Provenge: animal efficacy model or human cells?

“ability of rat APCs loaded with rPAP•rGM-CSF fusion protein to stimulate prostate specific inflammation, and the ability of antigen loaded APCs to protect against tumour challenge in mice.”

“It was acknowledged that the use of appropriate (prostate) tumour models was difficult if not impossible since such models were not available at the time of performing the non-clinical studies.”

“Although the pharmacology studies presented some deficiencies, the pharmacological data were considered sufficient to establish a proof-of-concept for treatment of patients with Provenge in the proposed indication.”