Celsion Announces Positive Data from the OVATION Study - An Immunotherapy Study of Newly Diagnosed Ovarian Cancer Patients
"The totality of study data available to date suggests that GEN-1 holds great potential to serve as an effective, safe IL-12 immunotherapy in ovarian cancer," said Dr.
The OVATION Study is designed to enroll three to six patients per dose cohort, and will continue into 2016 at higher doses of GEN-1 with the goal to
identify a safe, tolerable and therapeutically active dose of GEN-1 by recruiting and maximizing an immune response. The first two cohorts each enrolled three patients. Enrollment in the third cohort is ongoing, and
OVATION Study - Results to Date
- Of the first six patients dosed, one patient demonstrated a complete response (CR), two patients demonstrated partial response (PR) and three patients demonstrated stable disease (SD), as measured by RECIST criteria.
- Five patients had successful resections of their tumors, with two patients having an R0 resection, which indicates a
microscopically margin-negative resection in which no gross or microscopic tumor remains in the tumor bed and three patients with a R1 resection, indicating microscopic residual tumor. One patient in the second cohort is currently ineligible for debulking surgery due to a medical complication unrelated to the study or the study drug.
- Of the five surgically treated and evaluable patients, one patient demonstrated a pathological complete response (pCR), two patients (40%) demonstrated a micro pathological response (microPR), and two patients (40%) demonstrated a macroPR. These data compare favorably to historical data, which indicate that pCRs are typically seen in less than 7% of patients receiving neoadjuvant chemotherapy followed by surgical resection. pCRs 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 pCR. In addition, microPRs are seen in approximately 30% of patients, and are associated with a median overall survival of 38 months¹.
"GEN-1 continues to demonstrate impressive activity in patients with advanced Stage III and IV ovarian cancer, a population clearly in need of effective therapies," 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 email@example.com
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