COLUMBIA, Md., March 1 Celsion Corporation (Nasdaq: CLSN) today announced that it will initiate a Randomized Phase II Study of Lyso-Thermosensitive Liposomal Doxorubicin (ThermoDox®) and Radiofrequency Ablation (RFA) for Colorectal Liver Metastases (CRLM). Dr. Steven K. Libutti, Professor and Vice Chairman, Department of Surgery and Director of the Montefiore-Einstein Center for Cancer Care and Albert Einstein College of Medicine in New York City, will serve as Principal Investigator for the study. In addition to Montefiore Medical Center, at least 2 other leading research institutions from North America and the Asia Pacific region (including Japan) will be included in the Phase II study, which is expected to commence in the second half of 2010. The study is meant to address the growing unmet medical need of colorectal liver metastases, which is globally prevalent and is currently treated by radiofrequency ablation.
"Celsion Corporation first began studying ThermoDox in combination with RFA for liver metastases in a Phase I safety study of 24-patients, 15 of which had liver metastases from 9 primary sites, including CRLM," said Michael Tardugno, President and CEO of Celsion. "The safety experience and dose response relationship we witnessed in the Phase I study was evident in both primary and metastatic tumors. Building upon this data, we have made the decision to pursue a randomized Phase II study. CRLM is an indication which we believe has a large addressable market, and we expect that CRLM will be a label extension to hepatocellular carcinoma, increasing the value of ThermoDox."
"Having previously studied ThermoDox and completed the Phase I study, I felt the CRLM indication must be further investigated," said Dr. Steven K. Libutti, a prominent expert in treating liver cancer metastases. "There is a large unaddressed population here in North America, and I believe ThermoDox may play a role in treating liver metastases, particularly for larger tumors where survival rates are poor. We believe we are well positioned to conduct this study given the outstanding clinicians and our vast experience in clinical trial research at the Montefiore-Einstein Center for Cancer Care."
ThermoDox in combination with hyperthermia or ablation has the potential to provide local tumor control, extending and improving the quality of life. 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 including breast cancer and liver cancer. Localized mild hyperthermia (40-42 degrees Celsius) releases the entrapped doxorubicin from the liposome. This delivery technology enables high concentrations of doxorubicin to be deposited preferentially in a targeted tumor.
For primary liver cancer, ThermoDox is being evaluated in a 600-patient global Phase III study at 70 clinical sites under an FDA Special Protocol Assessment. The primary endpoint for the study is progression-free survival and enrollment is expected to be completed in 2010. For recurrent chest wall breast cancer, ThermoDox is being evaluated in a Phase I/II open-label, dose escalating trial that is 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. Additional information on these ThermoDox clinical studies may be found at www.celsion.com.
ThermoDox® is a registered trademark of Celsion Corporation
About Colorectal Liver Metastases (CRLM)
The American Cancer Society estimates that there were about 147,000 new cases of colorectal cancer and about 50,000 colorectal cancer deaths during 2009. 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 for CRLM. 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 Celsion Corporation
Celsion is dedicated to the development and commercialization of innovative oncology drugs including tumor-targeting treatments using focused heat energy in combination with heat activated drug delivery systems. Celsion has licensed ThermoDox(R) to Yakult-Honsha for the Japanese market and has a partnership agreement with Philips Healthcare to jointly develop its heat activated liposomal technology in combination with high intensity focused ultrasound to treat difficult cancers. 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, and the North Shore Long Island Jewish Health System. 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.
Investor Contact Tricia Swanson The Trout Group 617-583-1306 firstname.lastname@example.org
SOURCE Celsion Corporation