Pulse Biosciences Treats Initial Patient in Its Human Study Evaluating the Effects of Nano-Pulse Stimulation in Basal Cell
Carcinoma
Study aims to evaluate the cellular destruction and immune response driven by Nano-Pulse Stimulation
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.
Forward-Looking Statements
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.
Investors:
Pulse Biosciences, Inc.
Brian Dow
Sr. Vice President and Chief Financial Officer
IR@pulsebiosciences.com
or
Solebury Trout
Gitanjali Jain Ogawa, 646-378-2949
gogawa@troutgroup.com
or
Media:
Tosk Communications
Nadine D. Tosk, 504-453-8344
nadinepr@gmail.com
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