ThermoDox HEAT study results to be presented at ILCA 2013

Ronnie TP Poon

Celsion Corporation announced that Ronnie TP Poon, professor of Surgery at the University of Hong Kong and lead Asia Pacific principal investigator for the company’s phase III HEAT study of ThermoDox in hepatocellular carcinoma will present the official clinical trial results from the HEAT study at the International Liver Cancer Association (ILCA) 7th annual conference (September 13–15 Washington DC, USA).

The presentation will include the most recent overall survival data. Recent HEAT study post-hoc analysis, strongly suggest positive progression-free survival and overall survival in ThermoDox treated patients when heating cycles from the radiofrequency ablation procedure were optimised.

Celsion has conducted a comprehensive analysis of the data from the phase III HEAT study of ThermoDox in primary liver cancer. Subgroup analysis based on radiofrequency heating duration continues to suggest that ThermoDox markedly improves overall survival, when compared to the control group, in patients if their lesions undergo radiofrequency ablation for 45 minutes or more. These findings apply to single hepatocellular carcinoma lesions (63% of the HEAT study population) from both size cohorts of the HEAT Study (3–5cm and 5–7cm) and represent approximately 300 patients.

Poon’s oral presentation is titled “Phase 3 randomised, double-blind, dummy-controlled trial of radiofrequency ablation plus lyso-thermosensitive liposomal doxorubicin for hepatocellular carcinoma lesions 3–7cm”. It will also be webcast as part of an online educational programme from the conference. 

Following the presentation on 14 September at the plenary session, Celsion is sponsoring a symposium of leading liver cancer experts to discuss new directions in the treatment of early-intermediate hepatocellular carcinoma.

Celsion is also sponsoring a symposium in conjunction with the ILCA conference, moderated by Riccardo Lencioni, director of the Division of Diagnostic Imaging and Intervention, Pisa University School of Medicine, Italy. The discussion will focus on a review of new developments in the treatment of early to intermediate hepatocellular carcinoma and discuss updated data from the HEAT Study post-hoc analysis. 

In May 2013, Lencioni told delegates at the World Conference on Interventional Oncology (WCIO) conference in that radiofrequency was the standard technique for image-guided ablation of early stage hepatocellular carcinoma. He noted that while novel technologies such as microwave ablation and irreversible electroporation seemed to offer advantages over radiofrequency, they also needed accurate investigation in clinical trials. Lencioni said that clinical research on potential synergies between image-guided local ablation and new drugs/new carrierswas ongoing.