Celsion Announces Publication of the Study of ThermoDox® + Ultrasound, “TARDOX Study Protocol” in the Journal of Therape...
November 20 2017 - 8:00AM
Collaboration with University of Oxford to
Execute a Clinical Trial Using Focused Ultrasound and ThermoDox®
for Primary and Metastatic Liver Cancer
Celsion Corporation (NASDAQ:CLSN) today announced publication of
the manuscript, "Clinical trial protocol for TARDOX: a phase I
study to investigate the feasibility of targeted release of
lyso-thermosensitive liposomal doxorubicin (ThermoDox®) using
focused ultrasound in patients with liver tumours," in the Journal
of Therapeutic Ultrasound 2017 5:28.
The article describes the clinical trial design
for the TARDOX Study. This proof of concept study was designed to
demonstrate the safety and feasibility of targeted drug release and
enhanced delivery of doxorubicin from thermally sensitive liposomes
(ThermoDox®) triggered by mild hyperthermia induced by focused
ultrasound in primary and metastatic solid liver tumors.
- The primary outcome measures for the study was the direct
quantification of the doxorubicin concentration before and after
focused ultrasound (FUS) mediated hyperthermia from tumor biopsies,
using high performance liquid chromatography (HPLC).
- The secondary outcome measures for the study relate to the
safety and feasibility of inducing controlled FUS-mediated targeted
hyperthermia in the target tumor non-invasively in order to achieve
ThermoDox® release.
The TARDOX Study, which is supported by the
National Institute for Health Research (NIHR) Oxford Biomedical
Research Centre, was carried out as a multi-disciplinary
collaboration between Celsion, the Oxford University Institute of
Biomedical Engineering (Prof. Constantin Coussios), the Oncology
Clinical Trials Office (OCTO) and the Oxford University Hospitals
NHS Foundation Trust (Prof. Fergus Gleeson, Radiology and Prof.
Mark Middleton, Oncology). The first author is Dr. Paul Lyon
(academic clinical fellow, Oxford University Hospitals NHS
Foundation Trust) and the article is available online in the
November 2, 2017 issue of the Journal of Therapeutic
Ultrasound:
https://jtultrasound.biomedcentral.com/articles/10.1186/s40349-017-0104-0
"Both Celsion and Oxford believe there is
significant potential when combining ThermoDox® with focused
ultrasound to treat a broad range of malignancies, including
primary liver cancer," said Michael H. Tardugno, Celsion's
chairman, president and chief executive officer. "TARDOX, the
ThermoDox®/Focused Ultrasound trial, is an important step in
demonstrating that ultrasound-induced hyperthermia can enable the
highly targeted delivery of chemotherapeutic agents to tumors
non-invasively. This represents another unquestionable example
confirming ThermoDox®’s mechanism of action in a clinical setting
and further establishes that ThermoDox® may be used with multiple
heating technologies allowing for successful targeting of a broad
range of primary and metastatic solid tumors with high
concentrations of chemotherapy."
The Company also announced that an abstract for
the TARDOX Study has been accepted for presentation at the
Radiological Society of North America (RSNA) 2017 Annual Meeting
which will take place from November 26, 2017 – December 1, 2017 at
the McCormick Center in Chicago, IL.
- The abstract, entitled "Clinical Results of a Phase I First in
Man Study of Targeted Delivery of Lyso-thermosensitive Liposomal
Doxorubicin by Extracorporeal Focused-Ultrasound Hyperthermia for
Liver Tumours,” will be presented by Dr. Paul Lyon on Monday,
November 27, 2017 at 11:40 am (local time) during Vascular
Interventional (10-Liver Cancer) Session – Room E352.
- The presentation will summarize clinical findings from all
patients treated in the TARDOX Study, a Phase I clinical study of
ThermoDox®, Celsion's heat-activated liposomal encapsulation of
doxorubicin, in combination with focused ultrasound to treat
primary and metastatic liver cancer.
