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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20180730005780/en/
Investors:Pulse Biosciences, Inc.Brian DowSr. Vice
President and Chief Financial
OfficerIR@pulsebiosciences.comorSolebury TroutGitanjali Jain Ogawa,
646-378-2949gogawa@troutgroup.comorMedia:Tosk
CommunicationsNadine D. Tosk, 504-453-8344nadinepr@gmail.com
Pulse Biosciences (NASDAQ:PLSE)
Historical Stock Chart
From Apr 2024 to May 2024
Pulse Biosciences (NASDAQ:PLSE)
Historical Stock Chart
From May 2023 to May 2024