Celsion Reports on ThermoDox(TM) at American Society of Clinical Oncology Gastrointestinal Symposium.Researchers Report That 22 Patients Have Been Treated in a Phase I Study Using ThermoDox in Combination with Radiofrequency Ablation to Treat Patients with Unresectable Hepatic Malignancies with No Unexpected Toxicity COLUMBIA, Md. -- CELSION CORPORATION (AMEX AMEX See: American Stock Exchange :CLN) today reported that Dr. Bradford J. Wood, Chief, Interventional Radiology Research at the National Institutes of Health's National Cancer Institute presented the progress of a Phase I dose escalation study, using ThermoDox, to treat unresectable liver cancer. ThermoDox, a heat activated liposomal formulation of doxorubicin, in conjunction with Radiofrequency Ablation (RFA) was used with limited and manageable toxicity to treat 22 patients, 8 with primary hepatocellular carcinoma and 14 with metastatic liver cancer, at doses of up to 60 mg/mU. The study is being performed at the National Cancer Institute (NCI) as part of a Cooperative Research and Development Agreement “CRADA” redirects here. For other uses, see CRADA (disambiguation). A Cooperative Research and Development Agreement (CRADA) is an agreement between a government agency and a private company to work together. (CRADA), under the leadership of Dr. Wood and Dr. Steven K. Libutti, Senior Investigator, Head, Tumor Angiogenesis Section, Surgery Branch, CCR, NCI; and at Queen Mary Hospital There are several Queen Mary Hospitals in the world:
In the study, patients with up to 4 lesions ranging from 3 to 7 centimeters are eligible to receive ThermoDox at doses ranging from 20 to 70 mg/mU. The effect of the treatment on the diameter of the lesions is followed using MRI, PET and contrast enhanced CT scans taken pre-treatment and at one and three months post-treatment. Lesion diameters will be compared to those of other patients treated with RFA alone. This study, being carried out by Celsion and the NCI continues to enroll patients into the 60 mg/mU treatment cohort. Celsion has licensed the global rights to the temperature-sensitive liposome technology from Duke University where ThermoDox is also being used in this Phase I clinical study of patients with recurrent chest wall breast cancer under the care of Dr. Kim Blackwell, the principal investigator. Dr. William Hahne, Celsion's Vice President of Research and Development, commented "We are pleased that dose in this study continues to escalate safely as clinical evidence suggests that a higher dose should result in increased efficacy. We are continuing to work with the FDA to finalize endpoints for a Phase III study in primary liver cancer, to be conducted by Celsion, in which we expect to initiate enrollment in 2007. This work will be used to refine tumor targeting and ultimately to improve the efficacy of drugs using our heat activated delivery system." 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. |
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