Aivita Launches Phase 2 Trial of Dendritic Cell Immunotherapy for Ovarian Cancer

Aivita Launches Phase 2 Trial of Dendritic Cell Immunotherapy for Ovarian Cancer
Aivita Biomedical has initiated a Phase 2 trial of a new kind of dendritic cell immunotherapy for certain types of ovarian cancer. The therapy uses a patient’s own dendritic cells, which are boosted to fight the tumor by exposure to tumor proteins. The trial is running at the Hoag Memorial Hospital Presbyterian in Newport Beach, California. The company plans to add additional sites in the coming year. The study, called Root of Cancer (NCT02033616), will enroll 99 women who will be randomly assigned treatment with the immunotherapy — called AVOVA-1 — or a monocyte placebo control. Monocytes are a cell type similar to dendritic cells. For every two patients receiving the active treatment, one will get a placebo. Women with stage 3 or 4 epithelial ovarian, fallopian tube, or primary peritoneal carcinoma will be included in the study. To be eligible for participation, women need to have had debulking surgery to remove the larger part of the tumor. They also need to be in relatively good general condition. Researchers will assess patients’ overall survival in a five-year frame — a measure making up the study’s primary objective. But they will also assess progression-free survival, measuring how quickly patients progress after the treatment. Meanwhile, Aivita is working to identify a marker that can be used to evaluate the effectiveness of the dendritic cell treatment. The company is also developing an assay to predict the potency of the therapy. The treatment is produced by isolating immune cells from the blood. The
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