On July 23, 2025 Sona Nanotech Inc. (CSE: SONA) (OTCQB: SNANF) (the "Company", "Sona"), an oncology-focused life sciences company developing innovative therapies based on its uniquely biocompatible gold nanorod technology, reported it has received Nova Scotia Health Research Ethics Board ("REB") approval to conduct its proposed pilot human clinical trial study (the "Pilot Study") of its Targeted Hyperthermia Therapy ("THT") cancer treatment with late-stage melanoma patients (Press release, Sona Nanotech, JUL 23, 2025, View Source [SID1234654484]). Sona’s THT Pilot Study is being planned as a multi-centre clinical trial for 30-40 patients and is subject to, amongst other things, securing medical device Investigational Testing Authorization ("ITA") from Health Canada.
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Sona CEO, David Regan, commented, "Cases of melanoma have tripled in 30 years in Canada where over 1,300 people die every year from this disease. For that reason, we are excited to be laying the foundation for the next steps necessary to get our THT cancer treatment into clinics. With ethics approval to conduct a Pilot Study in Canada, we now look forward to the possibility of a study of our therapy with up to 40 patients suffering from late-stage melanoma, subject to regulatory approval."
Sona’s THT Pilot Study will be designed to incorporate various learnings from its current Early Feasibility Study and to help further evaluate the safety and preliminary efficacy of Sona’s THT therapy with a larger pool of patients. The information developed from a Pilot Study would inform the design of a larger randomized potential ‘pivotal’ clinical study which would be subject to regulatory approval. The Pilot Study is anticipated to be begin in late 2025 or early 2026.