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Celsion Corporation Announces Updated Overall Survival Results from Phase III HEAT Study of ThermoDox® in Primary Liver Cancer



Celsion Corporation Announces Updated Overall Survival Results from Phase III
               HEAT Study of ThermoDox® in Primary Liver Cancer

Latest Data from Large Subgroup of Patients Shows that the Combination of
ThermoDox® and Optimized RFA Provides a Statistically Significant Survival
Improvement of Over 50%

Provides Basis for Further Development of ThermoDox® in HCC Patients

PR Newswire

LAWRENCEVILLE, N.J., Jan. 27, 2014

LAWRENCEVILLE, N.J., Jan. 27, 2014 /PRNewswire/ -- Celsion Corporation
(NASDAQ: CLSN) today announced that the latest overall survival data from its
post-hoc analysis of results from the Company's Phase III HEAT Study of
ThermoDox®, Celsion's proprietary heat-activated liposomal encapsulation of
doxorubicin in combination with radio frequency ablation (RFA), supports the
continued clinical development of ThermoDox® in a prospective pivotal Phase
III Study, subject to regulatory review and agreement. This analysis followed
the announcement on January 31, 2013, that the HEAT Study did not meet its
primary endpoint, progression-free survival (PFS).  As provided for in the
HEAT Study's Special Protocol Assessment (SPA) agreement with the U.S. Food
and Drug Administration (FDA), the Company continues to follow patients for
overall survival, the secondary endpoint of the Study.  Data from four
quarterly reviews of overall survival have been evaluated since the
announcement of top line PFS data.

Data from the updated HEAT Study analysis suggests that ThermoDox® may
significantly improve overall survival, compared to 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 (41% of the patients in the HEAT Study).  Updated OS
data from this subgroup of patients is summarized below:

  o In the patient subgroup treated in the ThermoDox® arm, whose RFA procedure
    lasted longer than 45 minutes (285 patients or 63% of single lesion
    patients) clinical results indicate a 55% improvement in overall survival,
    a Hazard Ratio of 0.64 (95% CI 0.41 – 1.00) and a P-value = 0.0495. Median
    overall survival for this subgroup has not yet been reached.
  o In contrast, the patient subgroup treated with ThermoDox® whose RFA
    procedure lasted less than 45 minutes in duration (167 patients or 37% of
    single lesion patients) indicated a Hazard Ratio of 1.12 (95% CI 0.68 –
    1.86) and a P-value = 0.66.  Median overall survival for this subgroup has
    not yet been reached.
  o The Hazard Ratios reported above warrants additional clinical development
    and should be viewed with caution since they are based on a retrospective
    analysis and the HEAT Study has not reached its median point for overall
    survival analysis.  Celsion will continue to follow patients in the HEAT
    Study to the secondary endpoint, overall survival, and will update the
    subgroup analysis based on RFA heating duration.

"The HEAT Study post-hoc data is compelling.  The combination of ThermoDox®
and an optimized RFA treatment appears to have a significant improvement in
overall survival in HCC patients," stated Dr. Nicholas Borys, Celsion's Chief
Medical Officer.  "While this conclusion is reached based on a post-hoc
evaluation, it is nonetheless supported by the consistency of the data seen
over a one year follow-up period, and by what is now a statistically
significant outcome for overall survival.  Our investigators are convinced
that RFA can and should be optimized in future trials."

The HEAT Study and prior post-hoc analyses were presented at three medical
conferences in 2013, including the World Conference on Interventional Oncology
in May; the European Conference on Interventional Oncology in June and the
International Liver Cancer Association Annual Conference in September. 
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.  

Additionally, Celsion has been consulting with its clinical advisors,
regulatory and expert statistician consultants and the FDA regarding the study
design and statistical plan for its proposed pivotal Phase III clinical
trial.  The Company anticipates initiating a multicenter global trial in the
first half of 2014.  

"These data continue to support our strong interest in ThermoDox® and its
potential as a first line treatment for a significant percentage of the
world's 750,000 newly diagnosed HCC patients," noted Michael H. Tardugno,
Celsion's President and Chief Executive Officer. "In addition to the FDA, the
Company is pursuing regulatory approval of its new Phase III clinical trial in
multiple countries, particularly those where HCC's prevalence represents an
important health issue.  In parallel with this effort, we are recruiting key
CRO partners to initiate the Study rapidly following regulatory agency
agreement. With our strong financial resources and the support of the global
HCC community, we are confident in our ability to conduct a timely and cash
efficient pivotal program."     

About Celsion Corporation

Celsion is dedicated to the development and commercialization of innovative
cancer drugs, including tumor-targeting treatments using focused heat energy
in combination with heat-activated liposomal drug technology.  Celsion has
research, license or commercialization agreements with leading institutions,
including the National Institutes of Health, Duke University Medical Center,
University of Hong Kong, the University of Pisa, the UCLA Department of
Medicine, the Kyungpook National University Hospital, the Beijing Cancer
Hospital and the University of Oxford.  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;
HEAT Study data is subject to further verification and review by the HEAT
Study Data Management Committee; 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.

Investor Contact
Jeffrey W. Church
Senior Vice President and
Chief Financial Officer
609-482-2455
jchurch@celsion.com

SOURCE Celsion Corporation

Website: http://www.celsion.com
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