Celsion Corporation Reports Good Progress in Its Cancer Drug Development Business.COLUMBIA, Md. -- Celsion Corporation (AMEX AMEX See: American Stock Exchange :CLN CLN Clean CLN Community Learning Network CLN Colon CLN Celsion Corporation CLN Class Library for Numbers CLN Credit Linked Note CLN Comitato di Liberazione Nazionale (Committee of National Liberation) CLN Corn Lethal Necrosis ): Celsion reports patients treated at new liver cancer site in Hong Kong: first patient treated in recurrent chest wall breast cancer Phase I study; production of first full scale GMP batch of ThermoDox and dissolution of device focused China joint venture. CELSION CORPORATION (AMEX:CLN) today announced several developments related to ThermoDox(TM) its proprietary heat activated 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. containing doxorubicin HCI. Queen Mary Hospital There are several Queen Mary Hospitals in the world:
The Company also announced that Dr. Kim Blackwell, Assistant Professor in the Department of Medicine and Radiation Oncology at Duke University Medical Center, had treated the first patient in a Phase I, dose-escalation, multi-dose study of the safety and pharmacokinetics of ThermoDox in combination with microwave heat to treat patients with local-regionally advanced recurrent breast cancer. Microwave heat is being provided by the use of a BSD (Berkeley Software Distribution) The software distribution facility of the Computer Systems Research Group (CSRG) of the University of California at Berkeley. 500 device. Local-regionally recurrent breast cancer is a condition that occurs in post mastectomy patients where lesions recur on the chest wall. There is currently no established standard of care for this condition. Celsion further announced that under its direction, a contract manufacturing facility has completed the production of the first full scale GMP GMP (guanosine monophosphate): see guanine. batch of ThermoDox using a process and formulation design suitable for commercial introduction. Most significantly, the new formulation consists of a single ready for use vial which is a substantial improvement over the triple vial system currently employed in its research trials, as it requires no complex pre-mixing process prior to use as an infusion. Dr. Lawrence Olanoff, Celsion's President and Chief Executive Officer commented, "We are very pleased to have had the opportunity to add Queen Mary Hospital to our Phase I liver cancer trial. Dr. Ronnie Poon is a world renowned expert in the treatment of liver cancer. The data generated at this site will augment the information being obtained at the National Cancer Institute. Overall, the results will better enable us to optimize the design of the Phase II/III pivotal study which we hope to commence around the end of this year. We are also very pleased to have initiated the Phase I study in patients with local regionally advanced recurrent breast cancer with Dr. Blackwell, who is a recognized leader in the development of treatments for this group of breast cancer patients. In addition, the development of the single vial easy-to-use formulation of ThermoDox is a milestone for this Company. Not only does it demonstrate our formulation development capabilities but it also facilitates enrollment of multiple sites for our later stage trials." In a separate development the Company announced that its joint venture, Celsion (China) Limited, formed in 2003, primarily to develop heating devices for use in the treatment of cancer, has been dissolved. Dr. Lawrence Olanoff, said, "When I joined Celsion in August 2005 the company was continuing to develop its own devices and drugs to be used together as combination therapies for the treatment of cancer. We have since changed our focus to develop only cancer drugs, some of which may be used in combination with existing heating devices. Although Celsion will continue to utilize study sites in Hong Kong and mainland China for pre-clinical and clinical development, we can manage these activities from the U.S. As a result, in the near term, we do not need to maintain a separate development/commercial operation in Hong Kong. As such, we have decided to dissolve the joint venture. We appreciate the assistance provided to date by our partners Asia Pacific Life Science Group." ABOUT CELSION: Celsion Corporation, based in Columbia, Maryland, is a biotechnology company dedicated to the development and commercialization of heat activated treatment systems for cancer. Celsion has research, license or commercialization agreements with leading institutions such as the National Institute 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. For more information on Celsion, visit our website: 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. In addition, Celsion's receipt of the royalty payments in connection with the sale of Celsion (Canada) depends upon the ability of Celsion (Canada) to develop the APA (All Points Addressable) Refers to an array (bitmapped screen, matrix, etc.) in which all bits or cells can be individually manipulated. APA - Application Portability Architecture technology and bring products to market. This involves, among other risks of a new enterprise, financing, regulatory and market acceptance risks. |
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