Celsion Corporation (CLSN)

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Celsion Announces Collaboration With the University of Oxford to Design and Execute a Clinical Trial Using Ultrasound-Guided ...


Celsion Corporation (NASDAQ: CLSN), a leading oncology drug development company, today announced a collaboration with the University of Oxford to begin a clinical study of ThermoDox®, Celsion's heat-activated liposomal encapsulation of doxorubicin, in combination with ultrasound-guided High Intensity Focused Ultrasound (HIFU) to treat metastatic liver cancer. The early phase clinical study is being finalized and will require approval from a local Ethics Committee. Treatment of the first patient is targeted for late 2012.

"Both Celsion and Oxford believe there is significant potential of combining ThermoDox® with HIFU to treat cancer," said Michael H. Tardugno, Celsion's President and Chief Executive Officer. "A ThermoDox®/HIFU trial will be an important step in demonstrating that ultrasound-induced hyperthermia can enable the highly targeted delivery of chemotherapeutic agents to tumours non-invasively. ThermoDox® can effectively deliver high concentrations of a proven chemotherapy to a heated tumor. ThermoDox® may be used with multiple heating technologies allowing for us to target an even larger population of patients with cancer."

The trial, which is supported by the National Institute for Health Research (NIHR) Oxford Biomedical Research Centre, will be carried out as a multi-disciplinary collaboration between Celsion, the Oxford University Institute of Biomedical Engineering (Prof. Coussios), and the Oxford University Hospitals NHS Trust (Prof. Fergus Gleeson, Radiology, Prof. Mark Middleton, Oncology, and Dr. Tom Leslie, clinical HIFU Unit).

Professor Constantin-C. Coussios, Professor of Biomedical Engineering at the University of Oxford, commented, "This clinical program builds upon many years of experience with clinical ultrasound-guided HIFU, as well as laboratory studies of ThermoDox® release by ultrasound, at our institution. We look forward to exploring the addition of ThermoDox, a well-characterized anti-cancer therapy triggered only by heat, to HIFU, and the potential of this combination to advance treatment within a significantly underserved population."

About ThermoDox®

ThermoDox® is a proprietary heat-activated liposomal encapsulation of doxorubicin, an approved and frequently used oncology drug for the treatment of a wide range of cancers. In the Company's Phase III HEAT Study and Phase II ABLATE Study, ThermoDox® is administered intravenously in combination with Radio Frequency Ablation (RFA). Localized mild hyperthermia (39.5 - 42 degrees Celsius) created by the RFA releases the entrapped doxorubicin from the liposome. This delivery technology enables high concentrations of doxorubicin to be deposited preferentially in a targeted tumor.

The Company's Phase III HEAT Study, a randomized, double-blind, placebo-controlled clinical trial of ThermoDox® in combination with radiofrequency ablation (RFA) for the treatment of hepatocellular carcinoma (HCC), also known as primary liver cancer, is being conducted at 79 clinical sites under an FDA Special Protocol Assessment. The study is designed to evaluate the efficacy of ThermoDox® in combination with RFA when compared to patients who receive RFA alone as the control. The primary endpoint for the study is progression-free survival. The Company's Phase II ABLATE Study is being conducted at four clinical sites in the U.S. and is a randomized, blinded clinical trial of ThermoDox® in combination with RFA for the treatment of colorectal liver metastases with a PFS endpoint. Additional information on the Company's ThermoDox® clinical studies may be found at www.clinicaltrials.gov.

On May 30, 2012, Celsion announced that it had reached its enrollment objective of 700 patients in the HEAT Study. A total of 380 events of progression are required to reach the planned final analysis of the study which is estimated to occur in late 2012. Top line results will be announced following review by the Company's independent Data Monitoring Committee.

About Celsion Corporation

Celsion is a leading oncology company dedicated to the development and commercialization of innovative cancer drugs including tumor-targeting treatments using focused heat energy in combination with heat-activated liposomal drug technology. Celsion has research, license, or commercialization agreements with leading institutions including the National Institutes of Health, Duke University Medical Center, University of Hong Kong, the University of Pisa, the UCLA Department of Medicine, the Kyungpook National University Hospital, the Beijing Cancer Hospital and the University of Oxford.

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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