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Celsion Corporation (CLN) Announces Resubmission With Philips Healthcare of Combined IND/IDE Application for a Phase 2 Study of ThermoDox(R) and MR-Guided HIFU in Bone Cancer



5/14/2012 8:33:41 AM

LAWRENCEVILLE, NJ--(Marketwire - May 14, 2012) - Celsion Corporation (NASDAQ: CLSN), a leading oncology drug development company, today announced a joint resubmission with Philips Healthcare of an Investigational New Drug/Investigational Device Exemption (IND/IDE) application with the U.S. Food and Drug Administration (FDA) for a Phase 2 clinical study of Celsion's ThermoDox® combined with Philips' Sonalleve® MR-HIFU (MR-guided high intensity focused ultrasound) technology for the treatment of prostate cancer metastases to the bone. The companies expect to initiate the clinical study as soon as possible following FDA acceptance of the proposed program.

"Since we began our collaboration, both Celsion and Philips have understood the significant potential of combining ThermoDox® and HIFU," said Michael H. Tardugno, Celsion's President and Chief Executive Officer. "Many thought leaders believe that a multimodality approach is critical to the effective treatment of a variety of cancers. ThermoDox®, as a 'drop-in' therapy triggered only in the presence of heat, offers the ideal complement to potentially extend the menu of HIFU-based treatments. We look forward to completing our IND/IDE submission and, as we approach the outcome of our pivotal Phase III HEAT Study of ThermoDox® in primary liver cancer later this year, to initiating this Phase 2 study in metastases to the bone."

ThermoDox® combined with MR-HIFU will be investigated for pain palliation in patients with painful bone metastasis. Cancer progresses to the bone in a majority of patients with late-stage breast, prostate or lung cancer, with estimates of between 300,000 to 500,000 cases annually in the United States. Patients may experience excruciating and unrelenting pain, often treated with opiate drugs and NSAIDs (Non-Steroidal Anti-Inflammatory Drugs) with only modest benefit. External beam radiation therapy is effective in palliating painful bone metastasis, but is limited by accumulating toxic effects to normal organs. "A non-radioactive single-treatment therapy that acts quickly and brings significant pain relief to these debilitated patients would be a substantial step forward in the palliation of bone pain," said Nicholas Borys, MD, Celsion's Chief Medical Officer.

Philips' MR-HIFU system has the potential to precisely and non-invasively target lesions with acoustic energy, creating sufficient heat to activate ThermoDox® and preferentially release high concentrations of doxorubicin in the targeted treatment area. Celsion is developing the combination of ThermoDox® and HIFU through a joint research agreement with Philips Healthcare, a division of Royal Philips Electronics.

About ThermoDox® and Philips' Sonalleve® MR-HIFU

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 HEAT Study, ThermoDox® is administered intravenously in combination with 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 Philips Sonalleve® MR-HIFU system is currently available in Europe and some other countries for the treatment of uterine fibroids, a prevalent condition in women of childbearing age and palliative treatments to relieve pain associated with bone metastasis. It is not available for sale in the USA.

For more information about Philips' Sonalleve® MR-HIFU see: www.philips.com/sonalleve.

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 and the Beijing Cancer Hospital. 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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Argot Partners
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