Celsion GmbH Announces the Publication of an Article Reviewing the History of ThermoDox® Drug Development in Advanced Drug Delivery Reviews
October 11 2021 - 9:00AM
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 RelationsKim
Sutton Golodetz 212-838-3777kgolodetz@lhai.com
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