Columbia, MD - November 8, 2005: CELSION CORPORATION (AMEX: CLN) today announced that it had agreed to provide Duke University with a research grant and clinical supplies of ThermoDox, Celsion's proprietary doxorubicin-encapsulated thermo-sensitive liposome, to support a Phase I, open-label study of the safety and pharmacokinetics in patients with local-regionally advanced breast cancer. The heat required to trigger doxorubicin release from the temperature sensitive liposome will be provided by a BSD 500 system.
Duke University has previously reported promising results from a Phase I breast cancer study designed to demonstrate the ability of thermotherapy to enhance the therapeutic activity of non temperature sensitive liposomal encapsulations of doxorubicin plus traditional paclitaxel (Taxol(R)) in the management of locally advanced breast cancer. The lead investigator on both the reported Phase I study and a recently completed related Phase II study was Kimberly Blackwell, M.D. of Duke University Medical Center.
Dr. Blackwell said, "Given the potential of ThermoDox to provide higher concentrations of doxorubicin in the immediate area of the tumor, I am interested in studying the ability of ThermoDox to further enhance the therapeutic action previously achieved by the use of heat in combination with liposomal doxorubicin. ThermoDox will offer an exciting potential treatment option to this patient group for whom the medical options are very limited."
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.
Dr. Lawrence Olanoff, Celsion's Chief Executive Officer, commented, "We are very pleased to be able to support this study as a way of continuing Celsion's past efforts to develop better treatments for breast cancer. Strategically this indication fits Celsion very well, in that the heating device required to trigger the release of doxorubicin from the ThermoDox formulation already exists. Together with our current Phase I study in liver cancer, this breast cancer study continues our transition from a medical device company to a biopharmaceutical concern focused on development of oncology products."
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. 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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