Sona Nanotech sees 80% response in cancer study

Mr. David Regan reports SONA NANOTECH REPORTS 80% RESPONSE RATE IN FIRST-IN-HUMAN THT CANCER THERAPY STUDY Sona Nanotech Inc. has completed 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 tumours treated with Sona's THT on days one and eight of the study. By day 15, eight out of 10 patients experienced a significant clinical response to treatment with a majority (six out of eight) showing no detectable residual melanoma in representative, biopsied tumours and two patients showing no response. David Regan, Sona's chief executive officer, commented: "These favourable results -- demonstrated in the majority of treated patients -- show that Sona's THT therapy has successfully eliminated melanoma in tumours 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 tumour 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 10 patients experienced responses in a treated tumour with six out of those eight patients' biopsied tumours 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 were 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, Oct. 20, at noon ET to discuss these results in more detail and outline plans for the coming year. Interested parties can register on-line. A recording of the webinar will be made available following the webinar in the investor information section of the company's website. About Sona Nanotech Inc. Sona Nanotech is developing targeted hyperthermia, a photothermal cancer therapy, which uses therapeutic heat to treat solid cancer tumours. The heat is delivered to tumours by infrared light that is absorbed by Sona's gold nanorods in the tumour and re-emitted as heat. Therapeutic heat (42 to 48 degrees Celsius) stimulates the immune system, shrinks tumours, inactivates cancer stem cells and increases tumour perfusion -- thus enabling drugs to reach all tumour 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. We seek Safe Harbor.