Columbia, MD – March 23, 2007: CELSION CORPORATION (AMEX: CLN) today announced it has filed for a Special Protocol Assessment (SPA) with the U.S. Food and Drug Administration (FDA) for the design of its phase III trial of ThermoDox™ (Thermally Sensitive Liposomal Doxorubicin) in combination with radiofrequency ablation (RFA) to treat patients with non-resectable Hepatocellular Carcinoma (HCC). The Phase III trial, a randomized, double-blinded study, will examine the efficacy and safety of ThermoDox plus RFA versus RFA-alone. As proposed, the global trial is expected to enroll and randomize approximately 600 patients.
Dr. William Hahne, Celsion's Vice President of Research and Development, commented, "This filing is the culmination of over a year's dialogue with the FDA regarding endpoints and clinical study design for HCC, Celsion's lead indication. We believe we have addressed all of the Agency's suggestions on trial design and endpoints, and expect to receive a response back in late spring or early summer."
Michael Tardugno, Celsion's President and Chief Executive Officer, added, "Submission of our protocol is an important milestone for Celsion as it clearly demonstrates our commitment to ThermoDox as a treatment for primary liver cancer. Clearance through the SPA process will provide a clear pathway to approval. By commercializing ThermoDox, Celsion will address the unmet medical needs of HCC patients, who have very few treatment options. Our objective is to improve the efficacy of RFA, the standard of care therapy, and to provide another treatment option for this indication. We expect this SPA process enables the fastest path to market. We will disclose more details on our Phase III program as we near enrollment."
About Special Protocol Assessment: A Special Protocol Assessment (SPA) from the FDA is an agreement that the Phase III trial protocol design, clinical endpoints, and statistical analyses are acceptable to support regulatory approval. An SPA is binding upon the FDA unless a substantial scientific issue essential to determining safety or efficacy is identified after the testing is begun. For more information please visit the FDA website: www.fda.gov/CbER/gdlns/protocol.pdf.
About Hepatocellular Carcinoma: Hepatocellular Carcinoma (HCC) is the most common form of primary liver cancer, and one of the most deadliest forms of cancer. It is estimated that up to 90% of liver cancer patients will die within five years of diagnosis. The incidence of primary liver cancer (approximately 19,000 new cases per year in the US) is relatively low compared to other cancers in the US, but is the #4 cancer worldwide estimated at over 500,000, with particularly high incidence in Asia. The most common underlying etiologies of HCC are Hepatitis B, C, and Cirrhosis, which are also on the rise in the West.
Although the most successful treatments for primary liver cancer are either surgical resection or liver transplantation, unfortunately over 80% of these HCC patients are non-resectable and only candidates for minimally invasive procedures such as radiofrequency ablation (RFA). Early stage liver cancer generally has few symptoms and delay detection and diagnosis, and when finally detected the tumor frequently is too large for surgery. There are few alternative treatments, since radiation therapy and chemotherapy have been largely ineffective.
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, Massachusetts Institute of Technology, Harbor UCLA Medical Center, Montefiore Medical Center and Memorial Sloan-Kettering Cancer Center in New York City, Roswell Park Cancer Institute in Buffalo, New York, and Duke University..
Celsion has also developed a microwave based system, the Prolieve Thermodilatation® system, for the treatment of benign prostatic hyperplasia which is marketed in the United States under an exclusive distribution agreement with Boston Scientific Corporation. 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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