Celsion Announces Acceleration Plans for Its Breast Cancer Phase I Study.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 ) 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([R]) and localized hyperthermia hyperthermia /hy·per·ther·mia/ (-ther´me-ah) hyperpyrexia; greatly increased body temperature.hyperther´malhyperther´mic malignant 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 Side effects Effects of a proposed project on other parts of the firm. ." The Company also announced that New York University New York University, mainly in New York City; coeducational; chartered 1831, opened 1832 as the Univ. of the City of New York, renamed 1896. It comprises 13 schools and colleges, maintaining 4 main centers (including the Medical Center) in the city, as well as the 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 de·bil·i·tat·ing adj. Causing a loss of strength or energy. Debilitating Weakening, or reducing the strength of. Mentioned in: Stress Reduction 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 doxorubicin /doxo·ru·bi·cin/ (dok?so-roo´bi-sin) an antineoplastic antibiotic, produced by Streptomyces peucetius, which binds to DNA and inhibits nucleic acid synthesis; used as the hydrochloride salt and as a liposome-encased , 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 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. . 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 The University of Hong Kong (commonly abbreviated as HKU, pronounced as "Hong Kong U") is the oldest tertiary institution in Hong Kong. Its motto is "Sapientia et Virtus" in Latin, and " , Cleveland Clinic, North Shore Long Island Jewish Health System. 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 Safe Harbor 1. A legal provision to reduce or eliminate liability as long as good faith is demonstrated. 2. A form of shark repellent implemented by a target company acquiring a business that is so poorly regulated that the target itself is less attractive. " 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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