Celsion announces progression-free survival data from OVATION I study.
Celsion announced results from its dose escalating Phase IB OVATION I trial evaluating neoadjuvant chemotherapy, or NAC, treatment for six cycles and GEN-1 given weekly for a total of eight doses prior to interval debulking surgery in newly diagnosed patients with Stage III/IV ovarian cancer. Median progression-free survival, or PFS, in patients treated per protocol was 24.3 months and was 17.1 months for the intent-to-treat population for all dose cohorts, including three patients who dropped out of the study after 13 days or less, and two patients who did not receive full neoadjuvant chemotherapy and GEN-1 cycles. The results from the OVATION I Study support continued evaluation of GEN-1 based on promising tumor response, as reported in the PFS data, and the ability for surgeons to completely remove visible tumor at debulking surgery. In the OVATION I Study, complete tumor resections were achieved for all patients receiving the highest dose of GEN-1, and approximately 86% of patients in OVATION I had a complete or partial response. Patients administered GEN-1 and NAC demonstrated meaningfully longer PFS compared to the historical average for chemotherapy alone, with longer PFS observed in the higher dose cohorts. GEN-1 was well tolerated and no dose-limiting toxicities were detected. Intraperitoneal administration of GEN-1 was feasible with broad patient acceptance.
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|Date:||Oct 24, 2018|
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