SOURCE: Celsion Corporation

Celsion Corporation

February 13, 2012 08:00 ET

Celsion Announces First Patient Enrolled in Phase II Study of ThermoDox® in Combination With RFA in Colorectal Liver Metastases

This Study Will Capitalize on the Compelling Results From the Company's Phase I Dose Escalation Trial

LAWRENCEVILLE, NJ--(Marketwire - Feb 13, 2012) - Celsion Corporation (NASDAQ: CLSN), a leading oncology drug development company, announced today that the first patient has been enrolled in a randomized Phase II study of the Company's lead product candidate, ThermoDox®, a heat-activated liposomal encapsulation of doxorubicin, in combination with radiofrequency ablation (RFA) for the treatment of colorectal liver metastases (CRLM).

The multicenter Phase II study is expected to enroll up to 88 patients with colorectal cancer metastasized to the liver. Patients will be randomized to receive either RFA plus ThermoDox® or RFA alone for the treatment of their liver tumors. Dr. Steven K. Libutti, Professor and Vice Chairman, Department of Surgery and Director of the Montefiore-Einstein Center for Cancer Care at the Montefiore Medical Center and the Albert Einstein College of Medicine in New York City, will serve as the Lead Principal Investigator for the study. In addition to Montefiore, leading research institutions from North America will be included in the Phase II study. The primary study endpoint is based on one year local tumor recurrence, with secondary endpoints of time to progression and overall survival.

"The liver is a common site of metastases for cancers of the colon and rectum, as it provides a favorable environment for their growth and proliferation," stated Dr. Libutti. "Addressing these metastases allows us to improve three- and five-year survival rates among patients with this aggressive disease. While RFA can be effective in treating these tumors, it is often limited to smaller metastases within the liver. Adding ThermoDox® to RFA as adjuvant therapy is a combination which has demonstrated early clinical promise in treating larger tumors and multifocal disease. I look forward to understanding ThermoDox®'s promise in this larger outcome study."

In the Company's Phase I dose escalation study of 12 patients with non-resectable liver tumors, 8 of whom presented with CRLM, ThermoDox®, in combination with RFA, demonstrated tolerability and a significant dose response relationship. At three months, 45 of the 47 lesions met criteria for a complete response. While not a goal of the study, beyond six months, 16% of patients showed a complete response while 33% experienced a partial response. The maximum tolerated dose of ThermoDox® was established at 50 mg/m².

"Now that Celsion's Phase III HEAT Study of ThermoDox® in primary liver cancer has successfully completed its interim efficacy analysis, the expansion of our ThermoDox® program into other areas of promise is a priority for the Company," said Michael H. Tardugno, Celsion's President and Chief Executive Officer. "Colorectal cancer is among the most prevalent cancers worldwide, and a leading killer among cancers in Europe and the United States. Checking progression of this disease in the liver is an important clinical goal and the primary outcome measure of this study." Mr. Tardugno added: "CRLM represents a significant commercial opportunity, and we look forward to the results of this trial around the time ThermoDox® approaches registration, following a positive outcome in the HEAT Study."

About Colorectal Liver Metastases (CRLM)

The American Cancer Society estimates that there were over 141,000 new cases of colorectal cancer and about 51,000 colorectal cancer deaths in 2010. Up to 25% of patients with colorectal cancer present with liver metastases and another 50% develop liver metastases within 5 years. Median survival of patients with colorectal liver metastases (CRLM) is 6-12 months if untreated. While hepatic resection is potentially curative, most CRLM patients are inoperable and therefore radiofrequency ablation (RFA) is the most frequently used local treatment modality. Because RFA is both efficacious and widely accepted, a rational strategy is to attempt to increase its efficacy for medium (3.1-5.0 cm) and large ( > 5.0 cm) CRLM tumors with an adjuvant such as ThermoDox®.

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. 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.

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 its heat-activated liposomal drug technology. Celsion has research, license, or commercialization agreements with leading institutions such as the National Institutes of Health, Duke University, University of Hong Kong, the University of Pisa, and the UCLA Department of Medicine, Kyungpook National University Hospital and the Beijing Cancer Hospital.

For more information on Celsion, visit our website:

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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