Fourth Dermatology Study Will Evaluate Nano-Pulse Stimulation™in Treating Cutaneous Warts
Nano-Pulse Stimulation Clinical Studies in Treating Sebaceous
Hyperplasia (SH) and Basal Cell Carcinoma Continue to Make Progress,
Strong Interim SH Results
Dr. George Hruza to Present Seborrheic Keratoses Data at the 2018
American Society for Dermatologic Surgery Annual Meeting in Phoenix on
Friday, October 12, 2018
HAYWARD, Calif.--(BUSINESS WIRE)--Oct. 11, 2018--
Pulse Biosciences, Inc. (Nasdaq: PLSE) today announced the initiation of
a clinical feasibility study using its novel Nano-Pulse Stimulation™
(NPS™) platform to treat patients with cutaneous warts. The initiation
of this feasibility study reflects the Company’s continued efforts to
develop a portfolio of dermatologic applications building on the success
of recently completed and ongoing clinical studies.
Nano-Pulse Stimulation is a novel, precise non-thermal treatment
technology delivering nanosecond duration energy pulses that impact
cells in treated tissue while sparing surrounding acellular tissue. With
its broadly applicable cell-targeting mechanism, NPS disrupts the
functions of internal cell structures while maintaining the outer cell
membrane. The unique NPS mechanism of action has been shown in previous
clinical studies to eliminate treated cells with mild inflammatory
response that results in favorable healing and cosmetic outcomes, making
NPS well suited for a broad range of skin lesions.
Cutaneous wartsare benign grainy skin growths that are typically
caused by the human papillomavirus (HPV). According to an updated 2018
published article, 22.8 million patients per year suffer from warts (https://emedicine.medscape.com/article/1133317).
This feasibility study will include up to 20 subjects at the prestigious
Scripps Clinic in San Diego, CA. Eligible subjects receive NPS
treatment(s) followed by evaluations at 7-days, 30-days, and 60-days
post-initial NPS treatment. Patient enrollment, treatment and follow-up
are expected to be completed during the first quarter of 2019.
“Although common warts are a widespread skin condition that every
dermatologist sees regularly, we do not have reliable solutions to offer
our patients,” said E. Victor Ross, M.D., principal investigator and
leading dermatologic surgeon at Scripps Clinic, San Diego, who is
initiating the first patient treatments. “The unique non-thermal
mechanism of NPS has been shown to affect deeper cellular structures
without damaging the adjacent dermis. Our hope is that NPS treatment can
reach and eliminate these deeper warts with better efficacy and without
as much collateral tissue damage as thermal methods like laser heating
or cryogen freezing of the tissue.”
The clinical study announced today is one of several clinical programs
underway to evaluate Pulse Biosciences’ proprietary Nano-Pulse
Stimulation therapy. Beyond the initiation of the warts feasibility
study, Pulse’s clinical programs continue to advance:
- NPS for the treatment of Sebaceous Hyperplasia (SH). A
multi-center study to evaluate the safety and efficacy of Nano-Pulse
Stimulation for the treatment of Sebaceous Hyperplasia, a common but
difficult-to-treat facial lesion. The study has fully enrolled, and
all patient NPS treatments have been completed. Data on the first 79
treated lesions (approximately 35% of study total) that have reached
the final 60-day post-treatment evaluation show lesion efficacy
greater than 95%. Data collection and analysis is on schedule to be
completed during the fourth quarter of 2018. (NCT03612570)
- NPS Basal Cell Carcinoma (BCC) Biomarker Study. A multi-center
“treat and resect” study evaluating local lesion affect and immune
response changes to NPS. Direct evidence of basal cell elimination as
well as immunologic biomarker data are being collected and analyzed in
collaboration with the Fred Hutchinson Cancer Research Center. Study
completion is slated for year-end 2018 with data to be reported during
the first quarter of 2019.
Dr. George Hruza, a research leader in dermatologic and Mohs surgery in
St. Louis, MO, will present his positive results of a data subset
demonstrating 93% clinical efficacy rate for clearing of Seborrheic
Keratoses lesions with a single treatment of non-thermal NPS. The full
dataset was presented at the 2018 American Society of Lasers, Medicine
and Surgery in April. His presentation will take place on Friday,
October 12, 2018 at the American
Society for Dermatologic Surgery (ASDS) Annual Meeting in Phoenix.
“We’re pleased with the clinical progress we’re making in dermatology as
we drive towards commercialization in this exciting market,” said Darrin
Uecker, Pulse Biosciences’ President and Chief Executive Officer. “We
continue to demonstrate safety and efficacy in compelling dermatologic
indications that also provide proof of the NPS mechanism in support of
future indications in both benign and non-benign conditions.”
About Pulse Biosciences and Nano-Pulse Stimulation
Pulse Biosciences is a novel medical therapy company bringing to market
its proprietary Nano-Pulse Stimulation™ (“NPS™”) platform. NPS is a
novel, precise, non-thermal, treatment technology delivering nanosecond
duration energy pulses that impact cells in treated tissue while sparing
surrounding acellular tissue. NPS’s unique mechanism of action disrupts
the functions of internal cell structures while maintaining the outer
cell membrane initiating a cascade of events within the cell that
results in regulated cell death. In pre-clinical studies, NPS has
demonstrated an ability to induce immunogenic cell death in cancer cell
lines. The novel characteristics of NPS’s unique mechanism of action has
the potential to significantly benefit patients for multiple medical
applications, including dermatology, the Company’s first planned
commercial application, with future potential in other disease states
where an enhanced immune response may be beneficial. More information is
available at http://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/20181011005259/en/
Source: Pulse Biosciences, Inc.
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
