20 June 2018 - - Irving, California-based global biotechnology company Aivita Biomedical has randomized its first patient in the Phase II clinical trial for newly diagnosed advanced ovarian cancer, the company said.
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.