Mr. David Regan reports
FIRST PATIENT DOSED IN EARLY FEASIBILITY STUDY TRIAL OF ITS CANCER THERAPY
Sona Nanotech Inc. has achieved a first dosing in the previously announced early feasibility study of its targeted hyperthermia therapy cancer treatment.
Dr. Carman Giacomantonio, Sona's chief medical officer, commented: "Our unique therapy aims to modify tumours, making them more visible to the immune system, with a view to enabling an elimination of the cancer. As with any new technology, we are required to demonstrate that we can safely and feasibly deliver the treatment in the clinical setting. We have smartly designed this inaugural study to also provide us with some key, first ever reported insights into its effect in human cancer. Success in this study will enable us to proceed to our next planned study that will more critically evaluate the biological effects and clinical outcomes of this exciting technology."
David Regan, chief executive officer, commented: "Getting to this first dosing of a patient with our targeted hyperthermia therapy is a milestone achieved through the culmination of years of research, toil and many preclinical studies. We plan to follow this critical first clinical step quickly with a second, more expansive human trial following further engagement with regulators, as well as a peer-reviewed article in a leading scientific journal detailing our findings. We also expect the learnings from this study to help inform on THT's potential for complementing the treatment of other cancer types."
About the study
The study is designed to assess THT's safety, tolerability and preliminary efficacy as measured by tumour growth inhibition and the extent to which it causes immune system engagement with the cancer. The study includes two treatments of Sona's THT, one week apart, for patients with advanced melanoma who are, or have been on, standard of care immunotherapy protocols but have failed to respond or progressed during treatment. The study is anticipated to generate an initial readout of results this summer, with final results expected in the fall.
Technology will be evaluated for:
- Ease of setting up and preparation for the treatment;
- Ease of administration of GNRs in a variety of different tumours;
- Reproducibility in the clinical setting -- that is, the ability to train others to use the technology;
- Resource requirements -- that is, what additional resources are required in the clinical setting;
- Time required to administer the treatment in the clinical setting.
Participants will be evaluated for:
- Tolerability to the treatment itself;
- Adverse events during and following treatment;
- Clinical response -- that is, did the tumour change in any way after treatment?
- Pathological immune response -- that is, histological evidence of immune activation in the tumour that is directly relatable to the treatment itself.
Sona Nanotech believes that its THT cancer treatment may provide benefits over current standard of care immunotherapy treatments alone, which have shown limited response rates and can have undesirable side effects.
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 C) 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. Sona Nanotech's gold nanorod particles are cetyltrimethylammonium free, eliminating the toxicity risks associated with the use of other gold nanorod technologies in medical applications.
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