Celsion Corporation Announces Presentation of Results from Independent NIH Analysis of ThermoDox® plus Optimized RFA for the...
November 29 2016 - 8:00AM
NIH Analysis of Data from Celsion’s HEAT Study
Reaffirms Correlation Between Increased RFA Burn Time per Tumor
Volume and Significant Improvements in Overall Survival
Celsion Corporation (NASDAQ:CLSN) today announced the
presentation of results from an independent retrospective analysis
conducted by the National Institutes of Health (NIH) on the
intent-to-treat population of the Company’s HEAT Study, a
701-patient study of ThermoDox®, Celsion's proprietary
heat-activated liposomal encapsulation of doxorubicin in
combination with radiofrequency ablation (RFA) in primary liver
cancer, also known as hepatocellular carcinoma (HCC). The findings
of the NIH study were presented during The Interventional Oncology
Series: Hepatocellular Carcinoma and Cholangiocarcinoma at the
102nd Scientific Assembly and Annual Meeting of the Radiological
Society of North America (RSNA) on Monday, November 28, 2016 from
1:00 pm to 6:00 pm CT and was moderated by Professor Riccardo
Lencioni, lead European Investigator on Celsion’s HEAT Study.
Celsion is currently studying the use of RFA as a heat source both
for tumor ablation and to activate ThermoDox® as a means of
affecting the area surrounding the tumor, where later recurrence
most often takes place.
The NIH analysis was conducted under the
direction of Dr. Bradford Wood, MD, Director, NIH Center for
Interventional Oncology and Chief, NIH Clinical Center
Interventional Radiology. The NIH analysis, which sought to
evaluate the correlation between RFA burn time per tumor volume
(min/ml) and clinical outcome, concluded that increased burn time
per tumor volume significantly improved overall survival (OS) in
patients with solitary lesions treated with RFA + ThermoDox®
compared to patients treated with RFA alone. More
specifically, the analysis showed that a one unit increase in RFA
duration per tumor volume improved OS by 20% in patients treated
with optimized RFA + ThermoDox® compared to RFA alone.
This novel way of assessing the impact of the
drug takes into account both the size of the tumor and the time of
ablation, both of which appear to be important factors. The
NIH analysis included 437 patients with a single lesion from the
Company’s HEAT Study, the same patient population being treated in
the Company’s ongoing Phase III OPTIMA Study. These findings
are consistent with Celsion’s own analysis of the HEAT Study data,
which demonstrated that over a 3.5 year period, there was a
statistically significant two (2) year survival benefit for
patients treated with ThermoDox® plus optimized RFA over the
optimized RFA only group.
"There is clear evidence that the duration of
the RFA regimen used in combination with ThermoDox® is critical, as
was demonstrated in the NIH’s independent analysis," said Riccardo
Lencioni, MD, FSIR, EBIR, Professor of Interventional Radiology,
Vice Chair, Clinical and Translational Research, Department of
Interventional Radiology, University of Miami School of Medicine.
"Findings from this analysis provide additional confirmation that
increased RFA burn time improves OS in patients administered
ThermoDox®. For patients with intermediate HCC who are not optimal
candidates for surgery, there exists a dire unmet need, and being
able to offer these patients optimized RFA + ThermoDox® has the
potential to be a meaningful paradigm shift in the current
management of this deadly disease.”
“It is an honor to have confirmatory support
from the NIH that the use of RFA for more than 45 minutes in
patients treated with ThermoDox® can have a correlative impact on
reductions in tumor size and OS in patients with primary liver
cancer,” said Michael H. Tardugno, Celsion's chairman, president
and chief executive officer. “This analysis provides further
validation for our ongoing global Phase III OPTIMA Study. In
addition, learnings from a computational modeling study, an
experimental animal study and the HEAT Study post hoc subgroup
analysis, all of which are consistent with each other and which --
when examined together -- suggest a clearer understanding of a key
ThermoDox heat-based mechanism of action: the longer the target
tissue is heated, the greater the doxorubicin tissue
concentration.”
Presentation Details
Abstract Number:
16013790
Title: RFA Plus Lyso
Thermosensitive Liposomal Doxorubicin Improves Survival Using
Metric of RFA Duration per Tumor Volume: Retrospective Analysis of
Prospective Randomized Controlled Trial
Session: Interventional
Oncology Series: Hepatocellular Carcinoma and Cholangiocarcinoma
(VSI021)
Date and Time: Monday,
November 28, 2016, 1:00 pm to 6:00 pm CT
The NIH presentation will be available on
Celsion’s website under “News & Investors – Scientific
Presentations.”
About the OPTIMA Study
The Phase III OPTIMA Study is expected to enroll
up to 550 patients in up to 75 clinical sites in the United States,
Europe, China and Asia Pacific, and will evaluate ThermoDox® in
combination with optimized RFA, which will be standardized to a
minimum of 45 minutes across all investigators and clinical sites
for treating lesions three to seven centimeters, versus
standardized RFA alone. The primary endpoint for the trial is
Overall Survival, which is supported by post-hoc analysis of data
from the Company's 701 patient HEAT Study, where optimized RFA has
demonstrated the potential to significantly improve survival when
combined with ThermoDox®. The statistical plan calls for two
interim efficacy analyses by an independent Data Monitoring
Committee (iDMC).
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®, HEAT Study/HCC,
OPTIMA Study/HCC)
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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