Celsion Updates Clinical Data from the OVATION Study in Newly Diagnosed Advanced Ovarian Cancer Patients
"This new data on progression-free survival adds to the impressive clinical findings seen across a number of meaningful measures used to assess ovarian cancer like a 75% objective tumor response rate and a greater than 50% R0 (margin-negative) surgical resection rate," said Dr.
The Company also reported preliminary translational research findings from the first four patient cohorts. The analysis of peritoneal fluid and blood samples collected immediately before and 24 hours after IP administration of multiple doses of GEN-1 (36, 47, 61, 72 mg/m2) and standard NACT (carboplatin every 21 days and Taxol weekly) shows clear evidence of IL-12 gene transfer by significant dose dependent increases in IL-12 levels and immune system activity and significant increases in IFN-gamma and decreases in VEGF levels. The treatment-related changes in immune activating cytokines and pro-tumor VEGF levels followed a dose-dependent trend and were predominantly in the peritoneal fluid compartment with little to no changes observed in the patients' systemic blood stream.
The immuno-histochemical (IHC) analysis of tumor tissue collected before treatment (laparoscopy) and after completion of eight GEN-1 weekly treatments showed increased infiltration of CD3+, CD4+ CD8+ T-cells into tumor tissue of several patients. The most pronounced effects observed in the IHC analysis were decreases in the density of immunosuppressive T-cell signals (FoxP3, PD-1, PDL-1, IDO-1) in the tumor microenvironment. The ratio of CD8+ cells to immunosuppressive cells was increased in 60-80% of patients suggesting an overall shift in the immune environment to pro-immune stimulatory following treatment with GEN-1.
"These translational research findings demonstrate that GEN-1 in ovarian cancer patients is biologically active and creates an immuno-stimulatory cytokine milieu in the peritoneal cavity in a dose-dependent manner and promotes a pro-immune T-cell population dynamics in the tumor micro-environment," said Dr.
About Celsion Corporation
Celsion Investor ContactSource:
Jeffrey W. ChurchSr. Vice President and CFO 609-482-2455 email@example.com
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