Celsion Files for Special Protocol Assessment for ThermoDox in combination with Radiofrequency Ablation for treatment of Non-Resectable Hepatocellular Carcinoma.COLUMBIA, Md. -- CELSION CORPORATION (AMEX AMEX See: American Stock Exchange :CLN) today announced it has filed for a Special Protocol Assessment (SPA) with the U.S. 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. ) for the design of its phase III trial of ThermoDox[TM] (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 ) to treat patients with non-resectable Hepatocellular Carcinoma (HCC). The Phase III trial, a 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 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 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. 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 Massachusetts Institute of Technology, at Cambridge; coeducational; chartered 1861, opened 1865 in Boston, moved 1916. It has long been recognized as an outstanding technological institute and its Sloan School of Management has notable programs in business, , Harbor UCLA Medical Center UCLA Medical Center is a hospital located on the campus of the University of California, Los Angeles in Los Angeles, California. It is rated as one of the top three hospitals in the United States and is the top hospital on the West Coast according to US News & World Report. , Montefiore Medical Center Montefiore Medical Center, in the Bronx, New York, is the university hospital of the Albert Einstein College of Medicine. The hospital, named after Moses Montefiore, is one of the 50 largest employers in New York State [1]. and Memorial Sloan-Kettering Cancer Center The Memorial Sloan-Kettering Cancer Center (MSKCC) in New York City is a cancer treatment and research institution founded in 1884 as the New York Cancer Hospital. The main campus is located at 1275 York Avenue, between 67th and 68th Streets, with other locations in New in New York City New York City: see New York, city. New York City City (pop., 2000: 8,008,278), southeastern New York, at the mouth of the Hudson River. The largest city in the U.S. , Roswell Park Cancer Institute The Roswell Park Cancer Institute is a cancer research and treatment center located in Buffalo, New York. Founded in 1898 by Dr. Roswell Park, it was the first dedicated medical facility for cancer treatment and research in the United States. in Buffalo, New York, and Duke University.. Celsion has also developed a microwave based system, the Prolieve Thermodilatation[R] system, for the treatment of benign prostatic hyperplasia benign prostatic hyperplasia n. Abbr. BPH A nonmalignant enlargement of the prostate gland commonly occurring in men after the age of 50, and sometimes leading to compression of the urethra and obstruction of the flow of urine. 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 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. |
|
||||||||||||||||
Printer friendly
Cite/link
Email
Feedback
Reader Opinion