Celsion Announces Presentation of OVATION Study Findings at the Upcoming AACR Special Conference
The Company announced that an abstract for the OVATION Study has been accepted for presentation at the
- The abstract, entitled "Immunological changes following intraperitoneal administration of a formulated IL-12 plasmid in combination with neoadjuvant chemotherapy in newly diagnosed advanced ovarian cancer patients," will be presented in a poster presentation session by Dr.
Khursheed Anwer, Celsion's executive vice president and chief scientific officer.
- The presentation will summarize clinical findings and translational data from all patients treated in the Phase Ib dose escalating clinical trial. The translational data provides further insight into GEN-1's mechanism of action through the evaluation of dose-related changes in the tumor and peritoneal immune cell population, as well as through the peritoneal cytokine levels.
- Of the fourteen patients treated to date in
the entire study, two (2) patients demonstrated a complete response, ten (10) patients demonstrated a partial response and two (2) patients demonstrated stable disease, as measured by RECIST criteria. This translates to a 100% disease control rate ("DCR") and an 86% objective response rate ("ORR"). Of the five patients treated in the highest dose cohort, there was a 100% objective response rate with one (1) complete response and four (4) partial responses.
- Fourteen patients had successful resections of their tumors, with nine (9) patients (64%) having an R0 resection, which indicates a microscopically margin-negative resection in which no gross or microscopic tumor remains in the tumor bed. Seven out of eight (87%) patients in the highest two dose cohorts experienced a R0 surgical resection. All five patients treated at the highest dose cohort experienced a R0
- All patients experienced a clinically significant decrease in their CA-125 protein levels as of their most recent study visit. CA-125 is used to monitor certain cancers during and after treatment. CA-125 is present in greater concentrations in ovarian cancer cells than in other cells.
- Of the eight patients who have received GEN-1 treatment over one year ago and are being followed, only two patients' cancer has progressed. This compares favorably to the historical median progression free survival (PFS) of 12 months for newly-diagnosed patients with Stage III and IV ovarian cancer that undergo neoadjuvant chemotherapy followed by interval debulking surgery. Of the remaining six patients who have been on the study for over one year, their average PFS as of this date is 17 months with the longest progression-free patient at 23 months.
"We have completed enrollment of our OVATION Study in newly diagnosed ovarian cancer patients, one goal of which is to determine GEN-1's activity in combination with standard chemotherapy. The remarkable surgical outcomes among all patients completing the prescribed eight weekly treatments reinforce our confidence in the promise of GEN-1's ability to work safely and effectively in advanced ovarian cancer," said
OVATION Study Design
The Phase Ib trial will evaluate weekly intraperitoneal dosing of GEN-1 in combination with neoadjuvant chemotherapy, the standard of care for patients newly diagnosed with ovarian cancer. Concurrently with neoadjuvant chemotherapy, enrolled patients will receive escalating weekly doses of GEN-1, from levels beginning at 36mg/m², to 47mg/m², 61mg/m² and 79mg/m² weekly for 8 treatments in total, with interval debulking surgery to follow. The regimen will primarily be evaluated for its safety and tolerability.
About GEN-1 Immunotherapy
GEN-1, designed using
Celsion Investor Contact
Jeffrey W. ChurchSr. Vice President and CFO 609-482-2455 email@example.com
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