Celsion`s Global Phase III ThermoDox Trial Expands to Malaysia and the Philippines

* Reuters is not responsible for the content in this press release.

Mon Oct 19, 2009 10:25am EDT

ThermoDox`s global footprint covers all major HCC markets
COLUMBIA, Md.--(Business Wire)--
Celsion Corporation (NASDAQ: CLSN) announced today that it has received approval
from the regulatory agencies in the Philippines and Malaysia for its Pivotal
Phase III primary liver cancer Clinical Trial Application. 

Celsion`s global Phase III trial is evaluating the efficacy and safety of
ThermoDox in combination with radiofrequency ablation (RFA) when compared to RFA
alone. The trial will enroll up to six hundred patients and is currently being
conducted in China, Japan, Hong Kong, Korea, Taiwan, Italy, the United States
and Canada. Expansion of the trial to the Philippines and Malaysia provides
assurance that the trial will be enrolled in an efficient and timely manner.
With recently announced CTA approval by the Chinese sFDA and imminent agreement
by the Thai FDA, Celsion expects to have sixty sites activated by the end of the
year. Completion of patient enrollment is expected to occur in the first half of
2010. 

"Acceptance of our CTA by the Philippine and Malaysian regulatory authorities
provides Celsion with trial agreements in key countries where primary liver
cancer is most prevalent. We have again posted a significant milestone and are
executing against our strategy to conduct our Phase III HCC study in a manner
that will provide basis for NDA submissions in regions where liver cancer is
endemic," stated Michael H. Tardugno, Celsion`s President and Chief Executive
Officer. "We now successfully secured regulatory authorization in 10 of 11
targeted countries covering approximately 80% of the world`s HCC population.
With the incidence of HCC growing at a reported 5% annually, the World Health
Organization projects it to be the world`s #1 cancer by 2020." 

Mr. Tardugno concluded, "With RFA emerging as the global first line treatment
for early stage HCC; ThermoDox`s potential to improve the efficacy of this cost
effective procedure provides Celsion with a significant ready made market. Our
goal is to provide the promise of our tumor targeting anti-cancer technology to
HCC patients with few options as rapidly as possible." 

About Primary Liver Cancer

Mortality among primary liver cancer patients is one of the world`s highest and
ranks as the fifth most common solid tumor cancer. The incidence of primary
liver cancer in the USA is approximately 20,000 cases per year and is rapidly
growing worldwide. Globally there are approximately 660,000 cases per year, with
the major risk factor being Hepatitis B and C in high prevalence in developing
countries. The standard first line treatment for liver cancer is surgical
resection of the tumor, but 70% to 80% of patients are ineligible for surgery.
Radio frequency ablation (RFA) has increasingly become the standard of care for
non-resectable liver 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. . Celsion is evaluating it`s lead
drug, ThermoDox, in combination with RFA to improve the rang and efficacy of the
procedure. 

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. 

ThermoDox has also demonstrated evidence of efficacy in a Phase I study for
primary liver cancer. Celsion has been granted FDA Orphan Drug designation for
ThermoDox and is conducting a pivotal global Phase III study in primary liver
cancer under a FDA Special Protocol Assessment. For recurrent chest wall breast
cancer, ThermoDox(R) 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
in the U.S. within calendar year 2010 

ThermoDox is a registered trademark of Celsion Corporation

About Celsion

Celsion is dedicated to the development and commercialization of innovative
oncology drugs including tumor-targeting treatments using focused heat energy in
combination with heat-activated drug delivery systems. Celsion has licensed
ThermoDox to Yakult-Honsha for the Japanese market and has a partnership
agreement with Phillips Medical to jointly develop its heat activated liposomal
technology in combination with high intensity focused ultrasound to treat
difficult cancers. 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.

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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