Monday, June 05, 2017 9:16:57 AM
“The OVATION study has accrued patients from four major research cancer centers. We have seen highly promising clinical findings including a patient with a complete pathological response along with a very high rate of R0 at time of debulking surgery. The translational research data in the poster presentation demonstrates that GEN-1 is producing beneficial cytokines and positively impacting T-cells in the tumor,” said Dr. Premal Thaker. “This is strong early data and we believe that GEN-1 may be stimulating the immune system to improve tumor control in these patients. I am looking forward to continuing our clinical evaluation of GEN-1 in subsequent ovarian cancer studies.”
Celsion reported encouraging clinical data from the first fourteen patients who have completed treatment in the OVATION Study. GEN-1 plus standard chemotherapy produced positive results, with no dose limiting toxicities and promising dose dependent efficacy signals which appear to correlate well with successful surgical outcomes as summarized below:
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. Of the five patients treated at the highest dose cohort, all five patients (100%) experienced a R0 surgical resection.
One patient demonstrated a pathological complete response (pCR). pCRs are typically seen in less than 7% of patients receiving neoadjuvant chemotherapy followed by surgical resection, and have been associated with a median overall survival (OS) of 72 months, which is more than three years longer than those who do not experience a pCR.
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.
Celsion also reported supportive translational research data from the first four patient cohorts who have completed treatment in the OVATION Study. 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.
100% Disease Control Rate! Wow!
GO $CLSN
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