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Case Study 3

Pharmaceutical Industry

Skimune®Pharm is designed to predict first-in-man hypersensitivity or adverse immune reactions in response to small or large molecule therapeutics.

Our client, a global pharmaceutical company requested Alcyomics to determine in vitro responses to a number of small molecule drugs known to be associated or not associated with adverse immune reactions upon administration to humans. The study, involving the use of Skimune®Pharm, was performed blind. Results showed a positive response to nevirapine, lamotrigine, carbamazepine (grade II response – data not shown ) and phenobarbital (grade III response) and a negative response to metformin and sulphamethoxazole (see Figure1). A 0.86 correlation coefficient between Skimune®Pharm results and clinical outcome was determined. The high correlation to clinical outcome indicates the strong predictive capacity of the Skimune®Pharm assay and how it can be used as a pre-clinical tool to determine adverse effects of therapeutic drugs.

Figure 1  Histopathological analysis of the adverse effects  of small molecule drugs. Skin incubated with phenobarbital showing a grade III positive response, metformin and sulphamethoxazole showing a grade I negative response. In the positive biopsy (A) arrows point to vacuolisation of keratinocytes and cleft formation.

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