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Data Monitoring Committee Unanimously Recommends Continuation of Celsion's Phase III ThermoDox® HEAT Study to Treat Primary Liver Cancer
Date:9/30/2010

validity of the trial design.  The trial design and statistical plan for the HEAT study also incorporates a pre-planned interim efficacy analysis by the DMC (after patient enrollment is complete and 190 progression-free survival events are realized in the study population) with the intent of evaluating safety and efficacy results to determine if there is overwhelming evidence of clinical benefit or a low probability of treatment success (a futility analysis) to continue, modify or terminate the trial.

"We are very pleased that the DMC has unanimously recommended continuation of the HEAT study based on its review of all available clinical data, both safety and efficacy, in over 400 patients," stated Mr. Michael H. Tardugno, Celsion's President and Chief Executive Officer.  "The DMC's affirmative review is further evidence of ThermoDox's potential to provide a first line of chemotherapy for the treatment of primary liver cancer."

The National Institutes of Health and 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:

  • HEAT study is being conducted under a Special Protocol Assessment with the FDA;
  • 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 and has a worldwide incidence of approximately 650,000 cases, due to the high prevalence of Hepatitis B and C in developing countries.  The standard first line treatment for liver cancer is surgi
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    SOURCE Celsion Corporation
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