Poster on Celsion Corporation’s Phase I/II OVATION 2 Study to be Presented at the Society of Gynecologic Oncology Virtual Annual Meeting on Women’s Cancer
The conference is being held
“We are delighted that the
The poster describes the OVATION 2 Study, which combines GEN-1 with standard-of-care neoadjuvant chemotherapy (NACT) 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 (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).
The poster will be available https://investor.celsion.com/scientific-presentations on
The Company recently announced that to date it has enrolled approximately one-third, or 34 patients, of the anticipated 110 patients to be enrolled into the OVATION 2 Study, of which 20 are in the treatment arm and 14 are in the control. Currently, 28 patients have had their interval debulking surgery with the following results:
- 13 of 16, or 81%, of patients treated with GEN-1 had a R0 resection, which indicates a microscopically margin-negative complete resection in which no gross or microscopic tumor remains in the tumor bed.
- 7 of 12 patients, or 58%, of patients in the control arm had an R0 resection.
- This interim data represents a 40% improvement in R0 resection rates for GEN-1- patients compared with control arm patients and is consistent with the reported improvement in resection scores noted in the encouraging Phase I OVATION 1 Study, the manuscript of which has been submitted for peer review publication.
About GEN-1 Immunotherapy
GEN-1, designed using
About the Virtual Annual Meeting on Women’s Cancer
About Celsion Corporation
Forward-looking statements in this news release are made pursuant to the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. These statements are subject to a number of risks and uncertainties, many of which are difficult to predict, including, unforeseen changes in the course of research and development activities and in clinical trials; the uncertainties of and difficulties in analyzing interim clinical data, particularly in small subgroups that are not statistically significant; FDA and regulatory uncertainties and risks; the significant expense, time and risk of failure of conducting clinical trials; the need for
Celsion Investor Contact
Executive Vice President and CFO
LHA Investor Relations
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Source: Celsion CORP