Celsion Corporation Reports Third Quarter 2016 Financial Results And Provides Business Update

Meaningful Progress with the ThermoDox® OPTIMA Study and GEN-1 Immunotherapy Program, Including Highly Encouraging Data from Primary Liver and Ovarian Cancer Studies

Company to Hold Conference Call Today, November 10, 2016 at 11:00 a.m. ET

LAWRENCEVILLE, N.J., Nov. 10, 2016 (GLOBE NEWSWIRE) -- Celsion Corporation (NASDAQ:CLSN), an oncology drug development company, today announced financial results for the quarter and nine month period ended September 30, 2016 and provided an update on its development programs for ThermoDox®, the Company's proprietary heat-activated liposomal encapsulation of doxorubicin and GEN-1, an IL-12 DNA-based immunotherapy.

"Over the last nine months, we have realized meaningful progress with respect to our two lead programs, ThermoDox® and GEN-1.  Importantly, we are well positioned to sustain this momentum through the balance of 2016 and beyond," said Michael H. Tardugno, Celsion's chairman, president and CEO. "The initial data from our GEN-1 program provides highly valuable insights into its favorable clinical and safety profile indicating a great deal of potential in both first and second-line ovarian cancer, and we look forward to reporting additional data from our ongoing OVATION study before year-end."

Mr. Tardugno continued, "Our ongoing global, pivotal Phase III OPTIMA Study of ThermoDox® in primary liver cancer remains on track with clinical sites currently enrolling patients in 13 countries worldwide. Investigators continue to recognize the value of findings from the HEAT Study and their continued interest reinforces substantial and mounting support for the OPTIMA Study. The recent independent analysis conducted by the National Institutes of Health provides further confirmatory support indicating that the use of radiofrequency ablation (RFA) for more than 45 minutes in patients treated with ThermoDox® can have a correlative impact on reductions in tumor size and overall survival in patients with primary liver cancer."

Recent Developments

Immunotherapy - GEN-1

Announced Positive Data from the First Two Cohorts of the OVATION Study.  In July 2016, the Company announced data from the second cohort of patients in its Phase Ib dose escalating clinical trial (the OVATION Study) combining GEN-1 with the standard of care for the treatment of newly-diagnosed patients with advanced ovarian cancer who will undergo neoadjuvant chemotherapy followed by interval debulking surgery. In the first six patients dosed, GEN-1 plus standard chemotherapy produced impressive results, with no dose limiting toxicities and highly promising efficacy signals in this difficult-to-treat cancer. The efficacy data included highly encouraging tumor response rates, successful surgical resections of the eligible patients' tumors, impressive pathological responses and dramatic, clinically meaningful drops in CA-125 protein levels. 

Positive DSMB Review of OVATION Study in Ovarian Cancer.  In September 2016, the independent Data Safety Monitoring Board (DSMB) completed its safety review of data from the first three patient cohorts in the ongoing Phase Ib OVATION Study.  Based on the DSMB's recommendation, the study will continue as planned and the Company will proceed with dosing in its fourth and final patient cohort at an escalated dose.  Celsion expects the fourth cohort to be fully enrolled this year.

Established a Manufacturing and Commercial Supply Agreement with Hisun for GEN-1.  In August 2016, Celsion signed a long term technology transfer, manufacturing and commercial supply agreement with Zhejiang Hisun Pharmaceutical Co. Ltd.  The agreement relates to both the clinical and commercial manufacture and supply of GEN-1 for the greater China territory, with the option to expand into other countries in the rest of the world after all necessary regulatory approvals are in effect. With highly cost effective pricing, the agreement will support economically advantaged supply for ongoing and planned clinical studies in the United States and potential future studies of GEN-1 in China as well as Europe. 

Chemotherapy - ThermoDox®

Announced the Final Overall Survival Data from HEAT Study of ThermoDox® in Primary Liver Cancer.  In August 2016, the Company announced updated results from its final retrospective analysis of the 701-patient HEAT Study.  The overall survival analysis demonstrated that in a large, well bounded, subgroup of 285 patients (41% of the HEAT Study patients), treatment with a combination of ThermoDox® and optimized RFA provided an average 54% risk improvement in overall survival compared to optimized RFA alone. The Hazard Ratio (HR) at this analysis is 0.65 (95% CI 0.45 - 0.94) with a p-value of 0.02.  Importantly, after 3.5 years of follow up, the median overall survival for the ThermoDox® group has yet to be reached and is showing over 80 months survival benefit compared to less than 60 months projection for the optimized RFA only group, which translates into a two year survival benefit.

Announced the Independent NIH Analysis Showing Treatment with ThermoDox® Plus RFA may Significantly Improve Overall Survival of Patients with Primary Liver Cancer.  In September 2016, the Company announced that the National Institutes of Health (NIH) has conducted an independent retrospective analysis of data from the Company's HEAT Study.  The NIH analysis, which sought to evaluate the correlation between RFA burn time per tumor volume (min/ml) and clinical outcome in patients treated with ThermoDox®, concluded that increased RFA burn time per tumor volume substantially improved survival in patients with solitary lesions treated with RFA + ThermoDox® compared to patients treated with RFA alone.  These findings are consistent with Celsion's analysis of the HEAT Study data showing that in patients treated with RFA for more than 45 minutes, standardized RFA plus ThermoDox® resulted in a statistically significant improvement in overall survival of over two years when compared to standardized RFA alone. 

Detailed findings from the NIH study will be presented during oral sessions on Monday, November 28, 2016 at 1:50 pm CT during the 102 nd Scientific Assembly and Annual Meeting of the Radiological Society of North America (RSNA) to be held on November 26 - December 2, 2016 in Chicago, IL.

Announced Presentations Highlighting Phase III OPTIMA Study at Two Asia-Pacific Primary Liver Cancer Expert Meetings. 

In July 2016, the Company announced that its ongoing Phase III OPTIMA trial evaluating ThermoDox® in primary liver cancer was featured during an oral presentation at the 7th Asia-Pacific Primary Liver Cancer Expert (APPLE) Meeting in Hong Kong, China.  The presentation highlighted the potential of ThermoDox® plus optimized RFA to significantly improve overall survival of newly diagnosed patients.

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