Edmonton-based Isotechnika Inc. said results from the rat carcinogenicity study for its lead immunosuppressive drug, ISA247. ISA247 did not exhibit any carcinogenicity up to the highest doses tested in male and female rats over a two year period.
Carcinogenicity studies are required by the United States Food and Drug
Administration (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.
Edmonton-based Isotechnika Inc. is an international biopharmaceutical company focused on the discovery and development of novel immunosuppressive therapeutics that are designed to offer advantages over other currently available treatments. It is estimated that the market potential exceeds $2 billion annually in sales for calcineurin inhibitors such as ISA247. ISA247 is currently being investigated in a phase IIb North American trial for the prevention of kidney graft rejection subsequent to transplantation and phase III European/Canadian psoriasis trial.