Applied Biosystems and the U.S. Food And Drug Administration Collaborate to Investigate Diabetes Drug Toxicity
Applied Biosystems (NYSE:ABI), an Applera Corporation business, today announced a collaborative research study with the National Center for Toxicological Research of the U.S. Food and Drug Administration (FDA/NCTR) whereby Applied Biosystems will use its Expression Array System and Rat Genome Survey Microarray to investigate the toxicity of a common class of diabetes drugs using samples provided by the FDA/NCTR. Applied Biosystems announced the collaboration in conjunction with the 44th Annual Society of Toxicology Meeting, March 6-10, 2005, at the Ernest Morial Convention Center, New Orleans, LA, U.S.A., where FDA/NCTR and Applied Biosystems will today present early findings from the collaboration during a poster session.
As part of the collaboration, Applied Biosystems will use its Expression Array System to investigate the molecular basis of liver toxicity associated with certain diabetes drugs.
In 2000, troglitazone (Rezulin) was withdrawn from the market due to severe liver toxicity with an unknown mechanism. Troglitazone and other currently marketed drugs, such as rosiglitazone (Avandia®) and pioglitazone (Actos®), are members of a popular class of insulin-sensitizing agents. The mechanism for troglitazone’s hepatotoxicity is currently unknown, and it is also unknown whether or not agents in the same chemical class may cause similar gene expression changes that could lead to similar toxicity.
“Liver toxicity is a leading cause of drug removal from the market,” said William V. Murray, Division President of the Molecular Biology Division for Applied Biosystems. “We look forward to helping the FDA determine the reason for toxicity induced by troglitazone, and to identifying similarities or differences in the gene expression profile triggered by this drug and other marketed or investigational drugs in the same class.”
“We are very excited about this collaboration,” said Weida Tong, Ph.D., Director of Center for Toxicoinformatics of the FDA/NCTR. “The Rat Genome Survey Microarray and other technologies developed by Applied Biosystems will provide us additional means to understand the molecular basis of the potential liver toxicity associated with the glitazone-based Type II diabetes drug family.”
In addition to its Expression Array System, Applied Biosystems will use its real-time PCR systems and TaqMan® Gene Expression Assays to validate the results and extend the study of identified biomarkers to other samples. The FDA/NCTR plans to analyze the data to identify specific genes and pathways associated with liver toxicity and use identified toxicity signatures from the microarray data to predict the toxicity of future drugs in the same chemical class.
The FDA/NCTR and Applied Biosystems will today present its findings at the Exhibit Hall on Wednesday, March 9, 2005, in Poster Session: Liver II from 1:30-4:30 p.m. CST. The poster number is 1912 and is entitled “Examination of Mechanism(s) of Hepatotoxicity of Anti-diabetic PPARγ Agonists Using Rat Primary Hepatocyte Cultures and the Applied Biosystems Rat Whole Genome Survey Microarray.”
About Applera Corporation and Applied Biosystems
Applera Corporation consists of two operating groups. The Applied Biosystems Group serves the life science industry and research community by developing and marketing instrument-based systems, consumables, software, and services. Customers use these tools to analyze nucleic acids (DNA and RNA), small molecules, and proteins to make scientific discoveries, develop new pharmaceuticals, and conduct standardized testing. Applied Biosystems is headquartered in Foster City, CA, and reported sales of $1.7 billion during fiscal 2004. The Celera Genomics Group (NYSE:CRA) is engaged principally in the discovery and development of targeted therapeutics for cancer, autoimmune and inflammatory diseases. Celera Genomics is leveraging its proteomic, bioinformatic, and genomic capabilities to identify and validate drug targets, and to discover and develop small molecule therapeutics. It is also seeking to advance therapeutic antibody and selected small molecule drug programs in collaboration with global technology and market leaders. Celera Diagnostics, a 50/50 joint venture between Applied Biosystems and Celera Genomics, is focused on discovery, development, and commercialization of diagnostic products. Information about Applera Corporation, including reports and other information filed by the company with the Securities and Exchange Commission, is available at http://www.applera.com , or by telephoning 800.762.6923. Information about Applied Biosystems is available at http://www.appliedbiosystems.com/ .
