Healthcare Industry News: Celsion
News Release - March 12, 2008
Celsion Commences Global Phase III Study for Primary Liver CancerStudy Protocol Receives IRB Approval in USA and Hong Kong, and the CTA Submission Has Been Accepted by China SFDA
COLUMBIA, Md.--(HSMN NewsFeed)--Celsion CORPORATION (NASDAQ: 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, Double-Blinded, Dummy-Controlled Study of the Efficacy and Safety of ThermoDox® (Thermally Sensitive Liposomal Doxorubicin) in Combination with Radiofrequency Ablation (RFA) 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, University of Hong Kong led by Principal Investigator Dr. Ronnie T. Poon, MD, is also currently pre-screening patients for the Phase III study and will be the lead clinical center in Asia.
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 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 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®: ThermoDox® 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 (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.
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 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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