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 is providing an update to its SPA application for Primary Liver Cancer. As previously reported, the 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. requested and received an update to the study's Radiology Charter. Although the FDA could take an additional 45 days from the time of receipt to issue a formal response, at that time Celsion was advised that the submission would be acted upon within a week to ten days. Subsequently, the FDA has advised the company that the review is still in progress, but did not indicate a definitive date for the agency's issuance of the formal response. Mr. Michael H. Tardugno, Celsion's President and Chief Executive Officer, commented, "We continue to have confidence in our submission and we are appreciative of the Agency's collaboration with Celsion. We will provide an update as soon as we have a formal response. In the meantime Adv. 1. in the meantime - during the intervening time; "meanwhile I will not think about the problem"; "meantime he was attentive to his other interests"; "in the meantime the police were notified" meantime, meanwhile we are continuing our Phase III planning with the expectation that the SPA will be approved with a target of enrolling our first patient before the end of the year" About Thermodox ThermoDox is Celsion's proprietary heat-sensitive liposomal encapsulation of an approved and frequently used anti-cancer drug, doxorubicin which is 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 (39-42 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. |
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