Test Predicts Risks in Human Drug Trials

An assay based on an immunohistochemistry (IHC) technique has been developed to predict problems before a new drug is tested in live human volunteers.

A team of five scientists from Asterand (Detroit, MI, USA) laboratories developed the assay, which the company can perform on human tissue samples. It is possible that the test might have been helpful in screening the drug candidate that recently caused severe reactions in a group of six young men in a clinical trial carried out at Northwick Park in London, UK.

The IHC technique tests human or humanized antibodies being considered as drug candidates for possible side effects. The unmodified antibody under consideration is used to stain a range of human tissues, some containing the target protein or tumor, as well as normal tissues representing different parts of the body. Whether the target protein is expressed in diseased and/or normal tissue is then easily determined.

"These antibodies theoretically bind to a very specific target,” stated Dr. Alexey Glazyrin, one of the leaders of the Asterand team. "However, no one can guarantee that the antibody does not also bind to other cells in the human body. If this happens, a type 2 allergic reaction can be triggered with the immunity system launching a massive attack against cells attached to antibodies, as possibly happened in the recent British trial.”

Randal Charlton, CEO of Asterand, believes that before the end of the decade, regulators will insist that trials using human tissue will be carried out before drugs enter clinical trials involving human volunteers.



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