Celsion Announces Promising ThermoDox Clinical Results in Primary Liver Cancer Were Published in Expert Opinion

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Mon Mar 30, 2009 8:00am EDT

COLUMBIA, Md.--(Business Wire)--
Celsion Corporation (NASDAQ:CLSN), a leading oncology drug development company,
announced that promising Phase 1 ThermoDox clinical results in hepatocellular
carcinoma (HCC) or primary liver cancer have been published in the peer-reviewed
medical journal Expert Opinion on Pharmacology. The review article titled
"Lyso-thermosensitive liposomal doxorubicin: a novel approach to enhance
efficacy of thermal ablation of liver cancer" was published in the February
issue (Expert Opin. pharmacother. (2009)10(2):333-343). 

ThermoDox is a proprietary formulation of lyso-thermosensitive liposomal
doxorubicin (LTLD) used in combination with radiofrequency ablation (RFA) to
provide local tumor control. The primary author of the study, Professor Ronnie
TP Poon, M.D., University of Hong Kong, Queen Mary Hospital, Department of
Surgery, Hong Kong, China, concluded that among Child-Pugh class A-B patients
with medium or large tumors, ThermoDox is safe and demonstrates a statistically
significant dose-response effect. 

In the Phase 1 dose finding study, 24 patients (9 with HCC and 15 with liver
tumors metastatic from 9 other primary sites) were treated with a single 30-min
IV infusion of LTLD at 20, 30, 40, 50 or 60 mg/m2, starting 15 minutes before
RFA. Dr. Poon reports, "There was a statistically significant (p=0.0380) LTLD
dose response effect: median time to treatment failure for patients receiving at
least the maximum tolerated dose of 50 mg/m2 was 374 days while that for
patients receiving less than 50 mg/ m2 was 80 days. This is consistent with the
hypothesis that LTLD significantly increases RFA efficacy." 

"The study results featured in this publication support our strategy for
developing ThermoDox," commented Mr. Michael H. Tardugno, Celsion's President
and Chief Executive Officer. "Based on these encouraging Phase I results, we
initiated a pivotal Phase 3 registration trial under a special protocol
assessment with the FDA in 600 patients with unresectable HCC. We hope to
complete enrollment in this trial by the end of the first quarter of next year.
" 

About ThermoDox

ThermoDox in combination with hyperthermia has the potential to provide local
tumor control and improve quality of life. ThermoDox 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
including breast cancer. Localized mild hyperthermia (40-42 degrees Celsius)
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 is being evaluated in a 600 patient global
Phase III study at 40 clinical sites under an FDA Special Protocol Assessment.
The study is designed to evaluate the efficacy of ThermoDox 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 and enrollment is expected
to be completed in the first quarter of 2010. For recurrent chest wall breast
cancer, ThermoDox is being evaluated in a pivotal Phase I/II open-label,
dose-escalating trial that is designed to measure durable local complete
response at the tumor site. Celsion expects to enroll approximately 100 patients
across the United States and to complete the study by the first half of 2010.
Additional information on these ThermoDox clinical studies may be found at
http://www.clinicaltrials.gov

About Primary Liver Cancer

Primary liver cancer is one of the most deadly forms of cancer and ranks as the
fifth most common solid tumor cancer. The incidence of primary liver cancer is
approximately 20,000 cases per year in the United States and is rapidly growing
worldwide at approximately 1,000,000 cases per year, due to the high prevalence
of Hepatitis B and C in developing countries. The standard first line treatment
for liver cancer is surgical resection of the tumor, however 80% to 90% of
patients are ineligible for surgery. Radio frequency ablation (RFA) has
increasingly become the standard of care for non-resectable liver tumors, but
the treatment becomes less effective for larger tumors. There are few
non-surgical therapeutic treatment options available as radiation therapy and
chemotherapy are largely ineffective in the treatment of primary liver cancer. 

About Celsion

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 drug
delivery systems. Celsion has research, license, or commercialization agreements
with leading institutions such as the National Institutes of Health, Duke
University Medical Center, University of Hong Kong, Cleveland Clinic, and the
North Shore Long Island Jewish Health System. 

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.





Investors:
Celsion Corporation
Sean Moran, 410-290-5390
Senior Vice President and Chief Financial Officer
smoran@celsion.com
or
The Trout Group
Marcy Nanus, 646-378-2927
mnanus@troutgroup.com



Copyright Business Wire 2009

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