Clinical Activity for Celsion's ThermoDox(R) Reported in Newly Presented Data.Data Presented at the Joint Meeting of the World Congress on Interventional Oncology and the Society for Thermal Medicine Demonstrates Clinically Meaningful Activity of ThermoDox and Hyperthermia hyperthermia /hy·per·ther·mia/ (-ther´me-ah) hyperpyrexia; greatly increased body temperature.hyperther´malhyperther´mic malignant hyperthermia in the Early Stages of a Phase I Study Involving Patients with Recurrent Breast Cancer on the Chest Wall 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 reported that on May 16, 2007 at the joint meeting of the World Congress on Interventional Oncology and the Society for 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 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 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 (1) In object technology, the creation of self-contained modules that contain both the data and the processing. See object-oriented programming. (2) The transmission of one network protocol within another. 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 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 Cleveland Clinic (formally known as the Cleveland Clinic Foundation) is a multispecialty academic medical center located in Cleveland, Ohio, USA. Cleveland Clinic was established in 1921 by four physicians for the purpose of providing patient care, research, and medical , 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 United States, officially United States of America, republic (2005 est. pop. 295,734,000), 3,539,227 sq mi (9,166,598 sq km), North America. The United States is the world's third largest country in population and the fourth largest country in area. under an exclusive distribution agreement with Boston Scientific The Boston Scientific Corporation (NYSE: BSX) (abbreviated BSC), is a worldwide developer, manufacturer and marketer of medical devices whose products are used in a range of interventional medical specialties, including interventional cardiology, peripheral interventions, 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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