COLUMBIA, Md., Jan. 21 /PRNewswire-FirstCall/ -- CELSION CORPORATION today announced the ThermoDox(R) liver cancer abstract "A Phase I Trial of ThermoDox in Patients Undergoing Radiofrequency Ablation (RFA) of Liver Tumors" has been accepted for oral presentation at the 9th World Congress of the International Hepato-Pancreato-Biliary Association (IHPBA) http://www.ihpba-ba2010.com/ to be held April 18-22, 2010, in Buenos Aires, Argentina.
In this Phase I study, ThermoDox was assessed for safety, pharmacokinetics and tumor response in 12 liver cancer patients (3 with hepatocellular carcinoma (HCC) and 9 with metastatic cancer). Patients were treated with ThermoDox (doses ranged from 30- 50mg/m2) during radiofrequency ablation (RFA), an accepted treatment procedure for unresectable liver tumors.
The rapid increase in primary liver cancer incidence worldwide, now at more than 650,000 cases, needs to be addressed by more aggressive treatments. ThermoDox is being studied as a potential first line treatment in combination with RFA in the pivotal Phase III HEAT trial. The study, which was agreed to under Special Protocol Assessment (SPA) guidance with the FDA provides progression free survival as its primary endpoint for accelerated review and is designed to demonstrate local tumor control with an overall survival benefit. The HEAT trial is a two arm, 1 to 1 randomized study comparing RFA with ThermoDox to SFA alone with a study population of 600 patients.
About ThermoDox
ThermoDox has demonstrated evidence of efficacy in a Phase I study for primary liver cancer and the FDA has granted Orphan Drug designation for this indication. For recurrent chest wall breast cancer, ThermoDox is being evaluated in a pivotal Phase I/II open-label, dose-escalating trial that is designed to measure durable local complete response at the tumor site.
About Primary Liver Cancer
About Celsion
For more information on Celsion, visit our website: http://www.celsion.com
Celsion Corporation
