Celsion to commence Phase II Study of ThermoDox and RFA for CRLM

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."

SOURCE Celsion Corporation