung using an endobronchial ultrasound (EBUS) procedure. The trial will evaluate the rate of successful source placement and any treatment-related adverse events.
IDE Approval for Cutaneous Squamous Cell Carcinoma Study
The 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. This investigator-initiated study, led by the Winship Cancer Institute of Emory University in Atlanta, plans to enroll up to 28 U.S. patients across up to 8 institutions. The focus is on patients with recurrent cSCC who have weakened immune systems due to primary or secondary immunodeficiencies, excluding diabetes.
Anticipated Milestones
Alpha Tau anticipates a response from the PMDA in Japan in Q1 2025 for pre-market approval of Alpha DaRT in patients with recurrent head and neck cancer. The company also plans to release data from pancreatic cancer trials in Canada and Israel in Q1 2025. Completion of patient recruitment in the ReSTART pivotal U.S. multi-center trial in recurrent cutaneous squamous cell carcinoma is targeted for H1 2025. Additionally, data from a combination trial of Alpha DaRT with pembrolizumab (Keytruda) is expected in H1 2025, with the first brain cancer treatment also targeted for H1 2025.
Financial Position
As of September 30, 2024, Alpha Tau Medical reported cash, cash equivalents, and deposits totaling $68.4 million. The company anticipates that this balance will be sufficient to fund operations for at least the next two years.
About Alpha DaRT
Alpha DaRT (Diffusing Alpha-emitters Radiation Therapy) delivers highly potent and conformal alpha-irradiation to solid tumors via intratumoral delivery of radium-224 impregnated sources. The short-lived daughters released from the decaying radium disperse and emit high-energy alpha particles, aiming to destroy the tumor while sparing surrounding healthy tissue due to the short distance the alpha-emitting atoms diffuse.
