Sona Nanotech Inc (CSE:SONA, OTCQB:SNANF) announced positive results from a preclinical safety study evaluating the toxicity of its proprietary gold nanorods, fulfilling a prerequisite required by the US Food and Drug Administration (FDA) for advancing to full human clinical trials.
The study assessed the safety, tolerability, and tissue distribution of Sona’s gold nanorods in three groups of twenty rats, each administered different dosage levels intravenously.
According to the company, the results showed a favorable safety profile, with tissue distribution consistent with known nanoparticle pharmacokinetics and no evidence of acute or systemic toxicity.
The findings will be submitted to the FDA and that it intends to continue following the agency’s recommendations to support Sona's application for an investigational device exemption needed for broader human studies.
"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,” Sona Nanotech’s chief medical officer Dr Carman Giacomantonio said in a statement.
“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.”
The study was conducted by CBSET, a US-based FDA Good Laboratory Practice (GLP)-compliant contract research organization.
"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,” said Donald Hodges, Head of Integrated Toxicology at CBSET.
“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."
Shares of Sona Nanotech were up 7.1% in Canada at C$0.38.