LAWRENCEVILLE, N.J., March 7, 2016 /PRNewswire/ -- Celsion Corporation (NASDAQ: CLSN), a fully-integrated oncology company focused on the development of a portfolio of innovative cancer treatments, today announced the launch of the OPTIMA Study in China. The Company held an Investigators' Meeting for the OPTIMA Study on March 5, 2016 in Shanghai, China. Professor Ronnie T.P. Poon, MD, MBBS, MS, PhD, FRCS (Edin), FACS, Medical Director at the Hong Kong Integrated Oncology Center, Honorary Professor of Surgery at the University of Hong Kong Queen Mary Hospital, and member of the International Liver Cancer Association (ILCA) Governing Board provided the Keynote Address entitled "Treatment Strategies for Early/Intermediate HCC." Professor Poon discussed strategies for treating different stages of primary liver cancer, also known as hepatocellular carcinoma (HCC); including intermediate stage HCC which has been previously thought to be incurable. New treatment strategies, most notably an optimized RFA procedure with the investigational drug, ThermoDox®, show clear promise as a potential cure for intermediate HCC in the years ahead. Investigators and their staff from 20 sites in mainland China andHong Kong were in attendance. The OPTIMA Study is the Company's global pivotal, double-blind, placebo-controlled trial, evaluating ThermoDox®, Celsion's proprietary heat-activated liposomal encapsulation of doxorubicin, in combination with radiofrequency ablation standardized to 45 minutes (sRFA) versus sRFA alone to treat newly diagnosed patients with HCC.
"Following a very successful Investigator's startup meeting in Shanghai this past weekend, we are eager to accelerate site initiation and patient enrollment, and expect to complete the process already underway by the end of the second quarter," said Michael H. Tardugno, Celsion's chairman, president and chief executive officer. "Our researchers and principal investigators recognize the importance of the OPTIMA Study to the medical community and its potential to significantly improve overall survival of newly diagnosed HCC patients. With approximately 50% of the 850,000 new cases of primary liver cancer diagnosed each year originating in China, China represents a significant market opportunity and key element of our global development strategy for ThermoDox®."
The Phase III OPTIMA Study is expected to enroll up to 550 patients globally, and has been successfully enrolling patients at 50 clinical sites in 12 different countries in North America, Europe and Asia Pacific. InDecember 2015, the Company announced that it had received a Clinical Trial Application (CTA) approval from the China Food and Drug Administration (CFDA) to conduct the ongoing Phase III OPTIMA Study at up to 20 additional clinical sites in China. The Company aims to enroll more than 200 patients in the Chinaterritory, the minimum number required by the CFDA to file a New Drug Application (NDA), assuming positive clinical results.
"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.
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.
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; the uncertainties of and difficulties in analyzing interim clinical data, particularly in small subgroups that are not statistically significant; FDA and regulatory uncertainties and risks; the significant expense, time, and risk of failure of conducting clinical trials; the need for Celsion to evaluate its future development plans; possible acquisitions or licenses of other technologies, assets or businesses; possible actions by customers, suppliers, competitors, regulatory authorities; and other risks detailed from time to time in the Celsion's periodic reports and prospectuses filed with the Securities and Exchange Commission. Celsion assumes no obligation to update or supplement forward-looking statements that become untrue because of subsequent events, new information or otherwise.
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