Sona Nanotech Inc (CSE:SONA, OTCQB:SNANF) CEO David Regan talked with Proactive about a major regulatory milestone achieved by the company’s golden nanorod therapy platform. The company announced that its therapy has successfully passed a key safety study, a required step before proceeding to human clinical trials.
Regan emphasized that their gold nanorods are "biocompatible, and they are by design," noting they are manufactured without a specific toxin used in other approaches. While the company has consistently stated this, regulators such as the FDA and Health Canada require formal safety studies to confirm no toxic effects at various dosage levels.
"Even at 100 times the anticipated dosage level on a relative per kilogram basis... we came through with flying colors," Regan told Proactive.
The safety study involved multiple dosing levels—low, medium, and high—and was conducted at an FDA-certified lab. This certification is essential to meet the standards for potential human use. Regan explained that the data collected is vital for discussions with both U.S. and Canadian regulators as the company prepares to initiate clinical trials.
He also positioned Sona’s therapy as a potential advancement beyond immunotherapies, which have toxicity issues and variable response rates.