Celsion Reports Data Safety Monitoring Board Recommendation to Proceed to Phase II of the OVATION 2 Study in Advanced Ovarian Cancer - Seite 2

GEN-1 Population	PFS Hazard Ratio (Confidence Interval)
Intent-to-treat, n=15	0.53 (95% CI 0.16, 1.73); log-rank p=0.29
Per-protocol, n=14	0.33 (95% CI 0.08, 1.37); log-rank p=0.11

Patients in the GEN-1 arm virtually demonstrated a doubling of control of their cancer compared with the SCA. Findings are not statistically significant due to the small number of patients.

“These findings show a consistent dose dependent clinical response in both surgical outcome and tumor response. This is further supported by a series of translational data of the tumor microenvironment,” noted Dr. Nicholas Borys, Celsion’s executive vice president and chief medical officer. “Continuing our clinical research program at the higher, 100mg/m² dose, in this advance stage ovarian cancer population, holds promise and is strongly encouraged by our study investigators and medical advisors. We look forward to initiating enrollment as quickly as possible.”

“We are excited to be moving into the Phase II portion of the OVATION 2 Study, and thank the DSMB for their work and advice,” said Michael H. Tardugno, Celsion’s chairman, president and chief executive officer. “The recommendation to proceed at the highest dose and the fact patients were able to tolerate 17 doses bode well for study success, particularly in light of the body of positive data we have generated for GEN-1 in the advanced ovarian cancer indication. With no good treatment options available, we are hopeful GEN-1 will make a meaningful difference in the lives of these women. As previously announced, we plan to begin the Phase II study in the fourth quarter of this year.”

In March 2020, the Company announced that GEN-1 has received Orphan Drug Designation from the European Medicines Agency. Celsion plans to consult with the U.S. Food and Drug to request Fast Track review and potential Breakthrough Therapy designation for GEN-1 based on this encouraging clinical data.

About GEN-1 Immunotherapy

GEN-1, designed using Celsion's proprietary TheraPlas platform technology, is an IL-12 DNA plasmid vector encased in a nanoparticle delivery system, which enables cell transfection followed by persistent, local secretion of the IL-12 protein. IL-12 is one of the most active cytokines for the induction of potent anti-cancer immunity acting through the induction of T-lymphocyte and natural killer (NK) cell proliferation. The Company has previously reported positive safety and encouraging Phase I results with GEN-1 given as monotherapy in patients with peritoneally metastasized ovarian cancer, and recently completed a Phase Ib trial of GEN-1 in combination with PEGylated doxorubicin in patients with platinum-resistant ovarian cancer.