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Celsion Provides Update on Status of Special Protocol Assessment (SPA) Submission.


COLUMBIA, Md. -- CELSION CORPORATION (AMEX AMEX

See: American Stock Exchange
: CLN CLN Clean
CLN Community Learning Network
CLN Colon
CLN Celsion Corporation
CLN Class Library for Numbers
CLN Credit Linked Note
CLN Comitato di Liberazione Nazionale (Committee of National Liberation)
CLN Corn Lethal Necrosis
) today announced that, in conjunction with its Phase III Primary Liver Cancer protocol submission under the SPA Guidance, the Food and Drug Administration (FDA FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
) has requested an update to the study's Radiology Charter. The company provided the updated document to the Agency on the date of the request, September 19, 2007.

With this submission, Celsion now anticipates the FDA's response to its application on or about September 28, 2007.

Mr. Michael H. Tardugno, Celsion's President and Chief Executive Officer, commented, "The FDA's request is consistent with the SPA process and does not in anyway suggest that approvability of our pivotal study is at issue. We have confidence in our submission and we are appreciative of the Agency's collaboration with Celsion in order to expedite their review of our application."

About Thermodox

ThermoDox is Celsion's proprietary heat-sensitive liposomal encapsulation of doxorubicin doxorubicin /doxo·ru·bi·cin/ (dok?so-roo´bi-sin) an antineoplastic antibiotic, produced by Streptomyces peucetius, which binds to DNA and inhibits nucleic acid synthesis; used as the hydrochloride salt and as a liposome-encased , an approved and frequently used anti-cancer drug used in the treatment of various cancers including breast cancer. Localized mild hyperthermia hyperthermia /hy·per·ther·mia/ (-ther´me-ah) hyperpyrexia; greatly increased body temperature.hyperther´malhyperther´mic

malignant hyperthermia
 (40-42 degrees C) releases the entrapped doxorubicin from the liposome liposome (lī`pəsōm', lĭp`ə–), microscopic, fluid-filled pouch whose walls are made of layers of phospholipids identical to the phospholipids that make up cell membranes. . This delivery technology enables high concentrations of doxorubicin to be deposited preferentially in a targeted tumor.

About Celsion:

Celsion is dedicated to the development and commercialization of oncology 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 The University of Hong Kong (commonly abbreviated as HKU, pronounced as "Hong Kong U") is the oldest tertiary institution in Hong Kong. Its motto is "Sapientia et Virtus" in Latin, and " , Cleveland Clinic, North Shore Long Island Jewish Health System. Additional information about Celsion Corporation can be found on the Celsion web site at 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 The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and  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.
COPYRIGHT 2007 Business Wire
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Copyright 2007, Gale Group. All rights reserved.

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Publication:Business Wire
Date:Sep 20, 2007
Words:365
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