HAYWARD, Calif.--(BUSINESS WIRE)--Pulse Biosciences, Inc. (Nasdaq: PLSE) today announced the treatment of the first patient in a clinical study to evaluate Nano-Pulse Stimulation (NPS) in a common skin cancer, Basal Cell Carcinoma (BCC). 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. 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.
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, M.D., 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.”
About the BCC Study
Pulse Biosciences expects patient enrollment during the second half of 2018 to achieve its goal of 75 enrolled patients by the end of 2018 and complete data follow-up in Q1 2019. Principal investigators of the BCC NPS study include the following dermatologic surgeons that specialize in surgical removal of skin cancers (Mohs Surgeons): Dr. Christopher Harmon in Birmingham, AL; Dr. Gilly Munavalli in Charlotte, NC; Dr. Thomas Rohrer in Boston, MA; and Dr. Brian Zelickson in Minneapolis, MN. In addition to Dr. Pierce, who will serve as an independent immuno-oncology specialist, Dr. Darius R. Mehregan, Director of the Pinkus Dermatopathology Lab in Detroit, MI will serve as an independent dermatopathologist.
“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,” said Darrin Uecker, President and Chief Executive Officer of Pulse Biosciences. “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.”
About Pulse Biosciences and Nano-Pulse Stimulation
Pulse Biosciences is a publicly listed clinical stage electroceutical company pursuing multiple clinical applications of its proprietary Nano-Pulse Stimulation technology. Nano-Pulse Stimulation (NPS) is a non-thermal, precise, focal tissue treatment technology comprised of nanosecond (billionth of a second) range pulsed electric fields that directly affect the cell membrane and intracellular structures and initiate cell death in treated cells. The initiation of cell death by NPS results in a minimal inflammatory response, which improves healing outcomes and supports the replacement of treated tissue cells with healthy tissue cells. NPS’ unique mechanism of action to initiate cell death has the potential to significantly benefit patients for multiple medical applications in dermatology, immune-oncology, and in other unique tissue targets. In cancerous lesions, NPS has been shown in preclinical models to induce immunogenic cell death (ICD), which exposes the unique antigens of the treated cells to the immune system and enrolls immune system cells, such as cytotoxic T-cells to mount an adaptive immune response. More information is available at www.pulsebiosciences.com.
All statements in this press release that are not historical are forward-looking statements, including, among other things, statements relating to Pulse Biosciences’ expectations regarding the mechanism of action of NPS treatments, current and planned future clinical studies, other matters related to its pipeline of product candidates, future financial performance, regulatory clearance and the timing of FDA filings or approvals, and other future events. These statements are not historical facts but rather are based on Pulse Biosciences’ current expectations, estimates, and projections regarding Pulse Biosciences’ business, operations and other similar or related factors. Words such as “may,” “will,” “could,” “would,” “should,” “anticipate,” “predict,” “potential,” “continue,” “expects,” “intends,” “plans,” “projects,” “believes,” “estimates,” and other similar or related expressions are used to identify these forward-looking statements, although not all forward-looking statements contain these words. You should not place undue reliance on forward-looking statements because they involve known and unknown risks, uncertainties, and assumptions that are difficult or impossible to predict and, in some cases, beyond Pulse Biosciences’ control. Actual results may differ materially from those in the forward-looking statements as a result of a number of factors, including those described in Pulse Biosciences’ filings with the Securities and Exchange Commission. Pulse Biosciences undertakes no obligation to revise or update information in this release to reflect events or circumstances in the future, even if new information becomes available.
Caution: Pulse Biosciences’ Nano-Pulse Stimulation (NPS) is an investigational use therapy.