Korjuny: which tox species, and why?

“None of the animal species analysed is suitable for assessing the safety of catumaxomab.”

“None of the studies demonstrated binding of catumaxomab to cells from non-clinical species.”

“Since BiLu recognises only murine CD3 but not murine EpCAM, the surrogate mAb only partially reflects the functionality of catumaxomab.”

“Therefore, a limited toxicology programme was performed, i.e. single dose toxicity studies with catumaxomab in mice, rats and cynomolgus.”

“Studies to investigate reproductive and developmental toxicity have not been performed due to the lack of an appropriate animal species, the intended patient population with late-stage malignant disease.”

“Standard carcinogenicity studies are generally inappropriate for biotechnology-derived pharmaceuticals according to ICH S6.”

“In addition, a single escalating dose study was performed with the surrogate mAb BiLu in mice.”