- Celsion (NASDAQ:CLSN) provides an update on its Phase I/II OVATION 2 Study with GEN-1 in patients with advanced ovarian cancer, including interim observations.
- The company said it has now enrolled about one-third, or 34 patients, of the anticipated 110 patients to be enrolled into the study, of which 20 are in the treatment arm and 14 are in the control.
- 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 (PFS) (HR=0.75), the primary endpoint, when comparing the treatment arm (standard of care + GEN-1) with the control arm (standard of care alone).
- Celsion said that 22 clinical sites in the U.S. and Canada have been initiated for the trial, with three more sites expected to be added by the end of the first quarter.
- The FDA had granted Fast Track designation to Celsion's GEN-1 immunotherapy for advanced ovarian cancer, earlier this month.
- Shares of the company up nearly 9% premarket.