Sona Nanotech Inc (CSE:SONA, OTCQB:SNANF) announced that it has dosed the first patient in an early feasibility study of its Targeted Hyperthermia Therapy (THT) cancer treatment.
The study is evaluating the safety, tolerability, and preliminary efficacy of its THT therapy in patients with advanced melanoma who have not responded to standard immunotherapy treatments.
It involves two treatments administered one week apart and is designed to assess tumor growth inhibition and immune system engagement.
Initial results are expected in the summer, with final results anticipated in the fall.
The trial will assess the technology’s ease of setup, administration across various tumor types, reproducibility in clinical settings, required resources, and time needed for treatment delivery.
Participants will be monitored for treatment tolerability, adverse events, clinical response, and pathological immune response directly linked to the therapy.
Sona Nanotech believes THT may offer advantages over existing immunotherapy approaches, which often have limited effectiveness and side effects.
"Our unique therapy aims to modify tumors making them more visible to the immune system with a view to enabling an elimination of the cancer,” chief medical officer Dr Carman Giacomantonio said.
“We have smartly designed this inaugural study to also provide us with some key, first ever reported, insights into its effect in human cancer. Success in this study will enable us to proceed to our next planned study that will more critically evaluate the biological effects and clinical outcomes of this exciting technology."
David Regan, Sona's CEO, noted the years of research and many preclinical studies that have culminated in the milestone.
“We plan to follow this critical first clinical step quickly with a second, more expansive human trial following further engagement with regulators, as well as a peer-reviewed article in a leading scientific journal detailing our findings,” Regan said.
“We also expect the learnings from this study to help inform on THT's potential for complementing the treatment of other cancer types."