Celsion Co-sponsors Hepatocellular Carcinoma Symposium at the International Liver Cancer Association (ILCA) Annual Conference
The program was chaired by Ghassan Abou-Alfa, MD, MBA,
• | Prof. Riccardo Lencioni, MD, FSIR, EBIR |
Department of Radiology, University of Pisa, Italy | |
Hon. Res. Prof. Interventional Oncology | |
Miami Cancer Institute, Miami | |
• | Amit Singal, MD, MS |
Medical Director of Liver Tumor Program | |
Associate Professor of Medicine | |
UT Southwestern Medical Center, Dallas | |
• | Robin K. (Katie) Kelley, MD |
Associate Professor of Clinical Medicine | |
Helen Diller Family Comprehensive Cancer Center | |
Division of Hematology/Oncology | |
University of California, San Francisco |
Dr.
“ThermoDox® is being studied as the first potential curative treatment for HCC in a large, randomized, multicenter Phase III trial,” said Prof. Lencioni. “Post-hoc analyses of the Company’s first Phase III study of ThermoDox® – the HEAT Study – generated important findings that demonstrated its potential to significantly increase overall survival when target tissue is adequately heated with RFA for 45 minutes or longer. The Company’s ongoing second Phase III study, the OPTIMA Study, is designed to test this survival benefit hypothesis. If this hypothesis bears out in the OPTIMA Study, ThermoDox® will be the first and only
OPTIMA Study Update
Separately, the Company reports that the date for the independent data monitoring committee (iDMC) meeting to review the findings of the first pre-planned interim efficacy analysis of its Phase III OPTIMA Study has been scheduled for late October.
About ThermoDox®
Celsion’s most advanced program is a heat-mediated drug delivery technology that employs a novel heat-sensitive liposome engineered to address a range of difficult-to-treat cancers. The first application of this platform is ThermoDox®, a lyso-thermosensitive liposomal doxorubicin (LTLD), whose novel mechanism of action delivers high concentrations of doxorubicin to a region targeted with the application of localized heat at 40°C, just above body temperature. ThermoDox® is positioned for use with multiple heating technologies and has the potential to treat of a broad range of cancers including metastatic liver, recurrent chest wall breast cancer and non-muscle invading bladder cancers.
Celsion’s LTLD technology leverages two mechanisms of tumor biology to deliver higher concentrations of drug directly to the tumor site. In the first mechanism, rapidly growing tumors have leaky vasculature, which is permeable to liposomes and enables their accumulation within tumors. Leaky vasculature influences a number of factors within the tumor, including the access of therapeutic agents to tumor cells. Administered intravenously, ThermoDox® is engineered with a half-life to allow significant accumulation of liposomes at the tumor site as these liposomes recirculate in the blood stream. In the second mechanism, when an external heating device heats tumor tissue to a temperature of 40°C or greater, the heat-sensitive liposome rapidly changes structure and the liposomal membrane selectively dissolves, creating openings that can release a chemotherapeutic agent directly into the tumor and the surrounding vasculature. Drug concentration increases as a function of the accumulation of liposomes at the tumor site, but only where the heat is present. This method damages only the tumor and the area subject to tumor invasion, supporting more precise drug targeting.
About Celsion Corporation
Forward-looking Statements
Forward-looking statements in this news 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; the uncertainties of and difficulties in analyzing interim clinical data, particularly in small subgroups that are not statistically significant;
Celsion Investor Contact
Executive Vice President and CFO
609-482-2455
jchurch@celsion.com
Or
LHA Investor Relations
212-838-3777
kgolodetz@lhai.com
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Source: Celsion CORP