Columbia, MD August 27, 2007: CELSION CORPORATION (AMEX: CLN) today announced that it has reached agreement with investigators at Duke University to supplement the Phase I dose escalation study for recurrent breast cancer at the chest wall, currently being performed under an investigator IND at Duke University, through the filing of a Company IND using the same clinical protocol. Celsion plans to add up to three additional sites in the study.
"The clinical activity observed in the first evaluable patients enrolled in the study suggest that the combination of ThermoDox® and localized hyperthermia may have potential for clinically important anti-tumor activity on the chest wall," said Kimberly Blackwell, MD, Associate Professor, Division of Medical Oncology, Duke University Medical Center. "The addition of new sites to the study should accelerate enrollment allowing us to more quickly evaluate whether the preliminary results seen in a handful of patients are seen in a slightly larger patient population. It will also allow us to more quickly learn more about any potential treatment related side effects."
The Company also announced that New York University Medical Center is expected to be the first additional site to join the roster of clinical sites in the study under the leadership of Dr. Franco Muggia, M.D., its Professor of Oncology, Director of the Kaplan Comprehensive Cancer Center, the Breast Cancer Research Program, and the Division of Medical Oncology. Dr. Muggia said "The data are very preliminary but we are so encouraged by the early response for this drug that we are willing to commit the time and resources to help explore treatment of this difficult to treat disease."
Mr. Michael H. Tardugno, Celsion's President and Chief Executive Officer added, "The results reported in this study to date are remarkable at this early stage. We believe that this treatment could offer relief to patients with this debilitating disease. In addition to Dr. Blackwell, several key opinion leaders are intrigued by the results to date and have expressed interest in participating by adding additional sites to the study. The addition of new sites will enable us to accelerate the completion of the study. Moreover, these early data confirm our belief that the localized delivery of high concentrations of chemotherapy in short time intervals through a combination of ThermoDox and mild hyperthermia has the potential to be effective in treating solid tumors."
ThermoDox is Celsion's proprietary heat-sensitive liposomal encapsulation of doxorubicin, an approved and frequently used anti-cancer drug used in the treatment of various cancers including breast cancer. Localized mild hyperthermia (40-42oC) releases the entrapped doxorubicin from the liposome. This delivery technology enables high concentrations of doxorubicin to be deposited preferentially in a targeted tumor. Duke University is currently enrolling patients in the above Phase I study at Duke University Medical Center. Patients who may be interested in enrolling in the study should contact the Duke Protocol office at (919) 660-1278 or visit the Duke hyperthermia website at http://hyperthermia.mc.duke.edu/clinical_trials.htm.
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, University of Hong Kong, Cleveland Clinic, North Shore Long Island Jewish Health System.
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.
For Further Information Contact:
Paul G. Henning