Investigator-Sponsored
Research
with ThermoDox
®
Continues
in Multiple Indications
New
Support
for ThermoDox
®
’s
P
otential
from the National Institutes of Health
under a
Cooperative Research and Development Agreement
ZUG, Switzerland, Oct. 11, 2021 (GLOBE NEWSWIRE) — Celsion
GmbH
, a wholly owned subsidiary of
Celsion Corporation
(NASDAQ:
CLSN)
, a clinical-stage biotechnology company focused on DNA-based immunotherapy and next-generation vaccines, announces the journal
Advanced Drug Delivery Reviews
has published an article reviewing the history of ThermoDox
®
, from animal studies through to the Phase III OPTIMA Study in advanced liver cancer
.
Titled “
Drug development of lyso-thermosensitive liposomal doxorubicin: Combining hyperthermia and thermosensitive drug delivery,
” the article was authored by Nicholas Borys, M.D., Executive Vice President and Chief Medical Officer of Celsion, and Mark W. Dewhirst, D.V.M., Ph.D., the Gustavo S. Montana Professor of Radiation Oncology and Vice Director for Basic Science of the Duke Cancer Institute at Duke University School of Medicine, and is available
[here/link].
ThermoDox
®
features a novel mechanism of action that delivers high concentrations of doxorubicin to a region targeted with the application of localized heat at 40°C, just above body temperature. ThermoDox
®
is positioned for use with multiple heating technologies and has the potential to treat a broad range of cancers including metastatic liver, recurrent chest wall breast cancer and non-muscle invading bladder cancers. The article’s authors noted that ThermoDox
®
is the first heat-activated formulation of a liposomal drug carrier to be utilized in human clinical trials.
According to Dr. Borys, “As our recent paper in
Advanced Drug Delivery Reviews
points out there was much learned regarding the application of ThermoDox with heat technology. The publication of this article helps to educate clinical researchers about the compelling results in early-stage studies we have achieved in multiple oncology targets (notably bladder and brain) during our years of work with ThermoDox
®
, which may catalyze further investigation. While Celsion made a business decision to focus the company on other promising programs targeting important indications such as ovarian cancer and infectious diseases, I am pleased that Celsion GmbH will provide support for ThermoDox’s continued clinical evaluation and development. The work that is being initiated with the NIH is exciting and should open new paths of opportunity for ThermoDox.”
Dr. Dewhirst added, “It is good to see important work continuing with ThermoDox
®
. As heat delivery technology continues to improve, such as HIFU (High Intensity Focused Ultrasound), along with the availability of bladder heating technologies there is much potential for ThermoDox in a number of cancers, including the bladder or even the brain. The collaboration between the NIH and Celsion on ThermoDox
®
is an exciting step toward better therapies for patients with cancer.”
Celsion GmbH is also announcing a new Cooperative Research and Development Agreement (CRADA) with the National Institutes of Health (NIH) to evaluate ThermoDox
®
in two
in
vivo
studies:
-
Evaluation of ThermoDox
®
deployment in the rectal mucosa with endorectal heating. This preclinical study in a swine model seeks to explore the feasibility of the maximum tolerated dose of intravenous ThermoDox
®
administration with endorectal heating of mucosa to assess the feasibility, depth of penetration and drug levels in the acute setting. -
Evaluation of ThermoDox
®
deployment in the bladder mucosa with endo-cavitary bladder heating. This preclinical study, also in a swine model, is intended to identify the feasibility of ThermoDox
®
for bladder mucosal delivery utilizing a standard commercial bladder heating devices. To augment standard regimens, intra-cavitary mitomycin C will be co-administered with intravenous ThermoDox
®
, along with heated bladder fluid in a closed circuit, in a regimen that simulates potential future clinical use.
