Patients eligible for randomization and treatment meet the following criteria: those who have undergone debulking surgery, for whom a cell line has been established, who have undergone leukapheresis from which sufficient monocytes were obtained, and have an ECOG performance grade of 0 or 1.
The ovarian Phase II double-blind study will enroll approximately 99 patients who will be randomized in a 2:1 ratio to receive either autologous dendritic cell vaccine or autologous monocytes as a comparator.
Aivita has received seven patient tumor specimens from a single clinical site, and has successfully generated a treatment for each patient, yielding a 100% manufacturing success rate and prompting expansion to multiple centers.
Aivita's ROOT OF CANCER treatment is a platform technology applicable to most solid tumor types and consists of autologous dendritic cells loaded with autologous tumor antigens from autologous self-renewing tumor-initiating cells.
Privately held Aivita Biomedical utilizes its expertise in stem cell growth and directed, high-purity differentiation to enable safe, efficient and economical manufacturing systems which support its commercial line of skin care products and therapeutic pipeline.
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