On October 6, 2015 Celsion Corporation (NASDAQ: CLSN), an oncology drug development company, reported the upcoming presentations of data supporting the Company’s ongoing pivotal phase III OPTIMA Study of ThermoDox, its proprietary heat-activated liposomal encapsulation of doxorubicin in combination with optimized radiofrequency ablation (RFA) for the treatment of intermediate primary liver cancer (Press release, Celsion, OCT 6, 2015, View Source [SID:1234507651]). The data will be presented on October 30-31, 2015 at the 2015 Asian Conference on Tumor Ablation (ACTA) in Fukuoka, Japan by two leading liver cancer experts from South Korea and Taiwan, Professor Won Young Tak, MD, Ph.D., Division of Gastroenterology and Hepatology, Department of Internal Medicine, School of Medicine, Kyungpook National University, Daegu, Republic of Korea and Dr. Shi-Ming Lin, MD, co-chair ACTA 2015 and vice chairman, Department of Gastroenterology and Hepatology, Chang Gung Memorial Hospital, Taipei, Taiwan. Professor Tak’s presentation will highlight ThermoDox in an oral presentation during the Plenary Lecture Session: "Top Tips for the Liver Tumor Ablation".

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"Data underscoring the value of ThermoDox in combination with RFA therapy as a potentially curative treatment for primary liver cancer, a disease with limited treatment options, will be presented once again at an internationally recognized medical conference. ILCA, WCIO, ECIO, ASCO (Free ASCO Whitepaper), and now ACTA have each provided a forum for liver cancer thought leaders to discuss the promise of ThermoDox with leading physicians and scientists from the global oncology community. Medical, surgical and interventional oncologists from N. America, Asia, and Europe have endorsed our pivotal phase III OPTIMA Study, now ongoing in 11 counties worldwide," said Michael H. Tardugno, Celsion’s chairman, president and chief executive officer. "It is a privilege to now have Professor Tak along with Dr. Lin, two internationally recognized liver cancer experts who have comprehensive experience with ThermoDox as a result of their deep involvement in Celsion’s HEAT Study, present these findings."

The three presentations include:

"Effect of Radiofrequency Ablation (RFA) Dwell Time (+/-) ThermoDox on Safety and Overall Survival (OS) Among 452 Intermediate Solitary HCC Patients With Lesions 3 to 7 cm: HEAT Study Data," by Professor Won Young Tak, MD, Ph.D., Division of Gastroenterology and Hepatology, Department of Internal Medicine, School of Medicine, Kyungpook National University, Daegu, Republic of Korea and lead investigator in South Korea for the Company’s HEAT and OPTIMA studies. Professor Tak will discuss data from Celsion’s latest HEAT Study post-hoc analysis, which suggests an overall survival benefit of over two years in the large subgroup of patients treated with ThermoDox plus optimized RFA (RFA > 45 minutes).
"Effect of Standardizing Radiofrequency Ablation and Lyso-Thermosensitive Liposomal Doxorubicin (LTLD, ThermoDox) on Overall Survival (OS) Among Patients with a Solitary 3 to 7 cm HCC Lesion: A HEAT Study Multivariate Analysis," by Dr. Shi-Ming Lin, MD, co-chair ACTA 2015, vice-chairman, Department of Gastroenterology and Hepatology, Chang Gung Memorial Hospital, Taipei, Taiwan, and lead investigator in Taiwan for the Company’s HEAT and OPTIMA studies. Dr. Lin will review the extensive data from Celsion’s HEAT Study, including the results of multivariate analyses performed which clearly suggests that RFA heating or dwell time greater than 45 minutes was the only statistically significant variable that explained the significant improvement in overall survival (79 months in the optimized RFA plus ThermoDox subgroup versus 53.6 months in the optimized RFA only subgroup) in a large, well bounded subgroup of 285 patients (41% of the HEAT Study patients).
"Importance of Heating Time on the Local Drug Deposition During RFA in Combination with Lyso-Thermosensitive Liposomal Doxorubicin (LTLD) in a Porcine Model," by Nicholas Borys, MD, Celsion’s senior vice president and chief medical officer. Dr. Borys will review findings from a preclinical study demonstrating that in a porcine model, a direct correlation was observed between the duration of RFA heating, or dwell time, and the concentration of doxorubicin localized to the liver.
The presentations will be available on Celsion’s website at View Source