Celsion Corporation Announces DSMB has Confirmed Initial Safety of Weekly GEN-1 Dosing at 100 mg/m² in 15 Randomized Patients with Advanced Ovarian Cancer
Phase 2 Portion Will Continue After Patients Have Completed Their Full Treatment Regimen of up to 17 doses of GEN-1 plus Standard Chemotherapy
The OVATION 2 Study is an open label, 130 patient, 1 to 1 randomized Phase II trial, 80% powered to show the equivalent of a 33% improvement in progression-free survival (PFS), the primary endpoint, when comparing the treatment arm (NACT + GEN-1) with the control arm (NACT alone). GEN-1, is a formulation of
The OVATION 2 Study builds on promising clinical and translational research data from the Phase IB OVATION I Study, in which enrolled patients received escalating weekly doses of GEN-1 (from 36 mg/m² to 79 mg/m²) for a total of eight treatments in combination with NACT, followed by IDS. These data from the OVATION I Study were presented at the ASCO-SITC Clinical-Oncology Symposium by Dr.
"This latest DSMB review of GEN-1 at 100 mg/m² confirmed that there were no dose limiting toxicities detected in any of the six evaluable patients (those patients who received at least four doses of GEN-1) and that intraperitoneal GEN-1 administration is well tolerated even when given with standard NACT," said
Dr. Borys concluded, “We anticipate that the Phase II portion of the OVATION 2 Study will begin enrolling patients at more than 25 clinical sites in the U.S. and
The OVATION 2 Study is supported with promising clinical and translational data from the Company’s prior Phase Ib OVATION I Study. In addition to a 100% objective response rate (complete response + partial response) observed in all 9 patients at the two highest dose cohorts, translational research data demonstrates that GEN-1 is biologically active, producing therapeutic levels of IL-12 cytokines and positively impacting T-cell population in the tumor.
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