The study intends to assess the cellular destruction and immune response driven by NPS, a non-thermal, precise, focal tissue treatment technology comprised of nanosecond range pulsed electric fields that directly affect the cell membrane and intracellular structures and initiate cell death in treated cells.
Patients in the study will be treated with NPS before resection of the BCC lesion, which is the standard care for BCC lesions.
Post resection, tissue samples will be assessed for elimination of BCC lesion in the NPS treatment zone and for biomarkers that indicate immune response of BCC lesions to the NPS-treatment.
Four skin cancer surgery centers in the US will participate in the multi-center trial. They will enroll up to 75 patients with biopsy-confirmed BCC lesions.
Both tissue and blood samples will be assessed to characterize BCC elimination and changes in the immune response.
The control group will be treated with standard cryoablation treatment also known as cryotherapy and will be used for comparison between NPS and the commonly used method of benign and non-benign tissue destruction.
Skin Care Physicians of Chestnut Hill and one of the principal investigators in the study Thomas Rohrer said: “As a skin cancer specialist, I perform hundreds of surgical excisions of skin cancers every year and am very excited about this initial study to assess the potential of NPS in Basal Cell Carcinoma.
“I am intrigued about the potential of NPS to both directly eliminate treated basal cells and, importantly, to stimulate the immune system. Demonstrating this type of immunogenic response in BCCs may also provide important insights for treating other types of cancers.”
Pulse Biosciences stated that the purpose of the ‘treat and resect’ human clinical study in BCC is to take the first step in the evaluation of NPS treatment’s effect on cancerous tumor cells in human skin cancer.
The BCC study design offers the opportunity to obtain important NPS tissue and immune response data. The study is expected to complete enrollment by the end of this year.
Pulse Biosciences president and CEO Darrin Uecker said: “We are excited to commence the first of what we expect to be multiple clinical studies in immuno-oncology using Nano-Pulse Stimulation with such a highly regarded group of clinicians and scientists.
“Data from this study, including evidence of BCC cellular destruction and immune response changes as a result of NPS, will be important in assessing NPS in BCC, which represents a significant opportunity, and, potentially, in other applications.”
