Celsion Announces Presentation of OVATION Study Findings at the Upcoming ASCO 2017 Annual Meeting
The Company announced that an abstract for the OVATION Study has been accepted for presentation at the
- The abstract, entitled "Phase 1 study of the safety and activity of formulated IL-12 plasmid administered intraperitoneally in combination with neoadjuvant chemotherapy in patients with newly diagnosed advanced stage ovarian cancer," will be presented in a poster presentation session on
Saturday, June 3rdfrom 1:15 PM to 4:45 PMby Dr. Premal H. Thaker, Associate Professor, Obstetrics and Gynecology Division of Gynecologic Oncology, Washington Universityin St. Louis School of Medicine.
- The presentation will summarize clinical findings and translational data from all available patients treated in the trial. The translational data will provide 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.
- Of the twelve patients treated, one patient demonstrated a complete response, eight (8) patients demonstrated a partial response and three (3) patients demonstrated stable disease, as measured by RECIST criteria. This translates to a 100% disease control rate ("DCR") and a 75% objective response rate ("ORR").
- Eleven patients had successful resections of their tumors, with six (6) patients (55%) having an R0 resection, which indicates a microscopically margin-negative resection in which no gross or microscopic tumor remains in the tumor bed, and four (4) patients (36%) having a R1 resection, indicating microscopic residual tumor.
- 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 dramatic 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.
"We have now completed enrollment of our OVATION Study in newly diagnosed ovarian cancer patients, one goal of which is to determine GEN-1's activity in combination with standard chemotherapy. The previously reported remarkable, unexpected surgical outcomes among all patients completing the prescribed eight weekly treatments reinforce our confidence in the promise of GEN-1's ability to work safely and effectively in advanced ovarian
OVATION Study Design
The Phase Ib trial will evaluate weekly intraperitoneal dosing of GEN-1 in combination with neoadjuvant chemotherapy, the standard of care for patients newly diagnosed with ovarian cancer. Concurrently with neoadjuvant chemotherapy, enrolled patients will receive escalating weekly doses of GEN-1, from levels beginning at 36mg/m², to 47mg/m², 61mg/m² and 79mg/m² weekly for 8 treatments in total, with interval debulking surgery to follow. The regimen will primarily be evaluated for its safety and tolerability.
About GEN-1 Immunotherapy
GEN-1, designed using
Celsion Investor ContactSource:
Jeffrey W. ChurchSr. Vice President and CFO 609-482-2455 firstname.lastname@example.org
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