Columbia, MD - MAY 16, 2007: CELSION CORPORATION (AMEX: CLN) today reported that on May 16, 2007 at the joint meeting of the World Congress on Interventional Oncology and the Society of Thermal Medicine, in Washington DC, Dr. Zeljko Vujaskovic, Associate Clinical Professor at Duke University, presented early data from a Phase I dose escalation and safety study using ThermoDox to treat patients with recurrent breast cancer on the chest wall. He reported that at low doses (three patients at 20mg/m2 and three patients at 30mg/m2), after only two cycles of a six cycle regimen, all six patients showed early signs of clinically meaningful activity, one patient had a complete response in the treated area, two patients had a partial response and three patients had stable disease following treatment.
Dr. Vujaskovic commented, "These results are unusual at this early stage in a study. A complete response at such a low dose indicates a biological "proof of principle" in these patients for whom there is no recognized standard of care. As such, this elegant technology for localized delivery of a high concentration of doxorubicin offers hope for a potential treatment option in the future."
Dr Kimberly Blackwell, Associate Professor of Medicine at Duke University, the primary investigator on the study continues to enroll patients in this study which is intended to provide the dosage to be used in a Phase II study which Celsion expects to initiate early next year. Dr Blackwell said, "The few patients reported on to date have tolerated the treatment well and there have been no unexpected reactions. The clinical activity demonstrated in this small number of patients suggests that the combination of ThermoDox and localized hyperthermia may have potentially clinically important anti-tumor activity on the chest wall. However, larger studies will be necessary in order to determine its ultimate safety and effectiveness."
Mr. Michael Tardugno, Celsion's President and Chief Executive Officer, commented, "This early demonstration of clinical activity and tumor response in a patient population with few viable treatment options is very encouraging. 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 will 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.
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