The Company anticipates completion of the Phase II US DIGNITY trial by year-end, and plans to initiate a 70 patient Phase II study in Europe and Israelin less advanced, less heavily pretreated patients as part of the Euro-DIGNITY Trial. The Euro-DIGNITY Trial will evaluate ThermoDox® plus radiation and hyperthermia in RCW breast cancer patients and is designed to support a registration filing in Europe. This study will be initiated throughoutEurope and Israel and with assistance from MedLogics Corporation, an Italian-based hyperthermia device company. In addition, Celsion has a license and distribution agreement with myTomorrows to implement an Early Access Program (EAP) for ThermoDox® in all countries of the European Unionterritory plus Switzerland for the treatment of patients with RCW breast cancer. The EAP provides physicians with access to products in later stage development demonstrating evidence of clinical benefit, with an acceptable safety profile and a quality manufacturing process in place.
The poster presentation is available on Celsion's website at http://investor.celsion.com/events.cfm.
Ad Statistics
Times Displayed: 112776
Times Visited: 6727 MIT labs, experts in Multi-Vendor component level repair of: MRI Coils, RF amplifiers, Gradient Amplifiers Contrast Media Injectors. System repairs, sub-assembly repairs, component level repairs, refurbish/calibrate. info@mitlabsusa.com/+1 (305) 470-8013
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; FDA and regulatory uncertainties and risks; the significant expense, time, and risk of failure of conducting clinical trials; 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.
