LAWRENCEVILLE, N.J.,
July 28, 2014 /PRNewswire/
-- Celsion Corporation (NASDAQ: CLSN) today announced updated
results from its retrospective analysis of the Company's
701-patient HEAT 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).
As of June 30, 2014, the latest
quarterly Overall Survival (OS) analysis demonstrated that in a
large, well bounded, subgroup of patients (n=285, 41% of the study
patients), the combination of ThermoDox® and optimized RFA provided
a 57% improvement in OS compared to optimized RFA alone. The
Hazard Ratio at this analysis is 0.639 (95% CI 0.419 – 0.974) with
a p-value of 0.037.
"As the data from the HEAT Study matures, it increasingly
underscores the significant potential of ThermoDox® plus optimized
RFA to markedly improve Overall Survival in primary liver cancer
patients," stated Riccardo Lencioni,
MD, FSIR, EBIR, Professor and Director of the Diagnostic Imaging
and Intervention at the Pisa University School of Medicine in
Italy. "There is a pressing need for new treatment options to
address HCC, which is a highly prevalent and deadly cancer. The
consistency and strength of the HEAT Study data over each of the
last five quarterly data analyses provide a strong rationale and
clear roadmap for further development of ThermoDox® in this
indication."
As of June 30, 2014, data from the
latest HEAT Study post-hoc analysis continued to strongly suggest
that ThermoDox® may significantly improve OS compared to a RFA
control in patients whose lesions undergo RFA treatment for 45
minutes or more. These findings apply to patients with single
HCC lesions (64.4% of the HEAT Study population) from both size
cohorts of the HEAT Study (3-5 cm and 5-7 cm) and represent a
subgroup of 285 patients. For this group, clinical results
indicate a 57% improvement in OS, a Hazard Ratio of 0.639 (95% CI
0.419 – 0.974), and a p-value of 0.037.
"The post-hoc HEAT Study data is striking in that it has
consistently shown a marked OS benefit for ThermoDox® plus
optimized RFA versus RFA alone in each of the quarterly data
sweeps, with this 5th, and final data set demonstrating
that this survival benefit is statistically significant," stated
Michael Tardugno, Celsion's
President and Chief Executive Officer. "This impressive clinical
data set, together with prospective supportive preclinical study
results and multivariate Cox Regression Analyses, reinforces our
confidence in the protocol for our Phase III OPTIMA Study in
primary liver cancer, which is evaluating ThermoDox® in combination
with a standardized RFA protocol in primary liver cancer."
The HEAT Study and prior post-hoc analyses were presented at
multiple medical conferences over the past year, including: the
2014 American Society of Clinical Oncology 50th Annual Meeting in
June 2014; the 5th European
Conference on Interventional Oncology in April 2014; the International Liver Cancer
Association Annual Conference in September
2013; the European Conference on Interventional Oncology in
June 2013; and the World Conference
on Interventional Oncology in May 2013. Presentations were
made by some of the most highly recognized liver cancer researchers
and key HEAT Study investigators. Quarterly overall survival
data analyses have been conducted with the full support of these
researchers and clinical investigators.
The Company notes that, while the data and supporting analysis
from the HEAT Study warrant additional clinical development, the
information should be viewed with caution since it is based upon a
retrospective analysis and this subgroup of the HEAT Study has not
reached its median point for OS analysis.
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.
The pipeline also includes EGEN-001, a DNA-based immunotherapy for
the localized treatment of ovarian and brain cancers. Celsion
has three platform technologies for the development of novel
nucleic acid-based immunotherapies and other anti-cancer DNA or RNA
therapies, including TheraPlas™ and TheraSilence™. For more
information on Celsion, visit our website:
http://www.celsion.com.
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 or the possible failure to make such acquisitions or
licenses; 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
SOURCE Celsion Corporation