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Genaissance research could predict drug side effect risk

Genaissance Pharmaceuticals has discovered genetic markers that the company believes can predict who is at risk of developing clozapine-induced agranulocytosis, a life-threatening decrease of white blood cells that is a fatal side effect of clozapine-based schizophrenia drugs such as Novartis' Clozaril.

Genaissance said the findings may apply to other drugs that also affect white blood cell counts.

“In light of recent drug withdrawals and labeling restrictions due to rare but serious adverse drug events, these results underscore the potential of pharmacogenetics to identify individuals who are at particular risk for developing fatal adverse drug reactions,” said Kevin Rakin, president and CEO of Genaissance.

“Clozapine has long been accepted as one of the most effective medications for treating schizophrenia but has had limited utilization due to the risk of inducing agranulocytosis,” said Dr John Kane, chairman of the department of psychiatry at the Zucker Hillside Hospital, Professor of Psychiatry at Albert Einstein College of Medicine, and co-chair of the study’s steering committee.

“These findings have moved us one step closer to realizing an alternative approach in the prescribing of clozapine where a one-time genetic test may someday alleviate the need for continuous blood monitoring for the majority of clozapine treated patients,” Dr Kane concluded.

Genaissance believes that these scientific findings have uncovered new clues to the underlying biological and physiologic mechanisms of drug-induced agranulocytosis and provide a starting point for elucidating a common mechanism across drugs from different classes that carry this rare but devastating side effect.

Genaissance is preparing a patent application designed to protect its novel findings and will provide further details after its anticipated filing of this application with the US Patent and Trademark Office.