Celsion Corporation (NASDAQ: CLSN) announced on Tuesday its final clinical and translational research data from its OVATION Study at the American Association of Cancer Research Special Conference. The study was a Phase 1b dose clinical trial combining GEN-1, Celsion’s DNA immunotherapy, with the standard treatment for patients suffering from Stage 3 and 4 ovarian cancer.
The Phase 1b trial was to evaluate weekly intraperitoneal (membrane wall of abdominal) dosing of GEN-1 with the standard treatment, neoadjuvant chemotherapy, for ovarian cancer patients.
Celsion’s GEN-1 is an IL-12 DNA plasmid vector formulated as a nanoparticle in a non-viral delivery system to cause the sustained local production and secretion of the Interleukin-12 (IL-12) protein loco-regionally to the tumor site, according to its statement.
In the translational research, it showed that GEN-1 in patients created a shift in the tumor and the surrounding tumor area that promoted a pro-immune T-cell population dynamic and turning tumor naive T-cells into cytotoxic T-cells, or stimulating an immune response.
Celsion also reported very strong results in the clinical research among the fourteen patients in the study.
Of the fourteen patients in the study, two patients showed complete response, ten showed partial response, and two showed stable disease. This translate to a 100 percent disease control rate and an 86 percent objective response rate.
All patients also experienced a significant decrease in their CA-125 protein levels. CA-125 is used to monitor certain cancers during and after treatment. CA-125 is present in greater quantities in ovarian cancer cells than in other cells.
"We have completed enrollment of our Phase Ib OVATION Study in newly diagnosed ovarian cancer patients to determine GEN-1's clinical and biological activity in combination with standard chemotherapy. The remarkable surgical outcomes for all patients completing the prescribed eight weekly treatments of GEN-1 reinforce our belief in the promise of GEN-1's ability to work safely and effectively in advanced ovarian cancer," said Dr. Nicholas Borys, Celsion's senior vice president and chief medical officer.