Celsion Announces Phase III HEAT Study of ThermoDox(R) in

Celsion Announces Phase III HEAT Study of ThermoDox(R) in Primary
Liver Cancer Reaches Target Number of Events for Unblinding 
Company Begins Data Collection, Expects to Report Top Line Data in
January 2013; Reiterates Strong Balance Sheet Position 
LAWRENCEVILLE, NJ -- (Marketwire) -- 11/09/12 --  Celsion Corporation
(NASDAQ: CLSN), a leading oncology drug development company, today
announced that it projects that a minimum of 380 events of
progression have been realized in the Company's pivotal, Phase III
HEAT Study, a multinational, double-blind, placebo-controlled,
pivotal study of ThermoDox(R) in combination with radiofrequency
ablation (RFA) for the treatment of hepatocellular carcinoma (HCC),
also known as primary liver cancer. According to protocol, 380 events
of progression, subject to confirmation by the Study's independent
Data Monitoring Committee (DMC), trigger the data collection process,
unblinding and final analysis of the results by the DMC. Progression
Free Survival (PFS) is the HEAT Study's primary endpoint. The HEAT
Study has been granted Special Protocol Assessment by the FDA.
Following DMC review, the Company plans to disclose top line results,
an announcement that is expected to occur in January 2013. 
"The HEAT Study addresses a significant and growing global unmet
medical need in oncology, primary liver cancer. With a positive
outcome, ThermoDox(R) will become the most important 1st line therapy
for patients with non-resectable disease," said Michael H. Tardugno,
Celsion's President and Chief Executive Officer. "The positive
implications of this study, for patients and their families, the
healthcare community, our investors and employees, cannot be
overestimated."  
Mr. Tardugno added: "We enter this transformative period from a
position of financial strength, having taken ThermoDox(R) through to
pivotal data while maintaining full worldwide rights outside of
Japan, a minimal number of shares outstanding and a strong balance
sheet." The Company ended the second quarter of 2012 with $24 million
in cash, subsequently supplemented by $4.7 million in option and
warrant exercises. Celsion also has available to draw an additional
$5 million from a $10 million loan facility with Oxford Finance LLC
and Horizon Technology Finance Corporation, pending positive data
from the Phase III HEAT Study. "Consistent with our previous
guidance, we have no plans to raise additional capital before
disclosing top line data from the HEAT Study which, if positive, will
vastly expand the Company's strategic and financing options." 
The HEAT Study, which has enrolled a total of 701 patients, has been
designated as a Priority Trial for liver cancer by the National
Institutes of Health, has received Fast Track Designation from the
FDA and has received Orphan Drug Designation in both the U.S. and
Europe. ThermoDox(R) is also being evaluated in two Phase II trials
for patients with recurrent chest wall breast cancer and colorectal
liver metastases. 
About ThermoDox(R) and the Phase III HEAT Study 
ThermoDox(R) is a proprietary heat-activated liposomal encapsulation
of doxorubicin, an approved and frequently used oncology drug for the
treatment of a wide range of cancers. In the HEAT Study, ThermoDox(R)
is administered intravenously in combination with Radio Frequency
Ablation (RFA). Localized mild hyperthermia (39.5 - 42 degrees
Celsius) created by the RFA releases the entrapped doxorubicin from
the liposome. This delivery technology enables high concentrations of
doxorubicin to be deposited preferentially in a targeted tumor. 
For primary liver cancer, ThermoDox(R) is being evaluated in a
global, multi-center, randomized, pivotal Phase III HEAT Study at 79
clinical sites under an FDA Special Protocol Assessment. The study is
designed to evaluate the efficacy of ThermoDox(R) in combination with
RFA when compared to patients who receive RFA alone as the control.
The primary endpoint for the study is progression-free survival with
a secondary confirmatory endpoint of overall survival. Additional
information on the Company's ThermoDox(R) clinical studies may be
found at www.clinicaltrials.gov. 
About Celsion Corporation  
Celsion is a leading oncology company 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 by others; possible acquisitions of other technologies, assets
or businesses; possible actions by customers, suppliers, competitors,
regulatory authorities; and other risks detailed from time to time in
the Company's periodic reports filed with the Securities and Exchange
Commission.  
Investor Contact
David Pitts
Argot Partners
212-600-1902
David@argotpartners.com 
 
 
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