Celsion Announces Collaboration with the Children’s Research Institute to Evaluate the Use of ThermoDox® and High Intensit...
October 11 2016 - 8:00AM
First Ever Clinical Trial in Children
Using a Targeted Chemotherapeutic Drug Released by Focused
Ultrasound Expected to Commence in Q4 2016
Celsion Corporation (NASDAQ:CLSN), a leading oncology drug
development company, today announced a collaboration with the
Children’s Research Institute to conduct a clinical study of
ThermoDox®, Celsion’s heat activated liposomal encapsulation of
doxorubicin, in combination with magnetic resonance-guided high
intensity focused ultrasound (MR-HIFU) to treat relapsed or
refractory solid tumors in children and young adults. This
investigator-sponsored Phase I clinical study is being partially
funded by the National Institutes of Health and is expected to
commence in the fourth quarter of 2016.
“Even with the use of intensive therapy, the
prognosis for children diagnosed with metastatic sarcoma and
recurrent solid tumors remains poor and has not improved over the
past three decades,” stated Dr. Nicolas Borys, Celsion’s chief
medical officer. “Recent advances in the use of non-invasive
MR-HIFU coupled with novel therapies such as ThermoDox® have
demonstrated the clear potential to overcome the challenges to
treating pediatric malignancies by enabling safer, more tolerable
targeted therapies with the potential to change cancer treatment
paradigms.”
The trial targeting treatment of childhood
sarcomas will be carried out as a multi-disciplinary collaboration
among Celsion, the research groups of Dr. AeRang Kim, MD, PhD at
the Children’s National Medical Center – Department of
Hematology/Oncology, and Dr. Brad Wood and Dr. Rosandra Kaplan at
the National Institutes of Health.
"Celsion’s experience in combining ThermoDox®
with HIFU, a non-invasive next generation heating technology,
supports this very important research in childhood cancers.
From a safe dose, ThermoDox’s proven ability to deliver high
concentrations of an effective chemotherapy directly to a heated
tumor makes it an ideal candidate for a trial involving children
and young adults," said Michael H. Tardugno, Celsion's chairman,
president and chief executive officer. "This study will
further define ThermoDox’s potential in combination with
ultrasound-induced hyperthermia, and highlight potential
applications of ThermoDox® in combination with a broad range of
heating technologies that could address an even larger population
of patients."
ThermoDox® is currently in late stage clinical
trials in primary liver cancer and recurrent chest wall breast
cancer. It is positioned for use with multiple heating
technologies, and has the potential for applications in the
treatment of other forms of cancer including metastatic liver and
non-muscle invading bladder cancers.
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.
ThermoDox® has the potential to address a broad range of
cancers.
Celsion's LTLD technology leverages two
mechanisms of tumor biology to deliver higher concentrations of
drug directly to the tumor site. In the first mechanism, 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, ThermoDox® is engineered with a
half-life to allow significant accumulation of liposomes at the
tumor site as these liposomes recirculate in the blood stream.
In the second mechanism, when an external heating device
heats tumor tissue to a temperature of 40°C or greater, the
heat-sensitive liposome rapidly changes structure and the liposomal
membrane selectively dissolves, creating openings that can release
a 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 damages only the tumor and the
area related to tumor invasion, supporting more 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 anticancer DNA or RNA therapies, including TheraPlas™ and
TheraSilence™. The Company has a Cooperative Research and
Development Agreement (CRADA) with the NIH. Any reference to
NIH should not be viewed as an endorsement of Celsion, its products
or services.
For more information on Celsion, visit our
website: http://www.celsion.com. (LTSL/ThermoDox®)
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 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
Celsion Media Contacts
Harriet Shelare
Director, Communications
860-483-1721
hshelare@celsion.com
Bill Berry
Berry & Company
212-253-8881
bberry@berrypr.com
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