Celsion to Initiate Phase 1/2 Trial of GEN-1 in Newly-diagnosed Ovarian Cancer Patients

Celsion to Initiate Phase 1/2 Trial of GEN-1 in Newly-diagnosed Ovarian Cancer Patients
A Phase 1/2 trial to evaluate the DNA-based immunotherapy GEN-1 in patients with newly-diagnosed advanced ovarian cancer has been cleared by the U.S. Food and Drug Administration (FDA) without restrictions, Celsion announced. Recruitment for Phase 1 of the trial, called OVATION II (NCT03393884), is expected to begin by July this year and reach 25 percent of the enrollment goal of 90 patients by the end of 2018. The study will be conducted at up to 15 U.S. centers. “GEN-1 holds the potential for tremendous promise as a cancer treatment in the rapidly emerging area of immunotherapy," Michael H. Tardugno, Celsion’s chairman, president and chief executive officer, said in press release. "This new trial will evaluate GEN-1’s value as an adjuvant to current standard of care in newly diagnosed Stage III/IV ovarian cancer patients with a relatively healthy immune system." GEN-1 is a nanoparticle containing the DNA sequence for the pro-inflammatory protein interleukin-12 (IL-12). When delivered to a tumor site, GEN-1 induces a sustained production and release of IL-12, leading to an active immune response that kills tumor cells. OVATION II is designed to evaluate the safety and effectiveness of GEN-1, and to shed light on its biological activity, in patients newly diagnosed with stage 3 or 4
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