The Company was provided with data from the Study that indicates the response in a pre-clinical triple negative breast cancer model treated with the combination of Sona's targeted hyperthermia therapy ('THT') and interleukin-2 ('IL-2'), a standard immunotherapy, is statistically significantly superior to results observed from treatment with either agent individually or the control group. This second phase of the Study has documented that, in a cohort of six animals, 6/6 of treated triple negative breast cancer, the most aggressive and therapy resistant form, mouse tumors bearing gold nanorods and IL-2 responded to the combination therapy, resulting in a flattening of the tumor growth curves, as shown in the below graph. The generation of hyperthermia involved exposing tumors previously injected intratumorally with Sona's gold nanorods and IL-2 to a single dose of near infrared light.
In these encouraging initial results, Sona's THT therapy appears to cause cancer cell death in this pre-clinical mouse model, changing the tumor microenvironment and initiating novel, and more effective, tumor-specific immunity.'
Sona CEO,
The Study's next step is to assess the therapy's ability to generate similar results in melanoma and colorectal cancer mouse models and determine the extent to which it serves as an immune modulator for distant, untreated tumors in these cancers. Next, regulatory permission to conduct human trials requires certain satisfactory pre-clinical safety and biocompatibility studies, amongst other potential work. The Company has received guidance on its pre-clinical study plan from both the
The results discussed in this release are preliminary and have not been subject to peer review. Upon completion, the Company expects that the full Study will be submitted for peer review and scientific journal publication.
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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.
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 of Targeted Hyperthermia Therapy, the Dalhousie study, future publication of study results, Sona's preclinical study plans, the potential impact of the planned studies and its product development 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 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.
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