Celsion Corporation, an oncology drug development company, has announced the highlights from three presentations made by the principal investigators in the Company’s pivotal Phase III, global pivotal, double-blind, placebo-controlled OPTIMA Study of ThermoDox® in combination with standardized radiofrequency ablation (sRFA) in hepatocellular carcinoma (HCC).
ThermoDox® is Celsion’s proprietary therapy, consisting of intravenously delivered doxorubicin enhanced with lysolipid thermally sensitive liposomes that upon heating change structure, creating openings in the liposomes to release doxorubicin directly into the targeted tumor.
These results were presented at a symposium conducted at the International Liver Cancer Association (ILCA) 7th Annual Conference in Kyoto, Japan, and covered new paradigms in staging HCC patients, Phase III studies in HCC, and advances in image guided radiofrequency ablation.
In a study entitled “New Paradigms in Staging HCC: BCLC vs. Hong Kong Liver Cancer Staging System (HKLS)“, Ronnie T.P. Poon, MD, MS, PhD, FRCS (Edin), FACS, Professor of Surgery at the University of Hong Kong Queen Mary Hospital, Lead Asia Pacific Principal Investigator for Celsion’s Phase III OPTIMA Study and member of the ILCA Governing Board, discussed a more aggressive strategy for treating different stages of HCC, showing that combining sRFA with ThermoDox® may enhance the cure rate.
In another presentation titled “Phase III Studies in Intermediate Stage HCC: What Have We Learned From Recent Failures?“ Richard S. Finn, MD, faculty at the Division of Hermatology and Oncology and Director of the Translational Oncology Research Laboratory at UCLA, North American Principal Investigator for Celsion’s Phase III OPTIMA Study and member of the ILCA Governing Board, reviewed the latest results on Phase III clinical studies in intermediate stage HCC patients. Among them were data from Celsion’s Phase III HEAT Study, suggesting an enhanced overall survival (57% improvement) in ThermoDox® treated patients when heating cycles from the radio frequency ablation procedure were optimized.
Finally, a study titled “Image Guided Ablations: Current Status and Future Prospects” presented by Riccardo Lencioni, MD, FSIR, EBIR, Professor and Director of the Division of Diagnostic Imaging and Intervention at Pisa University School of Medicine in Pisa, Italy and Lead European Principal Investigator for Celsion’s Phase III OPTIMA Study, also highlighted results from the HEAT Study that suggest a crucial role to RFA and ThermoDox® in intermediate HCC if a 45 minute heating time is applied.
“Results from the HEAT Study, among the largest clinical trials conducted in primary liver cancer, highlight the important potential of ThermoDox® in this indication and underscores the need to standardize RFA with ThermoDox®. The HEAT Study clearly demonstrated that there is a place for RFA in treating intermediate HCC and standardizing RFA with ThermoDox®, as in Celsion’s OPTIMA Study, may be the key to a curative treatment for this deadly cancer.” said Professor Lencioni in a PR Newswire press release.