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news.Biopharmaceutical firm Isotechnika has confirmed that its lead immunosuppressive drug ISA247 did not exhibit any carcinogenicity up to the highest doses tested in male and female rats over a two-year period.
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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.