Sona Successfully Completes FDA-Required Toxicity Study
May 27, 2025 8:27 AM EDT | Source: Sona Nanotech Inc.
Halifax, Nova Scotia--(Newsfile Corp. - May 27, 2025) - Sona Nanotech Inc. (CSE: SONA) (OTCQB: SNANF) (the "Company", "Sona") is pleased to announce positive results from a required preclinical safety study evaluating for toxicity issues when animals are injected with its proprietary gold nanorods, conducted by CBSET, Inc.
Donald Hodges, PhD, DSP, DABT, Head of Integrated Toxicology at CBSET, Inc., commented, "This study indicates Sona's gold nanorods were well tolerated, with no signs of acute or systemic toxicity at 100 times the proposed clinical dosage level. The tissue distribution profile was consistent with known nanoparticle pharmacokinetics. These results support the continued development for nanomedical applications in general and for Sona's novel, developing cancer therapy, in particular."
Sona Nanotech CMO, Dr. Carman Giacomantonio, commented, "This study shows the biocompatibility of Sona's cancer therapy at up to 100 times the relative dose level expected to be administered in humans with Sona's THT cancer therapy for melanoma. Given this safety profile, clinicians have reason to be excited about the prospects for this therapy as a less harmful potential alternative to immunotherapy drugs that can help patients but have toxicity issues with associated side effects. Next, we expect these preclinical safety study results to provide significant comfort to regulators when considering our applications for clinical trials in which we will seek to establish THT's efficacy."
The study evaluated the safety, tolerability, and tissue distribution of Sona's nanoparticles in three cohorts of twenty rats each at different dosage levels following intravenous administration. Sona's uniquely biocompatible gold nanorods demonstrated "a favorable safety profile, with tissue distribution consistent with nanoparticle pharmacokinetics and no evidence of acute or systemic toxicity." The study, conducted by a Food and Drug Administration ("FDA") Good Laboratory Practise ("GLP") compliant contract research organization, represents a critical milestone in the Company's translational development pathway and is an FDA prerequisite to initiating full human clinical trials. As a GLP study, the results will be reported to the FDA and the Company plans to continue to follow the FDA's recommendations for its full safety study program to qualify for the investigational device exemption required for broader human studies.
Contact:
David Regan, CEO
+1-902-442-0653
david@sonanano.com
About Sona Nanotech Inc.
Sona Nanotech is developing Targeted Hyperthermia™, a photothermal cancer therapy, which uses therapeutic heat to treat solid cancer tumors. The heat is delivered to tumors by infrared light that is absorbed by Sona's gold nanorods in the tumor and re-emitted as heat. Therapeutic heat (42-48°C) stimulates the immune system, shrinks tumors, inactivates cancer stem cells, and increases tumor perfusion – thus enabling drugs to reach all tumor compartments more effectively. Targeted Hyperthermia promises to be safe, effective, minimally invasive, competitive in cost, and a valuable adjunct to drug therapy and other cancer treatments.
Sona has developed multiple proprietary methods for the manufacture of gold nanoparticles which it uses for the development of both cancer therapies and diagnostic testing platforms. Sona Nanotech's gold nanorod particles are cetyltrimethylammonium ("CTAB") free, eliminating the toxicity risks associated with the use of other gold nanorod technologies in medical applications.
CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING INFORMATION: This press release includes certain "forward-looking statements" under applicable Canadian securities legislation, including statements regarding the anticipated applications and potential opportunities of Targeted Hyperthermia Therapy, and Sona's preclinical and clinical study plans. Forward-looking statements are necessarily based upon a number of assumptions or estimates that, while considered reasonable, are subject to known and unknown risks, uncertainties, and other factors which may cause the actual results and future events to differ materially from those expressed or implied by such forward-looking statements, including the risk that Sona may not be able to successfully obtain sufficient clinical and other data to submit regulatory submissions, raise sufficient additional capital, secure patents or develop the envisioned therapy, and the risk that THT may not prove to have the benefits currently anticipated. There can be no assurance that such statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Accordingly, readers should not place undue reliance on forward-looking statements. Sona disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.
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