Celsion Corporation Announces Independent NIH Analysis Showing Treatment with ThermoDox® Plus RFA May Significantly Improve...
September 12 2016 - 8:00AM
Conclusions Drawn from Results of Celsion’s HEAT
Study Prompted NIH Analysis; Prior Subgroup Analysis of HEAT
Study by Celsion Demonstrated a Two-Year Overall Survival Benefit
Compared to Treatment with RFA Alone
Celsion Corporation (NASDAQ:CLSN) today announced that the
National Institutes of Health (NIH) has conducted an independent
retrospective analysis of data from the intent-to-treat population
of the Company’s HEAT Study, a 701-patient study investigating
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 will
be presented during an oral session on Monday, November 28, 2016 at
1:50 pm CT during the 102nd Scientific Assembly and Annual Meeting
of the Radiological Society of North America (RSNA) to be held on
November 26 – December 2, 2016 in Chicago, IL. Celsion is currently
studying the use of RFA as a heat source both for tumor ablation
and to activate ThermoDox® as a means of treating the area
surrounding the tumor, where untreated tumor may be present.
The NIH analysis, which sought to evaluate the
correlation between RFA burn time per tumor volume (min/ml) and
clinical outcome in patients treated with ThermoDox, concluded that
increased burn time per tumor volume substantially improved
survival in patients with solitary lesions treated with RFA +
ThermoDox® compared to patients treated with RFA alone. These
findings are consistent with Celsion’s analysis of the HEAT Study
data showing that in patients treated with RFA for more than 45
minutes, standardized RFA plus ThermoDox resulted in a
statistically significant improvement in overall survival (OS)
compared to standardized RFA alone.
“The NIH’s independent analysis provides new
confirmatory support indicating 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 overall survival
in patients with primary liver cancer,” said Michael H. Tardugno,
Celsion's chairman, president and chief executive officer. “We are
encouraged that the NIH findings are consistent with Celsion’s
analysis of the HEAT Study data showing that in patients treated
with RFA for more than 45 minutes, standardized RFA plus ThermoDox
demonstrated a statistically significant improvement in overall
survival compared to standardized RFA alone.”
Mr. Tardugno added, “We also think it is
noteworthy that Celsion’s latest 285 patient subgroup OS readout
from the HEAT Study reported that over a 3.5 year period, there was
a consistent two-year survival benefit for patients with primary
liver cancer – one of the most prevalent and most deadly types of
cancer in the world – who were treated with ThermoDox plus
optimized RFA over the optimized RFA-only group.”
“We are pleased that the NIH findings will be
presented to the scientific community at the 2016 RSNA Annual
Meeting. We firmly believe that this event will advance the
understanding of new and potentially curative approaches to the
treatment of primary liver cancer, and that it will also provide
strengthened validation for our ongoing global Phase III OPTIMA
study, which is evaluating ThermoDox in combination with optimized
RFA standardized to a minimum of 45 minutes versus standardized RFA
alone in the treatment of primary liver cancer,” Mr. Tardugno
said.
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
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
Celsion (NASDAQ:CLSN)
Historical Stock Chart
From Mar 2024 to Apr 2024
Celsion (NASDAQ:CLSN)
Historical Stock Chart
From Apr 2023 to Apr 2024