On February 4, 2020 Celsion Corporation (NASDAQ: CLSN), an oncology drug-development company, reported Prof. Riccardo Lencioni, M.D., FSIR, EBIR delivered a presentation titled "Thermally-Sensitive Ablation Enhancers: Where Do We Stand?" at the SPECTRUM 2020 Interventional Oncology Conference held in Miami , FLA last month (Press release, Celsion, FEB 4, 2020, View Source [SID1234553840]). Dr. Lencioni is a professor in the Department of Radiology at the University of Pisa School of Medicine in Italy and is an Honorary Research Professor of Interventional Oncology at the Miami Cancer Institute. He was the lead principal investigator in Europe for the Company’s completed Phase III HEAT Study in hepatocellular carcinoma (HCC), or primary liver cancer, using radiofrequency ablation (RFA) plus ThermoDox, the Company’s lead product.

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The SPECTRUM Conference is the only interventional oncology conference endorsed by The American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper). In his talk, Prof. Lencioni focused on the HEAT Study subgroup analysis showing the duration of RFA heating time per tumor volume of 45 minutes or longer plus ThermoDox was key to overall survival benefit in this patient population. He noted that in early-stage HCC, nearly 50% of patients with a solitary lesion of less than 5 cm on imaging have microsatellites on histology. While RFA and other energy sources are not able to treat these microsatellites, a thermosensitive drug carrier such as ThermoDox would deposit increased amounts of doxorubicin in the margins of a tumor given increased ablation time.

"The significant attention ThermoDox is receiving among key opinion leaders at important medical conferences has helped build awareness of our drug in combination with RFA for treating HCC," said Michael H. Tardugno, Celsion’s chairman, president and chief executive officer. "We are grateful to Prof. Lencioni for helping Celsion create the training video on RFA heating time for lesion sizes from 3 cm to 7 cm that is being used by all investigators in our current Phase III OPTIMA Study."

The Company’s OPTIMA Study was based on the prospective analysis of the HEAT Study subgroup of patients who received 45 minutes or more of RFA energy. The OPTIMA Study was fully enrolled in August 2018 with 556 subjects from 65 clinical sites in 14 countries. At its first interim analysis in November 2019 following 128 patient events, or deaths, the independent Data Monitoring Committee (iDMC) unanimously recommended the OPTIMA Study continue according to protocol based on safety and data integrity.

The Company re-affirms its projection that its second pre-planned interim efficacy analysis will occur during the second quarter of 2020, following 158 patient events, or deaths. The hazard ratio for success at 158 events is 0.70, which is below the hazard ratio of 0.65 observed for the 285 patients in the HEAT Study subgroup of patients treated with RFA of 45 minutes or longer.

Mr. Tardugno added, "We were pleased that the HCC part of the SPECTRUM program featured invited faculty with ties to Celsion, such as Dr. Josep Llovet, Founder and Director of the Liver Cancer Program and Full Professor of Medicine at the Mount Sinai School of Medicine in New York, who is chair of the OPTIMA iDMC, and Dr. Ghassan Abou-Alfa of Memorial Sloan Kettering Cancer Center and Professor, Weill Medical College at Cornell University, both in New York City, who was a member of the HEAT Study DMC. The medical community’s independent assessment, along with the National Institutes of Health’s published confirmation of the hypothesis supporting the potential for ThermoDox as a curative treatment for the largest unmet need in oncology is gratifying indeed."