Celsion receives FDA Fast Track Designation for GEN-1

Celsion Corporation announced that it has received Fast Track designation from the U.S. Food and Drug Administration for GEN-1, its DNA-mediated interleukin-12 immunotherapy currently in Phase II development for the treatment of advanced ovarian cancer. GEN-1 was designed using TheraPlas, Celsion's proprietary, synthetic, non-viral nanoparticle delivery system platform. GEN-1 is the subject of Celsion's Phase II OVATION 2 Study, which combines GEN-1 with standard-of-care neoadjuvant chemotherapy in patients newly diagnosed with Stage III/IV ovarian cancer. NACT is designed to shrink the cancer as much as possible for optimal surgical removal after three cycles of chemotherapy. Following NACT, patients undergo interval debulking surgery, followed by three adjuvant cycles of chemotherapy and up to nine additional weekly GEN-1 treatments, the goal of which is to delay progression and improve overall survival. The OVATION 2 Study is an open-label, 1-to-1 randomized trial, 80% powered to show the equivalent of a 33% improvement in progression-free survival, the primary endpoint, when comparing the treatment arm with the control arm. As Celsion has previously announced, it has shared with the FDA data from the Phase I portion of the Phase I/II OVATION 2 Study that showed successful tumor resections, with seven out of eight patients in the GEN-1 treatment arm having a complete tumor resection (R0), which indicates a microscopically margin-negative resection in which no gross or microscopic tumor remains in the tumor bed. The NACT-only treatment arm had an R0 resection rate of 50%. Patients in the Company's completed Phase 1b dose-escalation OVATION I Study showed compelling objective response rates, with 100% of patients in high-dose cohorts experiencing a complete or partial response, and 67% of patients in lower-dose cohorts experiencing a complete or partial response. Further, R0 resections in the high-dose cohorts was 88%, compared with 33% in the low-dose cohorts. In addition, Celsion compared matched patient data in a synthetic control arm with results from the OVATION I Study. Patients in the GEN-1 arm virtually demonstrated a doubling of control of their cancer compared with the synthetic control arm. Findings are not statistically significant due to the small number of patients.