ISA247 is currently being investigated in a phase IIb North American trial for the prevention of kidney graft rejection subsequent to transplantation and a phase III European/Canadian psoriasis trial.
Carcinogenicity studies are required by the FDA and other regulatory authorities and are a critical part of the package submitted for marketing approval. Carcinogenicity studies are performed by administering a range of doses of a drug, including a dose considerably higher than the anticipated clinical dose for a period of two years. This timeframe is equivalent to administering the drug over a lifetime in humans.