The first patient has been treated in a clinical study to evaluate Nano-Pulse Stimulation (NPS) from Pulse Biosciences, Inc. for the treatment of Basal Cell Carcinoma (BCC). NPS is a non-thermal therapy that utilizes ultra-short, nanosecond pulsed electric fields that directly affect and disrupt intracellular structures and have been shown to induce immunogenic cell death in pre-clinical cancer models.

Patients in the study will be treated with NPS prior to resection of the BCC lesion, which is the standard of care for BCC lesions. Post resection tissue samples will be assessed for elimination of the BCC lesion in the NPS treatment zone and for biomarkers indicating an immune response to the NPS-treated BCC lesions.
Four leading skin cancer surgery centers in the United States will participate in this multi-center trial, scheduled to enroll up to 75 patients with biopsy-confirmed BCC lesions that will be treated and subsequently excised at the conclusion of the study. Both tissue and blood samples will be evaluated to characterize BCC elimination and changes in the immune response. A control group will be treated with standard cryoablation treatment, commonly known as cryotherapy, and will serve as a comparison between NPS and this commonly used method of benign and non-benign tissue destruction.
“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,” said Thomas Rohrer, MD, of Skin Care Physicians of Chestnut Hill, MA, one of the principal investigators in the study. “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.”
The purpose of the “treat and resect” human clinical study in BCC is to take an important first step in evaluating NPS’ treatment effect on cancerous tumor cells in a human skin cancer. This unique BCC study design provides the opportunity to obtain important NPS tissue and immune response data. The study is expected to complete enrollment by year-end 2018.
“We are pleased to be working with Pulse Biosciences to investigate its NPS technology in BCC, which is a skin cancer with a high mutational burden,” said Robert H. Pierce, MD, Scientific Director of the immunopathology Lab at the Fred Hutchinson Cancer Research Center in Seattle, WA. “This project will leverage Fred Hutchison’s expertise and capabilities in translational oncology to assess the ability of NPS to effectively eliminate the tumor and to increase tumor infiltrating lymphocytes.”