Laviv: what was done before first-in-human, and what came after?

“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.”

“No preclinical studies were conducted with this product.”

“No preclinical studies were conducted with this product.”

“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.”

“were not conducted by the sponsor due to the autologous nature of IT and the previous human experience.”

“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.”

“Regarding the in vivo assessment of tumorigenic potential: 1) only two animals were used and 2) the study duration was only 2 months, therefore no conclusions can be made about this safety endpoint.”

“The pharmacology/toxicology review of the original IND submission supported the sponsor’s decision, noting that these cells are autologous, minimally manipulated, highly unlikely to change in phenotype, dedifferentiate, migrate or become tumorigenic (see Attachment I).”