Celsion Announces Continuing Positive Data from the OVATION Study in Newly Diagnosed Advanced Ovarian Cancer Patients
Fourth Cohort of Patients Continues to Show Clinically Meaningful Responses in the Evaluation of GEN-1, A Novel IL-12 DNA-based Immunotherapy, in Combination with the Standard of Care
"These early results have
impressed our investigators which accounts for the rapid patient accrual in the study. The consistency and robust nature of the data across all four cohorts and the encouraging clinical responses underscore the potential of GEN-1 to serve as an effective, safe IL-12 immunotherapy in ovarian cancer," said
The OVATION Study is designed to enroll three to six patients per dose cohort with the goal of identifying a safe, tolerable and immunologically active dose of GEN-1 by recruiting and maximizing an immune response. The first four cohorts have each enrolled three patients. Enrollment in the fourth cohort is ongoing with the goal of enrolling three additional patients in this final dose cohort.
OVATION Study - Totality of Results in the First Four Patient Cohorts
- Of the first twelve patients dosed, one patient demonstrated a complete response (CR), eight patients demonstrated a partial response (PR) and three patients demonstrated stable disease (SD), as measured by RECIST criteria. This translates to a 100% disease control rate (DCR), and 75% objective response rate (ORR). These results compare very favorably to the current standard of care.
- Eleven patients had successful resections of their tumors, with six patients having an optimal R0 resection, which indicates a microscopically margin-negative resection in which no gross or microscopic tumor remains in the tumor bed, and four patients with a R1 resection, indicating microscopic residual tumor. One patient had an R2, indicating macroscopic residual tumor. One patient in the second cohort was ineligible for debulking surgery due to a medical complication unrelated to
the study or the study drug.
- Of the eleven surgically treated and evaluable patients, one patient demonstrated a complete pathological response (cPR), five patients demonstrated a micro pathological response (microPR), and five patients demonstrated a macroPR. These data compare favorably to historical data, which indicate that cPRs are typically seen in less than 7% of patients receiving neoadjuvant chemotherapy followed by surgical resection. cPRs have been associated with a median overall survival of 72 months, which is more than three years longer than those who do not experience a cPR. In addition, microPRs are seen in approximately 30% of patients, and are associated with a median overall survival of 38 months¹.
- All eleven patients who completed treatment follow-up experienced a dramatic (greater than 90%) drop 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. A 50% reduction in CA-125 levels is considered meaningful.
OVATION Study - Top Line Translational Data from First Two Cohorts
"These results build on the impressive clinical findings we observed in our earlier GOG Study as well as the translational data from
this same study. As we move closer towards the final design of a Phase I/II trial to evaluate the synergistic anti-cancer effects of GEN-1 together with Avastin® and Doxil®, these results also provide strong clinical evidence for the potential of GEN-1 in ovarian cancer," said
About Celsion Corporation
¹ Petrillo M, Zannoni GF, Tortorella L, et al. Prognostic role and predictors of complete pathologic response to neoadjuvant chemotherapy in primary unresectable ovarian cancer.
Celsion Investor ContactSource:
Jeffrey W. ChurchSr. Vice President and CFO 609-482-2455 firstname.lastname@example.org
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