Alpha Fusion Inc., headquartered in Chiyoda-ku, Tokyo, has announced the start of a company-sponsored Phase I clinical trial for the alpha-emitting radiopharmaceutical af-001, specifically designed for patients with differentiated thyroid cancer who have not previously undergone radioactive iodine (RAI) therapy. This trial is a continuation of research stemming from an investigator-initiated Phase I study conducted at The University of Osaka.
The trial, identified as jRCT2031250472, consists of two parts: Part Ia and Part Ib. In Part Ia, the maximum tolerated dose (MTD) will be established for a single intravenous administration of af-001 in patients whose cancer is resistant to or who cannot tolerate standard treatments. Part Ib will assess the safety and efficacy of multiple administrations of af-001 to establish the recommended dose for future Phase II trials targeting RAI-naïve patients with differentiated thyroid cancer.
Part Ia of the trial is set to take place at the National Cancer Center Hospital East, led by Dr. Makoto Tahara, Chief of the Department of Head and Neck Medical Oncology, while Part Ib will involve multiple sites across Japan. The overarching aim of the clinical development of af-001 is to secure regulatory approval for its use in patients with RAI-naïve differentiated thyroid cancer.
Sunao Fujioka, CEO of Alpha Fusion, expressed optimism regarding the trial, stating, “Based on the achievements of the investigator-initiated Phase I study in patients refractory or intolerant to standard therapies, we expect to maximize the potential of af-001 by confirming its safety and efficacy in RAI-naïve patients. Alpha Fusion is fully committed to advancing the clinical development of af-001, with the ultimate goal of providing outpatient alpha-emitting radiopharmaceutical therapy to more patients with thyroid cancer.”
The manufacturing of af-001 adheres to GMP standards for investigational products, in collaboration with the Kobe City Medical Center General Hospital. Once produced, the radiopharmaceutical will be quickly delivered to the National Cancer Center Hospital East.
The need for innovative treatment options arises from the challenges associated with RAI therapy, which remains the standard treatment for differentiated thyroid cancer. In some cases, patients may require multiple RAI treatments due to metastases or inadequate therapeutic responses, which can lead to prolonged hospital stays and significant psychological and financial stress. Reports indicate an average waiting time of about 3.7 months for RAI therapy in Japan, with some facilities experiencing wait times exceeding six months.
af-001 utilizes astatine-211 (At-211) as its active ingredient, which targets differentiated thyroid cancer cells through the sodium/iodide symporter (NIS). This radiopharmaceutical emits alpha particles, which are more potent than beta particles, causing double-strand DNA breaks in cancer cells, thereby promoting tumor regression while minimizing damage to surrounding healthy tissues.
The current trial builds on earlier findings from an investigator-initiated Phase I clinical trial of NaAt, which demonstrated safety and tolerability in patients with differentiated thyroid cancer resistant to standard therapies and noted significant reductions in tumor markers.
Alpha Fusion Inc. is committed to advancing next-generation radiopharmaceutical therapies through innovative research and collaboration with medical and research institutions, aiming to provide new therapeutic options in oncology and enhance the field of precision radiopharmaceutical medicine.
