Celsion Obtains Supportive FDA Guidance to Company`s CMC Submission

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Mon Aug 17, 2009 7:00am EDT

Celsion to Commence Validation and Scale Up of Commercial ThermoDox
Manufacturing Process
COLUMBIA, Md.--(Business Wire)--
Celsion Corporation (NASDAQ:CLSN), a leading oncology drug development company,
today announced that the FDA has provided the Company with positive guidance at
a Type C Chemistry Manufacturing and Controls ("CMC") meeting recently held at
the FDA`s Office of New Drug Quality Assessment. 

The FDA has provided the Company with the oral and written guidance that permits
Celsion to implement and validate process improvements to the manufacturing
methods used to produce ThermoDox, the Company`s lead product in a global Phase
III clinical study for primary liver cancer. Based on FDA`s guidance, the
Company intends to move forward with its plans to scale up the ThermoDox
manufacturing process so that larger, more economical batches can be
manufactured at quality levels that support commercial launch plans. 

"FDA`s guidance and continued willingness to collaborate with Celsion is very
much appreciated, " stated Michael H. Tardugno, Celsion's President and Chief
Executive Officer. "Our close consultation with the FDA`s CMC group from the
start of ThermoDox`s development has allowed us to successfully mitigate the
risks common to CMC programs. We now have well defined clinical, regulatory and
manufacturing pathways to commercialization and are pleased to be taking the
proper steps to ensure manufacturing capacity is in place to support product
launch." 

Celsion`s global Phase III Primary Liver cancer study of ThermoDox in
combination with radiofrequency ablation is being conducted in agreement with
FDA under Special Protocol Assessment guidance. The Company expects patient
enrollment to be complete in the spring of 2010. Celsion is conducting a second
registrational trial to evaluate ThermoDox in combination with hyperthermia to
treat recurrent chest wall cancer. ThermoDox incorporates a unique heat
sensitive liposomal formulation of doxorubicin and has shown remarkable evidence
of clinical activity in early stage clinical trials. The market potential for
ThermoDox is well in excess of $1 billion. 

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 (39.5-42 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 under an agreement with FDA for 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. 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. Additional information on these ThermoDox clinical
studies may be found at http://www.clinicaltrials.gov

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 

Copyright Business Wire 2009

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