Andreas Voss, M.D., Managing Director of Celsion GmbH, added, “This publication provides a comprehensive summary of the development of ThermoDox
®
to date. While clinical studies in the first indication did not reveal its benefits the powerful proof of concept in vivo provides a strong rationale for the continued clinical development of ThermoDox
®
. The ongoing preclinical and clinical studies will guide us towards clinical indications in which ThermoDox
®
improves patient’s lives.
“In addition, I am highly encouraged by the interest shown to date by independent clinical researchers in investigating ThermoDox
®
. The ability to safely deliver a potent yet toxic chemotherapeutic agent such as doxorubicin warrants such further work to identify the most promising targets. We are delighted the NIH also believes in the potential benefit of this work. While Celsion GmbH’s long-term objective is to seek partnerships to maximize the promise of ThermoDox
®
, our overarching goal is to provide novel treatment options for patients with cancer.”
ThermoDox
®
is currently the subject of investigator-sponsored trials for several cancer indications, including:
-
A Phase I study led by the University Medical Center Utrecht in the Netherlands to determine the safety, tolerability and feasibility of ThermoDox
®
in combination with Magnetic Resonance Guided High Intensity Focused Ultrasound hyperthermia and cyclophosphamide therapy for the local treatment of the primary tumor in metastatic breast cancer. -
A Phase I study led by Oxford University in the UK to assess intravenous delivery of ThermoDox
®
in combination with High Intensity Focused Ultrasound in pancreatic cancer.
About Celsion
GmbH
Celsion GmbH is a wholly owned subsidiary of Celsion Corporation. Based in Zug, Switzerland, its mission is to facilitate investigator-led studies of ThermoDox
®
, including clinical research conducted by the NIH through its Cooperative Research and Development Agreement, maintain relationships with scientists and clinicians and seek opportunities for third party funding. ThermoDox
®
, is a proprietary heat-activated liposomal encapsulation of doxorubicin, is under investigator-sponsored development for several cancer indications. For more information on Celsion GmbH, visit
www.celsiongmbh.com
.
Forward-looking Statements
Forward-looking
statements
in
this
news
release
are
made
pursuant
to
the
“safe
harbor”
provisions
of
the
Private
Securities
Litigation
Reform
Act
of 1995.
These
statements
are
based
upon
current
beliefs,
expectation,
and
assumptions
and
include
statements
regarding
the
platform
having
the
potential
to
provide
broad
protection
against
coronavirus
disease
2019
(COVID-19),
and
possible
future
mutations
of
SARS-CoV-2
or
other
coronaviruses.
These
statements
are
subject
to
a
number
of
risks
and
uncertainties,
many
of
which
are
difficult
to
predict,
including
the
ability
of
the
Company’s
platform
to
provide
broad
protection
against
COVID-19,
and
possible
future
mutations
of
SARS-CoV-2
or
other
coronaviruses,
the
issuance
of
a
patent
to
the
Company
for
use
of
its
technology
platform
for
treating
or
preventing
infection
with
the
SARS-CoV-2
virus
that
causes
COVID-19,
unforeseen
changes
in
the
course
of
research
and
development
activities
and
in
clinical
trials;
the
uncertainties
of
and
difficulties
in
analyzing
interim
clinical
data,
particularly
in
small
subgroups
that
are
not
statistically
significant;
FDA
and
regulatory
uncertainties
and
risks;
the
significant
expense,
time
and
risk
of
failure
of
conducting
clinical
trials;
the
need
for
Celsion
to
evaluate
its
future
development
plans;
possible acquisitions
or
licenses
of
other
technologies,
assets
or
businesses;
possible
actions
by
customers,
suppliers,
competitors
or
regulatory
authorities;
and
other
risks
detailed
from
time
to
time
in
the
Celsion’s
periodic
filings
with
the
Securities
and
Exchange
Commission.
Celsion
assumes
no
obligation to update
or supplement
forward-looking
statements that
become untrue because
of
subsequent events,
new
information
or
otherwise.
LHA Investor Relations
Kim Sutton Golodetz 212-838-3777
[email protected]
# # #
