First Patients Expected to be Enrolled This Month
The study's principal investigator and Bradford Hill executive director, Dr. Carlos Rojas, commented, "With extensive experience in conducting clinical trials in melanoma for tier-one global pharmaceutical companies, we are excited to partner with Sona Nanotech to assess the potential for their novel cancer treatment with patients in Chile."
Sona CMO, Dr. Carman Giacomantonio, commented, "As an early feasibility study, the primary data to be gathered from this study are for the safety and tolerability of THT in human subjects. We will also look to assess preliminary efficacy as determined by whether each patient's immune system is engaged by Sona's THT treatment. Indicators of success will include findings of tumor cell death in tumors treated with THT and evidence of associated enhanced immunity in these patients."
The study is designed to assess safety, tolerability, and preliminary efficacy and will include two treatments of Sona's THT, one week apart, for patients with advanced melanoma who are on but have failed to respond to a standard of care immunotherapy protocol. The study is subject to final ethics committee approval, and enrollment of the first patients is anticipated by the end of June with interim results this summer and final results expected this fall.
Sona Nanotech believes that its THT treatment may provide benefits over current standard of care immunotherapy treatments alone which have shown limited response rates and can have undesirable side effects.
Contact:
David Regan, CEO
+1-902-442-0653
david@sonanano.com
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 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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