Provenge: which tox species, and why?

“The immunogenicity and anti-tumour properties of these surrogate products were evaluated in rats and mice.”

“Animal models using species-specific variations of the human cell therapy product have been used.”

“The equivalent of sipuleucel-T has been prepared from rat APCs loaded with PAP•GM-CSF fusion proteins”

“The general battery of non-clinical toxicology studies were not submitted by the applicant.”

“Conventional reproductive and development toxicity studies were not considered relevant given the nature and the intended clinical use of this autologous cell therapy product.”

“The absence of genotoxicity, mutagenicity and carcinogenicity studies was considered acceptable taking into account the nature of sipuleucel-T.”

“The equivalent of sipuleucel-T has been prepared from rat APCs loaded with PAP•GM-CSF fusion proteins composed of rat or human PAP (rPAP and hPAP, respectively) fused to the rat or murine GM-CSF homologues (rPAP•rGM–CSF and hPAP•mGM-CSF, respectively).”