This agreement is a follow-on to a previous program in which the ITN and Applied Biosystems developed a set of functionally validated gene expression assays based on genes predicted to be involved in the modulation of the immune response. In the latest agreement, Applied Biosystems, through its Knowledge Business Genomics Services group, is expected to analyze the set of approximately 1,000 assays in specimens taken from ITN sponsored clinical trials. Under the agreement, ITN will make public the list of genes and clinical trial protocols and Applied Biosystems intends to provide commercial access to the complete assay set by this Spring through its Assays-on-Demand
ITN intends to use the gene expression data derived from these studies to assess relative expression levels of genes between normal controls and patients, and in single patients at various time points throughout the clinical trials. The data is expected to be used to track parameters such as disease onset, disease progression and patient responses to therapeutics. It is hoped that these studies will result in a better understanding of the mechanisms that relate to the induction, loss and/or maintenance of tolerance and identify new genetic markers for tolerance in humans. Ultimately, this marriage of clinical and genetic sciences in the tolerance arena is designed to improve therapeutic options in organ transplantation, autoimmune diseases, and allergy and asthma.
"The completion of the human genome sequence has provided researchers with a more powerful means to study the underlying mechanisms of disease," said Deborah A. Smeltzer, Vice President of the Knowledge Business for Applied Biosystems. "An important part of our business strategy is to leverage the Applera Genomics Initiative and provide valuable genomic tools necessary for translating genomic sequence data into clinically relevant information. Our work with the ITN should provide valuable insight into the modulation of immune response for immunology researchers."
"Right now we know more about the immune response in mice than we do in people. We now have a very powerful tool that, when incorporated into the ITN's extensive clinical trial program, should provide our first real portrait of the genetic regulation of human immune responses and their response to therapy," said Vicki Seyfert-Margolis, Director of Tolerance Assays of the ITN.
Applied Biosystems Genomic Services
The Applied Biosystems Knowledge Business, formed in April 2002, is focused on generating value to life science customers through products and services with high information content that support improved experimental research workflows. Through its Genomic Services group, the Knowledge Business offers custom services designed to meet clients' specific research needs, including high-throughput sequencing, gene expression measurement using custom assay sets, and SNP discovery and genotyping services. The Assays-on-Demand
About Applera Corporation and Applied Biosystems
Applera Corporation comprises two operating groups. The Applied Biosystems Group develops and markets instrument-based systems, reagents, software, and contract services to the life science industry and research community. 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 $1.6 billion during fiscal 2002. The Celera Genomics Group (NYSE:CRA), located in Rockville, MD, and South San Francisco, CA, is engaged principally in integrating advanced technologies to discover and develop new therapeutics. Celera intends to leverage its proteomic, bioinformatic, and genomic capabilities to identify and validate drug targets and diagnostic marker candidates, and to discover and develop new therapeutics. Its Celera Discovery System
About The Immune Tolerance Network
The Immune Tolerance Network is a seven year, $165 million dollar clinical research program headquartered at the University of California San Francisco and founded in October 1999 to accelerate the development of immune tolerance therapies in kidney, liver and islet transplantation, autoimmune diseases and allergy & asthma. The ITN solicits proposals for clinical trials and mechanistic studies from academic and industry-based researchers in a year-round, open call for proposals. At present, the ITN is overseeing more than a dozen clinical trials and operates several assay facilities at centers around the globe. The ITN is jointly sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), the National Institute of Diabetes and Digestive and Kidney Disease (NIDDK) and the Juvenile Diabetes Research Foundation. More information may be found at http://www.immunetolerance.org/.
Certain statements in this press release are forward-looking. These may be identified by the use of forward-looking words or phrases such as "expect," "intend," "should," and "planned," among others. These forward-looking statements are based on Applera Corporation's current expectations. The Private Securities Litigation Reform Act of 1995 provides a "safe harbor" for such forward-looking statements. In order to comply with the terms of the safe harbor, Applera Corporation notes that a variety of factors could cause actual results and experience to differ materially from the anticipated results or other expectations expressed in such forward-looking statements. These factors include but are not limited to (1) unproven utility of gene expression data in clinical trial monitoring; (2) rapidly changing technology and dependence on development of new products; (3) claims for patent infringement; (4) uncertainty of the availability of intellectual property protection and the ability to protect trade secrets, and the risk of infringement claims; and (5) other factors that might be described from time to time in Applera Corporation's filings with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and Applera does not undertake any duty to update this information, including any forward-looking statements, unless required by law.
Copyright© 2003. Applera Corporation. All rights reserved. Applied Biosystems is a registered trademark and Applera, Assays-on-Demand, Celera, Celera Diagnostics, Celera Discovery System and Celera Genomics are trademarks of Applera Corporation or its subsidiaries in the U.S. and certain other countries.