Alpha Fusion Launches Clinical Trial for Innovative Thyroid Cancer Treatment with af-001

Alpha Fusion Launches Clinical Trial for af-001

In a significant development for thyroid cancer treatment, Alpha Fusion Inc. has announced the commencement of a company-sponsored Phase I clinical trial of its innovative alpha-emitting radiopharmaceutical, af-001. This trial targets differentiated thyroid cancer (DTC) patients, specifically those who have not undergone radioactive iodine (RAI) therapy. The trial is registered under the identifier jRCT2031250472, and its design is rooted in encouraging findings from a previous investigator-initiated study at The University of Osaka.

Overview of the Clinical Trial

The clinical trial is divided into two parts: Part Ia and Part Ib. Part Ia will focus on establishing the maximum tolerated dose (MTD) of af-001. This phase will enroll patients with differentiated thyroid cancer who are refractory to, or cannot tolerate standard therapies. Part Ib, on the other hand, will assess the efficacy and safety of multiple intravenous doses of af-001, aiming to identify the recommended dose for subsequent Phase II trials specifically for RAI-naïve patients.

Prominent figures in this study include Dr. Makoto Tahara, who will lead Part Ia at the National Cancer Center Hospital East, alongside various sites across Japan for Part Ib. The ultimate goal of this trial is to secure regulatory approval for af-001 as a treatment option for patients suffering from RAI-naïve differentiated thyroid cancer.

The Importance of af-001

Currently, RAI therapy is considered a standard approach for treating differentiated thyroid cancer. However, it presents challenges, particularly for patients with extensive metastasis or insufficient response to treatment. These patients often face the need for repeated RAI sessions, creating additional stress and financial burdens associated with hospitalization due to strict radiation safety regulations in Japan. Reports indicate that patients might wait as long as six months for RAI therapy, exacerbating the need for alternative, outpatient treatment options that can effectively reduce tumor size without the risks associated with current methods.

Af-001 emerges as a promising contender. This radiopharmaceutical leverages astatine-211 ([211At]NaAt) as its core ingredient, which is specifically absorbed by differentiated thyroid cancer cells through the sodium/iodide symporter (NIS). The mechanism of action involves emitting high-energy alpha particles that cause double-strand breaks in the cancer cells’ DNA, potentially leading to tumor regression. One of its significant advantages is the limited range of these alpha particles, which minimizes collateral damage to surrounding healthy tissues, making outpatient treatments feasible.

Transition from Research to Reality

The clinical development of af-001 is structured around robust scientific findings. The prior investigator-initiated Phase I trial indicated its safety and therapeutic potential in the same patient demographic that the current company-sponsored trial now targets. Preliminary results showed promising reductions in tumor markers, with a noted decrease of over 50% in thyroglobulin levels in some patients.

CEO Sunao Fujioka articulated optimism in advancing af-001's clinical development, emphasizing its potential to revolutionize treatment paradigms for thyroid cancer and alleviate burdens associated with conventional therapies. He mentioned the broader ambition of Alpha Fusion to pursue various applications of At-211 in developing novel radiopharmaceuticals across multiple cancer types.

Conclusion

As Alpha Fusion embarks on this critical clinical trial phase, the focus remains on harnessing the unique properties of af-001 to enhance treatment options available to patients dealing with differentiated thyroid cancer. With an evolving landscape in cancer treatment, the outcomes of this trial could significantly impact therapeutic strategies, establishing af-001 as a vital tool in oncology.

For more information about Alpha Fusion and updates on af-001, please visit Alpha Fusion's website.