Laviv: which tox species, and why?

“No preclinical studies were conducted with this product.”

“The BLA states that due to this previous commercial experience in humans, and due to the lack of a”

“The preparation of the rabbit analog cells used in this study did not duplicate the procedure that is used for IT preparation”

“Toxicology studies as described in the International Conference on Harmonisation (ICH) Safety (‘S’) guidelines, consisting of pharmacokinetics, acute toxicology, chronic toxicology, genotoxicity, carcinogenicity, reproductive and developmental toxicity, safety pharmacology, and immunotoxicity (http://www.ich.org/cache/compo/276-254- 1.html) were not conducted by the sponsor due to the autologous nature of IT and the previous human experience.”

“Toxicology studies as described in the International Conference on Harmonisation (ICH) Safety (‘S’) guidelines, consisting of pharmacokinetics, acute toxicology, chronic toxicology, genotoxicity, carcinogenicity, reproductive and developmental toxicity, safety pharmacology, and immunotoxicity (http://www.ich.org/cache/compo/276-254- 1.html) were not conducted by the sponsor due to the autologous nature of IT and the previous human experience.”

“Toxicology studies as described in the International Conference on Harmonisation (ICH) Safety (‘S’) guidelines, consisting of pharmacokinetics, acute toxicology, chronic toxicology, genotoxicity, carcinogenicity, reproductive and developmental toxicity, safety pharmacology, and immunotoxicity (http://www.ich.org/cache/compo/276-254- 1.html) were not conducted by the sponsor due to the autologous nature of IT and the previous human experience.”

“No preclinical studies were conducted by the sponsor with the clinical product, Isolagen Therapy™, or with an animal cellular analog in support of early phase to later phase clinical trials.”