Celsion Commences Pivotal Phase I/II Study Of ThermoDox(R) In The Treatment Of Recurrent Chest Wall Breast Cancer

Celsion Corporation (NASDAQ: CLSN), an oncology company dedicated to the development and commercialization of therapies for difficult-to-treat cancers, announced today that it has initiated a pivotal Phase I/II study of ThermoDox® in combination with hyperthermia, or heat, to treat recurrent chest wall breast cancer, a disease with a very poor patient prognosis and limited treatment options.


The open-label, dose-escalating pivotal trial has been designed to measure durable local complete response at the tumor site. Celsion expects to enroll approximately 100 patients across the United States and to complete the study by the first half of 2010. Study locations include the Florida Cancer Institute in Hudson, FL led by Principal Investigator Arthur Maztkowitz, MD, New York University Hospital in New York, NY led by Silvia Formenti, MD, and the Cancer Treatment Center of America in Tulsa, OK led by Petra Ketterl, MD. Additional information on the study may be found at clinicaltrials.


Michael H. Tardugno, Celsion's President and Chief Executive Officer, commented "We are pleased to update our partners, particularly our shareholders, on the significant progress that has been made on our recurrent chest wall cancer program just three months after submitting our final protocol to the FDA. The clinical staff has brought us one step closer to delivering on the potential of ThermoDox to a cancer population that is truly in need of effective treatment options, given the debilitating nature of this disease, and we are extremely proud of their hard work and commitment to this initiative."


"Recurrent cancer at the chest wall can affect a significant number of breast cancer patients who have had a mastectomy", noted Dr. Nicholas Borys, Celsion's VP and Chief Medical Officer. "With no current standard of care, women with this type of recurrence often cannot be adequately treated with surgery, radiation, or existing chemotherapy. We believe that the DIGNITY study will demonstrate that ThermoDox in combination with hyperthermia will provide local tumor control and improve quality of life."


About Recurrent Chest Wall Cancer


Depending on risk factors, up to 40% of women with mastectomies may experience recurrent chest wall cancer (RCW). The disease is generally defined as the recurrence of tumor to the area of the initial definitive treatment such as mastectomy. There are a significant number of women diagnosed with RCW who frequently cannot be treated with further surgical resection, radiation or existing chemotherapy because they have exhausted available treatment options.


About ThermoDox®


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. Localized heat (at 40-42 degrees Celsius and above) releases the entrapped doxorubicin from the liposome. This delivery technology enables high concentrations of doxorubicin to be deposited preferentially in a targeted tumor.


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.


For more information on Celsion, visit our website: celsion.


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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