Sona Nanotech Receives Technology Assessment Results from NCL
Halifax, Nova Scotia – Newsfile Corp. – February 8, 2023 – Sona Nanotech Inc. (CSE: SONA) (OTCQB: SNANF) (the “Company” or “Sona”) is pleased to announce that it has received the results of an independent assessment of its proprietary gold nanorod nanoparticles from the National Cancer Institute’s Nanotechnology Characterization Laboratory (“NCL”). The assessment included analyses of three batches of Sona’s materials for microbial contamination, endotoxin levels, Beta-glucan, physiochemical characterization, and polyethylene glycol (“PEG”) concentrations.
“The results of the NCL’s characterization of Sona’s biocompatible gold nanorod nanoparticles indicate that they are expected to be compatible for use in vivo with Siva’s Targeted Hyperthermia Therapy, as ruling out the material presence of endotoxins was key to enabling our further work together towards preparations for clinical trials,” Sona’s CEO, David Regan and Siva Therapeutic’s CEO, Len Pagliaro, Ph.D. jointly commented.
The analyses determined that endotoxins and microbial contamination were “undetectable” based on both turbidity and chromogenic limulus amebocyte lysate (“LAL”) assays and the NCL’s endotoxin limit. While beta-glucan levels varied across the samples, they were all within limits of what is normally present in the blood from dietary sources. Also, no free PEG was detected in any of the three batches of materials provided.
The NCL will continue to work with Siva and Sona to conduct further studies that are anticipated to be required to support any submission for the use of Sona’s gold nanorods in Siva’s Targeted Hyperthermia Therapy to the US Food and Drug Administration (“FDA”), including a quantitation of the surfactant detected in the samples. The NCL was established by the National Cancer Institute (“NCI”) to accelerate the progress of nanomedicine by providing preclinical characterization and safety testing of nanoparticles. The NCL is a collaborative effort between NCI, the FDA, and the National Institute of Standards and Technology (“NIST”).
As announced on January 26, 2023, Sona entered into a binding agreement to acquire Siva Therapeutics, the developer of Targeted Hyperthermia Therapy™ (“THT”) photo thermal therapy for cancer tumors using Sona’s uniquely biocompatible gold nanorods (the “Proposed Transaction”). The completion of the Proposed Transaction is subject to the satisfaction of a number of closing conditions, including the closing of an equity raise for up to $500,000 at $0.10 per share and one for gross proceeds of at least US $1.0 million, or any other amount that is mutually agreed by the Parties.
Siva’s THT path to market will involve the completion of large animal studies and the filing for an Investigational Device Exemption (“IDE”) with the FDA in preparation for human clinical studies. Siva’s management team has over 50 years of combined life sciences and medical device experience with a track record of prior successful market introductions.