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Duke and the International Serious Adverse Event Consortium to partner on research

Chicago (January 27, 2009) The International Serious Adverse Events Consortium (SAEC) announced today it will collaborate with Duke University's Center for Human Genome Variation ( ) to research the genetics of Clozapine-induced agranulocytosis (CIA), with the goal of identifying potential rare genetic variants predictive of this serious drug induced adverse event. The SAEC is a novel, non-profit international research consortium, formed by the global pharmaceutical industry, to better understand the role of genetics in drug safety. Duke University's Center for Human Genome Variation, under the leadership of David Goldstein, PhD and Professor of Molecular Genetics & Microbiology, applies state-of-the-art genomic science to help understand how human genetic variation influences disease and drug response. Dr. Anna Need, of Duke's Department of Psychiatry will jointly manage the collaborative research.

Clozapine is an atypical antipsychotic agent used extensively in the treatment of schizophrenia patients. An important factor limiting its use is the risk of potentially fatal agranulocytosis, estimated in less than 2 percent of treated patients. Agranulocytosis is the failure of the bone marrow to produce enough white blood cells (neutrophils) resulting in a significantly reduced immune response. Clozapine is made available through a special FDA sanctioned special surveillance system (Clozapine Patient Management System). Under this program, patients must have a weekly white-cell count to receive their supply of the drug.

Last fall, the SAEC received as a gift, the research materials and data relating to the CIA cohort to be used in the collaboration from PGx Health (, a division of Clinical Data, Inc. These data corroborated the already published evidence for genetic associations in HLA region (Chromosome 6) consistent with a proposed immunological mechanism as an important causal factor associated with CIA. The Duke-SAEC plans to expand on these data by conducted more extensive studies of CIA using state-of-the-art whole genome sequencing techniques.

"Our genetic research on both drug-induced liver injury and serious skin rashes points to a strong role of the immune system in contributing to these adverse responses." said Arthur L. Holden, Chairman of the SAEC. "By researching the genetics of drug induced CIA, we hope to further our understanding into the genetics of immunologically mediated adverse drug responses. Our collaboration with Duke University's Center for Human Genome Variation represents our first pilot to use whole genome sequencing technology to better understand the role of rare genetic variation in such events."

"For many patients Clozapine is the most effective drug available, but its use is constrained by the possibility of this serious adverse event requiring intrusive monitoring programs." said David Goldstein, PhD, Professor of Molecular Genetics & Microbiology at Duke University. "We hope that understanding the genetics of CIA will not only reduce its occurrence, but also allow wider use of Clozapine."


Contact: Arthur L. Holden
Zeno Group

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