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-- Six out of ten patients experienced complete responses in treated tumors with an additional two patients demonstrating partial responses - confirmed in a representative tumor biopsy - all within two weeks of initial treatment --
Sona Nanotech Inc., (CSE: SONA,OTC:SNANF) (OTCQB: SNANF) (the "Company", "Sona"), is pleased to announce the completion of its first-in-human clinical study treating patients with histologically confirmed, immunotherapy-resistant cutaneous metastatic melanoma using Sona's Targeted Hyperthermia Therapy ("THT"). Ten advanced-stage 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, 810 patients experienced a significant clinical response to treatment with a majority (68) showing no detectable residual melanoma in representative, biopsied tumors, and two patients showing no response.
David Regan, Sona's CEO, commented, "These favorable results—demonstrated in the majority of treated patients—show that Sona's THT therapy has successfully eliminated melanoma in tumors where leading treatments had previously failed. This outcome has exceeded our expectations and delivered on our commitment to investors to produce human efficacy data quickly. Based on findings from this study, we are preparing for a Canadian clinical trial that will provide deeper insights into the biological potential of our THT as we prepare to expand its clinical application into a broader range of solid tumor cancers. An application for an investigational testing authorization ("ITA") has been made to Health Canada to permit this next clinical study for which we have already received research ethics board approval."
The study's principal investigator, Dr. Carlos Rojas, Executive Director of the Bradford Hill Clinical Cancer Research Center commented, "We were very impressed by the rapid and measurable responses observed in patients who had exhausted standard immunotherapy options. These outcomes have provided meaningful hope for the patients enrolled."
Dr. Carman Giacomantonio, Sona's CMO, commented, "These tremendous results validate our earlier, published preclinical findings and provide compelling clinical evidence of the efficacy and tolerability of Sona's novel Targeted Hyperthermia Therapy in human cancer. Although this study was not powered to determine response rates, eight out of ten patients experienced responses in a treated tumor with six out of those eight patients' biopsied tumors showing a complete response — commands one's attention. Equally impressive is the observation that these responses were confirmed after only two weeks from the initial treatment. This, to my knowledge, is unprecedented."
Safety and tolerability data also showed favourable results. One stage IV patient reported a serious adverse event during the trial that investigators determined to be unrelated to THT, which ultimately resolved. Also, two stage IV patients expired shortly following completion of the study period due to distant disease progression. Another aim of the study was to capture clinician-reported and patient-reported experience with the physical delivery of THT with a view to improving the overall clinical delivery of Sona's THT. To this end, significant data was captured highlighting opportunities for design and application enhancement that will be applied and evaluated in future studies.
The Company also announces that its Chief Scientific Officer, Len Pagliaro, PhD., is stepping back from an operational role. "Developing a powerful but gentle cancer therapy that uses nanotechnology to stimulate the immune system, and has the potential to transform lives, has been the focus of the past 16 years of my career," said Dr. Pagliaro. "These remarkable first-in-human results mark the fulfillment of that vision. I now look forward to continuing to support the Company as a member of Sona's board of directors."
Investor Webinar details:
The Company is also pleased to announce that it will host a webinar on Monday, October 20th at noon EST to discuss these results in more detail and outline plans for the coming year. Interested parties can register here: http://bit.ly/3JcFls5. A recording of the webinar will be made available following the webinar in the Investor Information section of the Company's website.
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, impact and effectiveness of Sona's THT cancer treatment, the timing and receipt of expected positive histological results supporting first-in-man treatment results obtained to date, potential future applications of Sona's THT cancer treatment, the timing and completion of Sona's proposed Canadian pilot study 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 reported and 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.
Not for distribution to United States newswire services or for dissemination in the United States
To view the source version of this press release, please visit https://www.newsfilecorp.com/release/271025
