Celsion Announces Results of Phase III HEAT Study of ThermoDox® in Primary Liver Cancer

  Celsion Announces Results of Phase III HEAT Study of ThermoDox® in Primary
                                 Liver Cancer

Company to Host Conference Call at 8:00 AM EST Today

PR Newswire

LAWRENCEVILLE, N.J., Jan. 31, 2013

LAWRENCEVILLE, N.J., Jan. 31, 2013 /PRNewswire/ -- Celsion Corporation
(NASDAQ: CLSN), a leading oncology drug development company, today announced
that ThermoDox® in combination with radiofrequency ablation (RFA) did not meet
the primary endpoint of the Phase III HEAT Study in patients with
hepatocellular carcinoma (HCC), also known as primary liver cancer.

Specifically, Celsion has determined, after conferring with its independent
Data Monitoring Committee (DMC) that the HEAT Study did not meet the goal of
demonstrating persuasive evidence of clinical effectiveness that could form
the basis for regulatory approval in the population chosen for study. The
HEAT Study was designed to show a 33% improvement in PFS with 80% power and a
p-value = 0.05. In the trial, ThermoDox® was well-tolerated with no
unexpected serious adverse events. The HEAT Study was conducted under a
Special Protocol Assessment agreed to with the U.S. Food and Drug
Administration (FDA).

"We are disappointed that the HEAT Study did not provide sufficient evidence
of clinical effectiveness of ThermoDox® as measured by the trial's primary
endpoint," said Michael H. Tardugno, Celsion's President and Chief Executive
Officer. "We will consider following the patients currently enrolled in the
HEAT Study to the secondary endpoint, Overall Survival (OS), and are
conducting additional analyses of the data from the trial in order to assess
the future strategic value of ThermoDox. We expect that the results will be
presented in the future at appropriate medical meetings. We wish to
acknowledge and thank the patients and investigators who participated in the

Celsion ended 2012 with a strong balance sheet that provides the Company the
opportunity to evaluate its future development plans. The Company projects
its unaudited cash and investment balance to be approximately $23 million as
of December 31, 2012 and approximately $27 million as of January 31, 2013.

Conference Call

The Company is hosting a conference call to discuss the Phase III HEAT Study
results at 8:00 a.m. EST today. To participate in the call, interested parties
may dial 1-888-466-4462 (Toll-Free/North America) or 1-719-457-2627
(International/Toll) and ask for the Celsion Corporation Phase III HEAT Study
Conference Call approximately 10 minutes before the call is scheduled to
begin. The call will also be broadcast live on the internet at

The call will be archived for replay at 2 p.m. EST on January 31, 2013, and
will remain available until February 14, 2013. The replay can be accessed at
1-877-870-5176 (Toll-Free/North America) or 1-858-384-5517
(International/Toll) using Conference ID: 4540212. An audio replay of the call
will also be available on the Company's website, http://www.celsion.com, for
30 days after 2p.m. EST on Thursday, January 31, 2013.

About the HEAT Study

HEAT (Hepatocellular Carcinoma Study of RFA and ThermoDox®) was an
international, multi-center, randomized, placebo-controlled study that
randomized 701 patients with intermediate (tumor size 3 cm to 7 cm),
unresectable HCC to 50mg/m^2 ThermoDox® plus RFA or RFA alone. The primary
endpoint of the study was progression-free survival, as defined by the Special
Protocol Assessment agreed to with the U.S. FDA. Safety and tolerability were
also evaluated.

The HEAT Study, the largest clinical trial to date in patients with
intermediate HCC, was conducted at 79 clinical sites around the world,
including the United States, Canada, Italy, China, Taiwan, Hong Kong, Korea,
Thailand, Malaysia and the Philippines.

About Hepatocellular Carcinoma

Hepatocellular carcinoma (HCC), also known as primary liver cancer, is
currently one of the most common and deadly forms of cancer worldwide. With
few approved treatment options, it is estimated that up to 90 percent of
unresectable (inoperable) liver cancer patients will die within five years of
diagnosis. HCC is the fourth leading cause of death from cancer and the third
most common in males. There are approximately 26,000 new cases per year in the
US and approximately 40,000 cases per year in Europe. However, HCC is rapidly
growing worldwide at approximately 750,000 cases per year, due to the high
prevalence of Hepatitis B and C in developing countries - more than 50 percent
of these new cases will be in China. HCC currently is the world's fifth
largest cancer and the World Health Organization estimates that HCC may become
the number one cancer worldwide by 2020, surpassing lung cancer.

About ThermoDox®

ThermoDox® is an investigational, proprietary heat-activated formulation of
liposomal doxorubicin, an approved and frequently used oncology drug for the
treatment of a wide range of cancers, and is currently being investigated in
clinical trials for its potential to treat patients with intermediate (tumor
size 3 to 7 cm), unresectable (inoperable) HCC. ThermoDox® is an
investigational treatment and is not approved by the FDA, EMA or other health

ThermoDox® enhances the efficacy of doxorubicin by encapsulating it with
Celsion's proprietary lysolipid thermally sensitive liposomes (LTSL). These
heat-sensitive liposomes change structure when heated to a specific
temperature (via a heat source like RFA), creating openings in the liposome
that release doxorubicin directly into the targeted tumor and surrounding
tissue. While the RFA targets the tumor, ThermoDox® delivers higher
concentrations of chemotherapy directly to the tumor site, capturing
micrometastases (tumors too miniscule to be detected) outside of the RFA
ablation zone, which are most commonly responsible for post-treatment disease
recurrence. In animal models, ThermoDox® has been shown to deliver 25 times
more doxorubicin into tumors than intravenous doxorubicin, and five times more
doxorubicin than standard liposomal formulations of the drug. Additionally,
ThermoDox® is less permeable across normal blood vessels than free
doxorubicin, minimizing systemic toxicity.

About Celsion Corporation

Celsion is a leading oncology company dedicated to the development and
commercialization of innovative cancer drugs. The company is focused on
advancing its heat-mediated, tumor-targeting drug delivery platform to address
difficult-to-treat cancers. 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:

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 need for Celsion to analyze the results
of the HEAT Study further; the need for Celsion to evaluateits future
development plans; cash projections are unaudited; 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
Jeffrey W. Church
Sr. Vice President – Corporate
Strategy and Investor Relations

Media Contact
Kimberly Ryan

SOURCE Celsion Corporation

Website: http://www.celsion.com
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