- Celsion Corporation (NASDAQ:CLSN) provides an update on its Phase Ib dose escalating clinical trial (the OVATION Study) combining GEN-1 with neoadjuvant chemotherapy for the treatment of patients with Stage III and IV ovarian cancer followed by interval debulking surgery.
- Enrollment got complete in the OVATION study. The clinical findings from the study enrolling 14 patients are as follows:
- 86% Objective Response Rate (ORR) in Phase IB dose escalating study.
- 100% ORR and 100% R0 (Margin Negative) surgical resection rate at highest dose cohort.
- Final translational research data is being collected and will be available in Q3 for evaluation. Previous research findings from the first four patient cohorts are as below:
- The ratio of CD8+ cells to immunosuppressive cells was increased in ~75% of patients suggesting an overall shift in the immune environment to pro-immune stimulatory following treatment with GEN-1. This increase is believed to be a good predictor of better overall survival.
- Progression free survival update. Of the seven patients who have received GEN-1 treatment over one year ago, only one patient’s cancer has progressed after 11.7 months compared to progression free survival (PFS) of 12 months. Of the remaining six patients, their average PFS is 15 months with the longest progression-free patient at 21 months. None of the patients in the third or fourth dose cohorts have progressed to date.
- Shares are up 34% premarket on modest volume.
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