Professor Constantin-C. Coussios, senior author
and Director of the Institute of Biomedical Engineering at the
University of Oxford, commented, "This clinical program builds upon
many years of experience with ultrasound-guided HIFU, as well as
laboratory studies of ThermoDox® release by ultrasound, at our
institution since 2007. This is the first study in humans to
explore extra corporeally triggered drug release and targeted drug
delivery in oncology. We look forward to exploring the combination
of ThermoDox®, a well-characterized anti-cancer therapy triggered
by heat, with focused ultrasound to cause hyperthermia, rather than
ablation, non-invasively. We are excited by the potential of this
combination to advance treatment within a significantly underserved
population."
About ThermoDox®
Celsion’s most advanced program is a
heat-mediated, tumor-targeting drug delivery technology that
employs a novel heat-sensitive liposome engineered to address a
range of difficult-to-treat cancers. The first application of this
platform is ThermoDox®, a lyso-thermosensitive liposomal
doxorubicin (LTLD), whose novel mechanism of action delivers high
concentrations of doxorubicin to a region targeted with the
application of localized heat at 40°C, just above body temperature.
In one of its most advanced applications, ThermoDox®, when combined
with radiofrequency thermal ablation (RFA), has the potential to
address a range of cancers. For example, RFA in combination with
ThermoDox® has been shown to expand the “treatment zone” with a
margin of highly concentrated chemotherapy when treating individual
primary liver cancer lesions. The goal of this application is to
significantly improve efficacy.
Celsion’s LTLD technology leverages two
mechanisms of tumor biology to deliver higher concentrations of
drug directly to the tumor site. The first: Rapidly growing tumors
have leaky vasculature, which is permeable to liposomes and enables
their accumulation within tumors. Leaky vasculature influences a
number of factors within the tumor, including the access of
therapeutic agents to tumor cells. Administered intravenously, LTLD
is engineered to allow significant accumulation of liposomes at the
tumor site at the time of radiofrequency ablation as these
liposomes recirculate in the blood stream. The second: When the
tumor tissue is heated to a temperature of 40°C or greater, the
heat-sensitive liposome rapidly changes structure and the liposomal
membrane selectively dissolves, creating openings that release the
chemotherapeutic agent directly into the tumor and into the
surrounding vasculature. Drug concentration increases as a function
of the accumulation of liposomes at the tumor site, but only where
the heat is present. This method targets only the tumor and the
area related to tumor invasion, supporting precise drug
targeting.
About Celsion
Corporation
Celsion is a fully-integrated oncology company
focused on developing a portfolio of innovative cancer treatments,
including directed chemotherapies, immunotherapies and RNA- or
DNA-based therapies. The Company's lead program is ThermoDox®, a
proprietary heat-activated liposomal encapsulation of doxorubicin,
currently in Phase III development for the treatment of primary
liver cancer and in Phase II development for the treatment of
recurrent chest wall breast cancer. The pipeline also includes
GEN-1, a DNA-based immunotherapy for the localized treatment of
ovarian and brain cancers. Celsion has two platform technologies
for the development of novel nucleic acid-based immunotherapies and
other anti-cancer DNA or RNA therapies. For more information on
Celsion, visit our website: http://www.celsion.com
(CLSN-LTSL/ThermoDox®)
About the NIHR Oxford Biomedical
Research Centre
The NIHR Oxford Biomedical Research Centre (BRC)
is based at the Oxford University Hospitals NHS Foundation Trust
and run in partnership with the University of Oxford, funded by the
National Institute for Health Research (NIHR).
The NIHR improves the health and wealth of the
nation through research. Established by the Department of Health,
the NIHR:
- funds high quality research to improve health
- trains and supports health researchers
- provides world-class research facilities
- works with the life sciences industry and charities to benefit
all
- involves patients and the public at every step
For further information, visit the NIHR website
www.nihr.ac.uk.
Celsion wishes to inform readers that
forward-looking statements in this release are made pursuant to the
"safe harbor" provisions of the Private Securities Litigation
Reform Act of 1995. Readers are cautioned that such forward-looking
statements involve risks and uncertainties including, without
limitation, 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,
regulatory authorities; and other risks detailed from time to time
in the Celsion's periodic reports and prospectuses filed 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.
Celsion Investor Contact
Jeffrey W. Church Sr. Vice President and CFO 609-482-2455
jchurch@celsion.com
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