Celsion Corporation (Nasdaq: CLSN) announced today that the consensus recommendations of the National Cancer Institute (NCI) Clinical Trials Planning Meeting (CTPM) for Hepatocellular Carcinoma have been released and published in the August 2010 issue of Journal of Clinical Oncology, the official publication of American Society of Clinical Oncology (ASCO). In addition to evaluating the current standard of care, the NCI panel also recommended Celsion's Phase III ThermoDox ® HEAT Study as a Priority Clinical Trial for HCC.
"We are pleased this prominent panel of experts at the NCI Clinical Trials Planning Meeting have recognized the importance of our Phase III HEAT Study," stated Michael H. Tardugno, President and Chief Executive Officer of Celsion. "Upon completion of the trial and eventual marketing approval, ThermoDox plus RFA will provide an additional therapeutic option for patients afflicted with HCC, a dreadful disease with high unmet medical need." Dr. Nicholas Borys, Chief Medical Officer of Celsion Corporation commented, "This JCO article also reinforces the global importance of new therapies for HCC, and highlights the prominence of the ThermoDox program, which is now over 2/3rds enrolled in 75 global sites and 11 countries."
Celsion's global Phase III ThermoDox study for primary liver cancer plans to enroll 600 patients and is being conducted under a FDA Special Protocol Assessment (SPA). The study is designed to evaluate the efficacy of ThermoDox in combination with radiofrequency ablation (RFA) when compared to patients who receive RFA alone as the control. The primary endpoint for the study is progression-free survival. Additional information on the Phase III ThermoDox clinical study may be found at www.clinicaltrials.gov.
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