Sona Nanotech clears Endotoxin testing, preps for first-in-human Gold Nanorod trial
Last updated: 04:15 22 May 2025 AEST, First published: 03:15 22 May 2025 AEST
Sona Nanotech Inc chief medical officer Dr Carman Giacomantonio joined Steve Darling from Proactive to announce a critical advancement as the company prepares for its first-in-human clinical study. Sona has successfully completed bacterial endotoxin testing on its biocompatible gold nanorods using the Limulus Amebocyte Lysate (LAL) method, a widely accepted industry standard for evaluating medical and pharmaceutical products.
The testing was conducted at a GLP-accredited U.S. laboratory operated by a leading global provider of MedTech and pharmaceutical testing services. The results showed that all tested samples passed with endotoxin levels below detection limits, ensuring that Sona's nanorods meet stringent safety standards. In addition, Positive Product Controls confirmed the test’s validity, with recovery values between 98% and 130%, indicating no assay interference—a further validation of the product’s safety profile.
The EFS, which is pending ethics committee approval, is expected to begin patient enrollment and first dosing early this summer. The study will utilize the same batch of gold nanorods that passed the endotoxin screening, reinforcing confidence in the material's clinical readiness.
With its novel biocompatible nanotechnology platform, Sona is pioneering a new generation of targeted medical therapies. This latest development places the company a step closer to clinical validation and eventual commercialization of its proprietary nanomaterials.
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