The FDA greenlighted an application from California Stem Cell Inc. to begin Phase III studies of its cancer stem cell-based immunotherapy, DC-TC, in patients with metastatic melanoma.
About 250 patients with recurrent Stage III or Stage IV disease will be enrolled in the randomized, double-blind study to receive DC-TC injections for three consecutive weeks, and then once monthly for five months.
Enrollment will begin in the first quarter of 2014.
Robert Dillman, chief medical officer of California Stem Cell (CSC), told BioWorld Today that DC-TC is a cell product combining autologous dendritic cells and autologous tumor cells from the patient. The dendritic cell “literally eats the tumor cell,” Dillman said, and then presents protein material from that tumor cell to the immune system to activate both cellular and humoral immunity against those proteins.
The idea for DC-TC originally began with self-renewing