Navigation Links
Duke and the Internationalserious 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

Related biology news :

1. Faster koa tree growth without adverse ecosystem effects
2. Herceptin and chemo improves response rates without major adverse effects in HER2 breast cancer
3. Medicines derived from cannabis: a review of adverse events
4. International Serious Adverse Events Consortium announces initial study results in its global research collaboration to identify genetic markers related to drug induced liver injury
5. Complications early in pregnancy or in previous pregnancies adversely affect existing or subsequent pregnancies
6. Controlling for size may also prevent cancer
7. Avocados may help prevent oral cancer, OSU study shows
8. Dietary calcium could possibly prevent the spread of breast cancer to bone
9. Bilberry extract -- can it help prevent certain cancers?
10. Preventing tuberculosis reactivation
11. NIH hosts event to launch Council of Science Editors global theme issue
Post Your Comments:
(Date:10/29/2015)... 2015  Rubicon Genomics, Inc., today announced an ... its DNA library preparation products, including the ThruPLEX ... Plasma-seq kit. ThruPLEX Plasma-seq has been optimized for ... libraries for liquid biopsies--the analysis of cell-free circulating ... in cancer and other conditions. Eurofins Scientific is ...
(Date:10/27/2015)... YORK , Oct. 27, 2015 In ... major issues of concern for various industry verticals such ... is due to the growing demand for secure & ... in various ,sectors, such as hacking of bank accounts, ... for electronic equipment such as PC,s, laptops, and smartphones ...
(Date:10/26/2015)... LAS VEGAS , Oct. 26, 2015 /PRNewswire/ ... innovator in modern authentication and a founding member of ... of its latest version of the Nok Nok™ S3 ... use standards-based authentication that supports existing and emerging methods ... is ideal for organizations deploying customer-facing applications that require ...
Breaking Biology News(10 mins):
(Date:12/1/2015)... SAN FRANCISCO , Dec. 1, 2015  Twist Bioscience, ... CEO, Emily Leproust , Ph.D., has been selected as ... of 2015 for fast-tracking the building blocks of life ... Global Thinkers whose contributions and work have changed ... --> "It is an honor to be ...
(Date:12/1/2015)... ALEXANDRIA, Va. , Dec. 1, 2015 ... provides senior debt to life sciences and healthcare services ... senior secured term loan with MDRejuvena, Inc. ("the Company"). ... commercialization and continued development of the Company,s Rejuvaphyl™ and ... --> Rejuvaphyl is the MDRejuvena brand of high ...
(Date:12/1/2015)... Dec. 01, 2015 ... of the "2016 Europe Cell Surface ... Technologies, Competitive Strategies, Opportunities for Suppliers--France, Germany, ... offering. --> ) has ... Europe Cell Surface Markers: Country Volume and ...
(Date:12/1/2015)... ... December 01, 2015 , ... Park Systems , ... add-on scanning ion conductance microscopy module to Park NX10 that is the only ... Park SICM benefits virtually all materials characterization that require measurements in liquid such ...
Breaking Biology Technology: