Celsion's ThermoDox® HEAT Study Findings Reviewed at the 2013 European Conference on Interventional Oncology (ECIO) in Budapest, Hungary on June 19 and 20, 2013
- Professor Lencioni's first presentation, titled "New Interventional Oncology Approaches in HCC; An Update on Clinical Trials" was held on
Wednesday, June 19, 2013 at2:30 p.m. (local time) in Plenary Session: Open Issues in the Management of Liver Cancer. This presentation is part of a joint symposium of the ECIO and theInternational Liver Cancer Association (ILCA). This special event will be chaired by Professor Lencioni (2013 ECIO Program Co-Chairman) and Dr.Joseph Llovet (ILCA President) - His second presentation, titled "Thermally Sensitive Doxorubicin Carriers" was held on
Thursday, June 20, 2013 at10:30 a.m. (local time) in Plenary Session: New Horizons in Interventional Oncology
"I am pleased to present this post-hoc analysis of a large subgroup of patients from the Phase III HEAT Study to the European and international interventional oncology community which may be indicating a meaningful clinical benefit in both progression free survival (PFS) and overall survival (OS) in patients who received an optimized RFA procedure," said Professor Lencioni. "It is important to note the duration of heat from the RFA procedure is a key factor in a successful clinical outcome when combined with ThermoDox®. These findings are consistent with our understanding that increased perfusion and associated heating time are important factors for ensuring that the heat-sensitive liposomes are activated to deposit high concentrations of doxorubicin in the tumor and the surrounding liver tissue."
The data from the HEAT Study post-hoc analysis presented by Professor Lencioni demonstrate that ThermoDox® markedly improves PFS and OS in patients with a single lesion if their lesions undergo RFA for 45 minutes or more. These findings apply to HCC lesions regardless of size and represent a subgroup of approximately 300 patients or 42% of the patients in the HEAT Study.
- In the patient subgroup treated in the ThermoDox® arm whose RFA procedure lasted longer than 45 minutes and was completed within 90 minutes (40% of single lesion patients) Overall Survival improved by 66% (Hazard Ratio of 0.602) when compared to the control arm of RFA treatment only.
- In the patient subgroup treated in the ThermoDox® arm whose RFA procedure lasted longer than 90 minutes (23% of single lesion patients), Overall Survival almost doubled (Hazard Ratio of 0.508) when compared to the control arm of RFA treatment only.
- When combined, these two subgroups show clinical results that indicated a 53% improvement in Overall Survival, a Hazard Ratio of 0.65, and a Pvalue = 0.105.
- In contrast, the patient subgroup treated with ThermoDox® whose RFA procedure lasted less than 45 minutes in duration (37% of single lesion patients) indicated that the control arm had an improved Overall Survival benefit when compared to the ThermoDox® arm.
- The Hazard Ratios reported above should be viewed with caution since they are not statistically significant and the HEAT Study has not reached its median point for Overall Survival analysis.
Celsion will continue following all patients enrolled in the HEAT Study to the secondary endpoint, Overall Survival, and update its subgroup analysis based on RFA heating duration.
Professor Lencioni's presentation is available on the Company's website at www.celsion.com under "News & Investor Info — Events & Presentations."
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