Celsion Commences Global Phase III Study for Primary Liver Cancer.Study Protocol Receives IRB IRB See: Industrial Revenue Bond Approval in USA and Hong Kong, and the CTA An abbreviation for cum testamento annexo, Latin for "with the will annexed." Submission Has Been Accepted by China SFDA COLUMBIA, Md. -- CELSION CORPORATION (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on : CLN) announced today that two clinical sites are currently screening patients after receiving IRB approval for the Phase III study titled "A Phase III, Randomized ran·dom·ize tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es To make random in arrangement, especially in order to control the variables in an experiment. , Double-Blinded, Dummy-Controlled Study of the Efficacy and Safety of ThermoDox[R] (Thermally Sensitive Liposomal Doxorubicin) in Combination with Radiofrequency Ablation (RFA RFA right frontoanterior (position of the fetus). Radiofrequency ablation (RFA) A procedure in which radiofrequency waves are used to destroy blood vessels and tissues. Mentioned in: Prenatal Surgery ) Compared to RFA-Alone in the Treatment of Non-Resectable Hepatocellular Carcinoma (HCC)." In the USA, North Shore Hospital-Albert Einstein Medical School, led by Principal Investigator Dr. Thanjavur S. Ravikumar, MD, is currently screening patients and will be the lead clinical center in North America. In Hong Kong, Queen Mary Hospital There are several Queen Mary Hospitals in the world:
In addition, the submission of Celsion's clinical trial authorization (CTA) application for the Phase III protocol has been accepted by China SFDA, with authorization to enroll patients expected in August 2008. Clinical trial applications are currently being finalized for submission in Korea, Taiwan, Italy and Canada. Once approved in Italy, Dr. Riccardo Lencioni, M.D. from the University of Pisa The University of Pisa (Italian Università di Pisa) is one of the most renowned Italian universities. It is located in Pisa, Tuscany. It was formally founded on the September 3, 1343 by an edict of Pope Clement VI, although there had been lectures on law in Pisa since the will serve as the 3rd regional Principal Investigator to lead the European sites. This 40 center, 600-patient Phase III study is projected to enroll patients over approximately an 18 month period, and will conclude by Q4 2009. The Phase III study for HCC will evaluate the primary endpoint of Progression Free Survival, with secondary endpoints of Overall Survival, Patient-Reported Outcomes for quality of life, and Time to Local Recurrence, in addition to evaluating safety. The study has been posted on the Clinicaltrials.gov website at: http://clinicaltrials.gov/ct2/show/NCT00617981?term=thermodox&rank=2 Michael H. Tardugno, Celsion's President and Chief Executive Officer, commented "We are pleased to share our progress with all of our partners, especially our shareholders. Having launched a Phase III study within two months of securing a special protocol assessment (SPA) agreement with the United States 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. is a significant milestone for Celsion. Moreover, the acceptance of our CTA submission (considered an IND equivalent) by the Chinese regulatory authority demonstrates the value of our strategic focus and Celsion's ability to execute a complex global clinical strategy." "We are one step closer to providing the promise of ThermoDox to a cancer population that is in need of effective treatment options." concluded Mr. Tardugno. About ThermoDox[R]: ThermoDox[R] is Celsion's proprietary heat-sensitive liposomal encapsulation of doxorubicin, 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 Celsius) 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, and North Shore Hospital-Albert Einstein Medical School. 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 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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