"With an extremely high incidence rate of HCC in China, the compelling survival data from the Chinese subgroup analysis in the HEAT Study underscores the importance of further exploring the potential that exists for ThermoDox® in combination with sRFA to serve as a new curative treatment for primary liver cancer, a disease with limited treatment options," said Professor Min Hua Chen, MD, Chief Expert, Department of Ultrasonography, School of Oncology, Peking University, Lead Investigator for the OPTIMA Study in China, and former HEAT Study Investigator. "It is a great honor to be involved with the OPTIMA Study, and I look forward to working with Celsion and my research colleagues as the study progresses."
The primary endpoint for the OPTIMA Study is overall survival (OS). The statistical plan calls for two preplanned interim efficacy analyses by an independent Data Monitoring Committee (iDMC). The design of the OPTIMA Study is supported by a retrospective analysis of a large subgroup of 285 patients in the Company's previous 701 patient HEAT Study in primary liver cancer. In a subgroup of 285 HEAT Study participants, ThermoDox® plus standardized RFA demonstrated a statistically significant improvement in survival of over two years compared to standardized RFA alone. In this large subgroup, the median overall survival in the ThermoDox® plus standardized RFA arm was approximately 80 months (6 ½ years), which is considered a curative treatment for HCC.
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About Celsion Corporation
Celsion is a fully-integrated oncology company focused on developing a portfolio of innovative cancer treatments, including directed chemotherapies, immunotherapies and RNA- or DNA-based therapies. The Company's lead program is ThermoDox®, a proprietary heat-activated liposomal encapsulation of doxorubicin, currently in Phase III development for the treatment of primary liver cancer and in Phase II development for the treatment of recurrent chest wall breast cancer. The pipeline also includes GEN-1, a DNA-based immunotherapy for the localized treatment of ovarian and brain cancers. Celsion has two platform technologies for the development of novel nucleic acid-based immunotherapies and other anti-cancer DNA or RNA therapies, including TheraPlas™ and TheraSilence™. For more information on Celsion, visit our website: http://www.celsion.com.
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