On May 13, 2024 Alpha Tau Medical Ltd. ("Alpha Tau", or the "Company") (NASDAQ: DRTS, DRTSW), the developer of the innovative alpha-radiation cancer therapy Alpha DaRT, reported that its first patient with liver cancer metastases has been treated in a feasibility and safety study of Alpha DaRT at the McGill University Health Center in Montreal, Canada (Press release, Alpha Tau Medical, MAY 13, 2024, View Source [SID1234643130]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
The trial seeks to recruit up to 10 patients who are eligible for a two-staged hepatectomy to resect liver metastases of colorectal cancer. Specifically, in the first stage, as many metastatic tumors as possible will be surgically removed in a non-curative intervention, while Alpha DaRT sources will be inserted into a separate tumor in the second liver lobe, and in the second stage, after allowing for the resected liver to regenerate naturally, the portion of the liver with the Alpha DaRT sources will be surgically removed.
The study primarily aims to examine the feasibility of delivering Alpha DaRT sources into the liver metastases, as well as the safety of utilizing the Alpha DaRT sources in the liver by assessing the frequency and severity of related adverse events. The study also aims to examine Alpha DaRT’s efficacy in terms of radiological response, assessed after insertion of the Alpha DaRT sources, and via pathological response, assessed after the second stage of surgery. Additional information about the trial can be found at View Source
Alpha Tau CEO Uzi Sofer commented, "The start of this trial marks a big milestone towards addressing the urgent need for new therapeutic options in treating patients with liver metastases. This trial is part of our overall strategy to showcase the broad use and potential of the Alpha DaRT in other hard-to-treat indications such as cancers of the brain, lung, vulva and pancreas. We would like to thank Dr. Peter Metrakos and his team at the McGill University Health Center for enrolling and treating the first patient in this highly significant feasibility and safety trial."
Peter Metrakos, MD, CM, FACS, FRCSC, Professor of Surgery, Pathology and Anatomy and Cell Biology, Director of Hepato-Pancreato-Bilary Surgery and Senior Scientist, McGill University Health Centre -Research Institute, Cancer Research Program, Department of Surgery at McGill University, and the principal investigator of the trial, commented "Liver Metastases associated with colorectal cancer is of major concern and a leading cause of patient mortality with limited effective treatment options. We are encouraged by the early results of Alpha DaRT treatment in other tumor types and are hopeful that the Alpha DaRT treatment will offer better outcomes to these patients with such a challenging disease."
Robert Den MD, Alpha Tau CMO commented, "While we continue to accrue patients with cutaneous recurrent SCC to the ongoing pivotal ReSTART trial, we also look to expand the use of the Alpha DaRT technology to high unmet medical need indications in internal organs such as liver metastases. This trial is particularly exciting for us in light of previous preclinical work that has demonstrated the ability of Alpha DaRT to generate an observed systemic immune response when used to treat a colorectal tumor model, and we hope to better understand the effect of Alpha DaRT on liver metastases and immune cell populations in human patients. We look forward to the preliminary results of this trial, which we hope will further our goal of advancing the use of Alpha DaRT across a range of indications and helping patients worldwide."
This clinical study is the next phase of a multi-year research collaboration program between the McGill University Research Center and the Alpha Tau Medical research team. This collaboration started with translation experiments using orthotopic animal models that mimic human liver colorectal metastatic disease, showing a reduction in tumor growth rate when using Alpha DaRT compared to control and changes in the hepatic immune microenvironment.
About Alpha DaRT
Alpha DaRT (Diffusing Alpha-emitters Radiation Therapy) is designed to enable highly potent and conformal alpha-irradiation of solid tumors by intratumoral delivery of radium-224 impregnated sources. When the radium decays, its short-lived daughters are released from the sources and disperse while emitting high-energy alpha particles with the goal of destroying the tumor. Since the alpha-emitting atoms diffuse only a short distance, Alpha DaRT aims to mainly affect the tumor, and to spare the healthy tissue around it.