DCVAX-L was not used for Pl or Pll, of course. It was only introduced during the Plll.
“We tested the method with a single patient in 1997, and then moved to a phase 1 safety trial in the early 2000s,” says Dr. Liau, professor and chair of Neurosurgery at UCLA.
A series of phase 2 early efficacy and optimization trials followed, and then an international, multi-site study led by Dr. Liau began in 2007.
The vaccine consists of two components: a patient’s dendritic cells, which are special types of immune cells, and proteins prepared from a patient’s tumor.
To create the vaccine, which is individualized for each patient, medical staff first perform a procedure called leukapheresis, in which a patient’s blood is drawn and their white blood cells are collected. Then, the patient’s tumor is removed and sent to a lab where researchers obtain proteins from the specimen, called tumor lysate. The white blood cells are cultured to differentiate into dendritic cells, and then combined with the tumor lysate to make the vaccine.
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