Pulse Biosciences, Inc. (Nasdaq:PLSE) has begun a clinical study to evaluate nano-pulse stimulation (NPS) platform in a common skin cancer, basal cell carcinoma (BCC).
NPS is a non-thermal therapy that uses ultra-short, nanosecond-pulsed electric fields that directly affect and disrupt intracellular structures. It has been shown to induce immunogenic cell death in pre-clinical cancer models, according to the company.
Study participants will be treated with NPS prior to resection of the BCC lesion, which is the standard of care for such lesions. Post-resection tissue samples will be assessed for the elimination of the lesion in the NPS treatment zone and for biomarkers indicating an immune response to the NPS-treated lesions.
The Hayward, Calif. startup withdrew the FDA 510(k) application for its PulseTx NPS system on September 11, 2017, saying it failed to meet a deadline for submitting requested information to the agency. The company has said it intends to refile.
Two weeks later, Pulse announced it would sell 2 million shares of common stock at $15.02 apiece to investor Robert Duggan in a $30 million private placement. The Securities and Exchange Commission is now investigating alleged insider trading in advance of that financing announcement. The company has said it is fully cooperating with the investigation.
Four 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 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, Mass., one of the principal investigators in the study, in a statement from Pulse Biosciences (Hayward, Calif.). “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 the first step in evaluating NPS’ treatment effect on cancerous tumor cells in a human skin cancer. The 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 and complete data follow-up in the first quarter of 2019.
Basal cell carcinoma is a skin cancer with a high mutational burden, according to Robert Pierce, MD, scientific director of the immunopathology lab at the Fred Hutchinson Cancer Research Center in Seattle, Wash. “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.”
Pulse Biosciences, which is pre-revenue, posted a loss of -$9.2 million for the three months ended June 30, up 48.4% compared with Q2 2017. PLSE shares were up 4.6% to $13.97 apiece today in early trading.