FDA provides clearance for Celsion’s OVATION II study for treatment of stage 3/4 ovarian cancer

The Food and Drug Administration (FDA) provides clearance for the OVATION II study, phase I/II clinical trial of GEN-1, Celsion’s DNA-based immunotherapy for the localized treatment of ovarian cancer. This phase I/II study is designed with a single-dose escalation phase to 100 mg/m² to identify a safe and tolerable dose of GEN-1 while maximizing an immune response, followed by a continuation at the selected dose in phase II in an open label, 1:1 randomized design of up to 90 patients with stage 3/4 ovarian cancer at up to 15 US centers. The enrollment of the phase I portion of the OVATION II study is expected in the first half of 2018.

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