Hamner Institutes-NC State Receive Challenge Grant To Study Drug-induced Liver Injury

From: MMI Public Relations
Published: Thu Dec 10 2009

The Hamner Institutes for Health Sciences has announced that Paul Watkins, M.D., founding director of The Hamner-UNC Institute for Drug Safety Sciences, and David W. Threadgill, Ph.D., Professor and Head of the Department of Genetics at North Carolina State University, have received a $1 million grant from the National Institute of Diabetes and Digestive and Kidney Disease to study why some patients can have serious liver reactions to otherwise safe drugs. The money is part of the Challenge Grant Program supported by federal stimulus dollars.

The two-year project will utilize the "Collaborative Cross," a unique mouse population that is being developed in North Carolina to model the genetic diversity of the human population and thereby improve the ability of rodent models to predict and understand human biology. It is anticipated that genetic risk factors will be uncovered that can then be tested in patients who have experienced liver injury due to drugs. This should lead to new clinical tests that can identify sensitive patients so that they can avoid drugs likely to cause a liver reaction. In addition, these studies should advance understanding that will permit the future design of safer medications.

"The major bottleneck in the development of new drugs is no longer demonstrating that they are effective, but rather the time and expense required establishing that they are safe," said Dr. Watkins. "The Collaborative Cross mice are a tremendous resource to help understand why some patients are more susceptible to adverse drug events than are others, and we are very excited to begin these studies."

"The Collaborative Cross is an unprecedented tool to study the complex interactions between genes and the environment that determine individual differences in susceptibility to common diseases," said Dr. Threadgill. "This resource can be used to investigate not only factors that determine susceptibility to adverse drug events, but also susceptibility to environmental toxicants or diseases such as colon or breast cancer."

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- Previous drug safety collaborative research between Drs. Watkins and Threadgill has indicated that there might be ways to predict cases of toxicity response in patients before they take certain drugs. The studies exploited genetic similarities between mice and humans to determine factors that predict patient risk of a toxicity response.

- Those early studies identified genes that contribute to liver toxicity due to acetaminophen, a drug that is known to cause liver injury at very high doses in both rodents and people.

- With the Collaborative Cross project, Drs. Watkins and Threadgill will seek to identify those genes that affect the toxicity of drugs that cause severe adverse reactions only in rare, susceptible patients. Most often, these drugs did not cause a toxicity reaction in normal rodents during pharmaceutical safety testing; only when thousands of patients are taking the drug do safety concerns emerge.

Paul Watkins, M.D., is the Verne S. Caviness distinguished professor of medicine, professor of toxicology, and professor of experimental therapeutics at The University of North Carolina at Chapel Hill (UNC). As an internationally recognized expert in drug safety, Dr. Watkins has extensive research experience in drug-induced liver injury (DILI), which includes basic investigation in drug metabolism and transport, clinical studies, causation assessment, and regulatory affairs. He has been continuously funded for over 20 years by the National Institutes of Health for basic and translational research, and he is one of the most frequently cited authors in the field of pharmacology.

Dr. David W. Threadgill was named Professor and Head of the Department of Genetics at North Carolina State University in 2008. Dr. Threadgill came to NC State from the University of North Carolina at Chapel Hill, where he was on the faculty in the Department of Genetics. His research focuses on understanding the genetics of individuality, particularly the identification and functional characterization of genes influencing a person's innate susceptibility to various diseases. The long-term goal of his work is predictive medicine, including more informed targeted screening for diseases and treatments to prevent diseases from becoming life-threatening. Dr. Threadgill’s research program has been funded over the last 15 years by the National Institutes of Health.

The Hamner Institutes for Health Sciences is a nonprofit research organization strategically located on a 56-acre campus in the heart of Research Triangle Park, North Carolina. For 35 years, scientists at The Hamner have conducted preeminent research in environmental health sciences and chemical risk assessment. Built upon an integrated systems-biology platform, The Hamner has broadened its mission to include translational research in biopharmaceutical safety, metabolic disorders, and oncology. The site also includes an Accelerator, which houses emerging companies and provides opportunities to develop collaborative research and educational programs with academia, industry, and government. The Hamner model for translational research and technology development integrates innovative science with business development while capitalizing on academic and industry partnerships. The Hamner supports the discovery of new, safer drugs and formation of new companies, which leads to research-based public health policy and enhanced economic development. For more information, visit www.thehamner.org or call (919) 558-1200.

The Hamner Media Contact:
Ryal Curtis
MMI Public Relations
(919) 233-6600

NC State University News Services:
Mick Kulikowski
(919) 515-8387

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