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Please view the latest news articles from across Europe below. Alternatively, filter by news category or search by keyword.Celsion Plans To Launch Phase II Program To Study ThermoDox(R) In Combination With RFA For Colorectal Liver Metastases
Celsion Corporation (Nasdaq: CLSN) 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 at the Montefiore Medical Center 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."
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The information provided is for interest only and is not a substitute for professional medical advice. You should not rely on this information to make or refrain from making any decisions. Always obtain independent professional advice for your own particular health situation.
