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Case Study 1

Northwick Park

If the Alcyomics SkimuneĀ® technology had been available the Northwick Park drug trial disaster, which resulted in catastrophic systemic organ failure in human subjects, could have been averted. Most of us remember vividly the drug trial conducted at the Northwick Park Hospital in London. This was an extreme example of what can go wrong when drugs are introduced to patients without the correct testing protocols.

The anti TNF (tumour necrosis factor) receptor antibody (which gave rise to a lethal cytokine storm) had been tested vigorously in pre-clinical trials in macaque monkeys. However the testing in monkeys was inappropriate due to the type of receptor antibody used. This is one extreme example of how testing in species other than man can have devastating consequences. This extreme example demonstrates the need for more effective drug testing and human in vitro models. This is especially true when one considers the increasing number of biological drugs (e.g. monoclonal antibodies, biosimilars and cellular therapies) planned or in development.

The antibody is of course no longer on the market but Alcyomics has signed a Material Transfer Agreement with NIBSC (The National Institute for Biological Standards and Control) and is testing their analogue of the antibody, raised for in vitro testing, in order to alleviate this type of problem in the future. Alcyomics is now working with NIBSC as a partner supported by a TSB grant in the development of a prototype to further develop the assays in this regard.

Alcyomics has tested the anti-TNF antibody in the human in vitro skin explant assay SkimuneĀ®Mab. The result shows a grade III reaction with sub-epidermal damage in the skin (skin blistering). The data shows that the assay could have predicted and prevented the Northwick Park disaster.