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Sona Nanotech Inc. (CSE: SONA,OTC:SNANF) (OTCQB: SNANF) (the "Company", "Sona"), is pleased to provide follow-up histology tissue analysis data from its first-in-human early feasibility study of its Targeted Hyperthermia Therapy ('THT') in late stage melanoma patients who had failed on standard immunotherapy protocols (the "Study"). An extensive multiplex histological tissue analysis conducted at Dalhousie University of representative tissues from Study patients showed extensive natural killer cell infiltration in tumor tissues biopsied after treatment with THT indicative of innate immune activation. Also, analysis of samples from Study patients who only partially responded to the THT treatment showed a significant increase in T-regulatory cells and strong PD-L1 expression suggesting that these tumors may benefit from adding PD-1 immunotherapy in combination with Sona's THT treatment.
Dr. Carman Giacomantonio, Sona's CMO, commented, "We are very proud and excited to report that the detailed histological tissue analysis from representative patient samples validates our pre-clinical findings. Our analysis confirms that patients responding to Sona's THT treatment experienced a strong immunogenic response characterized by extensive innate immune activation with abundant macrophage infiltration and a robust natural killer cell infiltration. Notably, in partially responding patients, we observed a significant increase in T-regulatory cells and strong expression of PD-L1. The significance of this in response is these patients would be predicted to respond to PD-1 and CTLA-4 immunotherapy, particularly if administered in timely combination with our THT."
These results, together with our pre-clinical modelling studies, give us great confidence that immunotherapy response rates, which are typically below 20% for colorectal cancer, can be increased by first priming tumors with Sona's THT therapy before administering immunotherapy, giving hope to the four out of five colorectal cancer sufferers for whom no treatment tends to work.".
This histology tissue analysis, together with the Study's protocol and other findings are now being prepared for submission to a scientific journal for peer review and publication.
In the Study, ten advanced-stage melanoma patients, all of whom were failing to respond to standard immunotherapy treatment, were recruited into this early feasibility study. Under the study protocol, patients had up to four tumors treated with Sona's THT on days one and eight of the Study. By day 15, 8/10 patients experienced a clinical response to the THT treatment with a majority (6/8) showing no detectable residual melanoma in representative, biopsied tumors, with two patients showing no response.
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 secure the remaining required regulatory approvals for the Pilot Study, enroll study participants in a timely manner, 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.
SOURCE Sona Nanotech Inc.
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