Sona Nanotech Receives Ethics Committee Approval for Cancer Trial Pilot Study

Sona Nanotech has received ethics committee approval for a pilot cancer study, marking the next step in its clinical development pathway. The study will involve 30-40 patients and aims to build on the company's current early feasibility study focused on late-stage melanoma patients. Results from the current study are expected within the quarter. The pilot study is expected to begin by the end of this year or early next year, subject to regulator approval.

Sona Nanotech Inc. (CSE: SONA) (OTCQB: SNANF) has received approval from the Nova Scotia Health Research Ethics Board (REB) to proceed with a pilot human clinical trial study (Pilot Study) of its Targeted Hyperthermia Therapy (THT) cancer treatment for late-stage melanoma patients. The company's THT Pilot Study is designed to be a multi-centre trial involving 30-40 patients and is subject to securing medical device Investigational Testing Authorization (ITA) from Health Canada.

The Pilot Study will build on Sona's current Early Feasibility Study, incorporating learnings to further evaluate the safety and preliminary efficacy of the THT therapy with a larger patient pool. The information gathered from this study will inform the design of a larger, randomized potential 'pivotal' clinical study, which will also require regulatory approval. The Pilot Study is anticipated to commence in late 2025 or early 2026.

David Regan, CEO of Sona Nanotech, commented, "Cases of melanoma have tripled in 30 years in Canada, with over 1,300 people dying annually from this disease. 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."

The THT Pilot Study is part of Sona's ongoing efforts to develop Targeted Hyperthermia™, a photothermal cancer therapy that uses therapeutic heat to treat solid cancer tumors. The heat is delivered to tumors by infrared light absorbed by Sona's gold nanorods, which are re-emitted as heat. This therapy is designed to stimulate the immune system, shrink tumors, inactivate cancer stem cells, and increase tumor perfusion, enhancing the effectiveness of drug therapy.

Sona has developed multiple proprietary methods for the manufacture of gold nanoparticles, which are used in both cancer therapies and diagnostic testing platforms. The company's gold nanorod particles are CTAB-free, eliminating toxicity risks associated with other gold nanorod technologies in medical applications.

The Pilot Study is subject to various risks and uncertainties, including the possibility that Sona may not secure the remaining required regulatory approvals, enroll study participants in a timely manner, or successfully obtain sufficient clinical data to submit regulatory submissions. Additionally, there is a risk that THT may not prove to have the benefits currently anticipated.

For more information, please contact:
David Regan, CEO
+1-902-442-0653
david@sonanano.com

References:
[1] https://www.biospace.com/press-releases/sona-announces-canadian-melanoma-clinical-pilot-study-ethics-approval
[2] https://www.marketscreener.com/news/sona-announces-canadian-melanoma-clinical-pilot-study-ethics-approval-ce7c5cd2d88afe26
[3] https://www.newsfilecorp.com/company/5500/Sona-Nanotech-Inc.