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Celsion Receives COMP Recommendation for Orphan Drug Designation in Europe for ThermoDox® to Treat Primary Liver Cancer
Date:11/11/2010

Celsion's President and Chief Executive Officer.  "This positive opinion on our application for orphan designation status is an acknowledgement of the significant unmet medical need to develop a new treatment for patients with primary liver cancer, a life threatening disorder for which today there is no effective chemotherapeutic standard of care.  Centralized approval provides for rapid commercialization across the European Union.  We look forward to continuing our positive interactions with the EMA, the FDA and other regulatory agencies around the world to make ThermoDox® available to patients as soon as possible."

Regulatory agencies around the world, as well as the liver cancer medical community, have all recognized the potential of ThermoDox® for the treatment of this unmet medical need as evidenced by the following:

  • Orphan Drug designation for ThermoDox® by the FDA and a positive opinion by the COMP for similar designation in Europe;
  • The HEAT study has been granted a Fast Track Designation by the FDA; and
  • The National Cancer Institute's recent designation of the HEAT study as a Priority Clinical Trial at its recent Clinical Trial Planning Meeting for HCC.

  • About Primary Liver CancerPrimary liver cancer is one of the most deadly forms of cancer and ranks as the fifth most common solid tumor cancer.   The incidence of primary liver cancer is approximately 20,000 cases per year in the United States, approximately 40,000 cases per year in Europe and is rapidly growing worldwide at approximately 750,000 cases per year, due to the high prevalence of Hepatitis B and C in developing countries.  The standard first line treatment for liver cancer is surgical resection of the tumor; however 80% to 90% of patients are ineligible for surgery.  Radio frequency ablation (RFA) has increasing become the standard of care for non-resectable liver tumors, but the treatment becomes less effe
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    SOURCE Celsion Corporation
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