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Celera Genomics Initiates Phase I Clinical Trial for its Novel HDAC Inhibitor, CRA-024781, in Patients with Cancer
Rockville, MD - July 13, 2005
Celera Genomics (NYSE:CRA), an Applera Corporation business, today announced the initiation of Phase I clinical testing for its novel histone deacetylase (HDAC) inhibitor, CRA-024781, in patients with refractory solid malignancies. The Phase I trial of CRA-024781 is a dose-escalation study, and is being conducted by Dr. Samir Undevia at the University of Chicago Hospitals in the Section for Hematology/Oncology. The objectives of the study are to determine the maximum tolerated dose and to evaluate the safety and pharmacokinetics of CRA-024781. Up to 40 patients will be enrolled in this study.
Celera Genomics has another HDAC inhibitor candidate drug, CRA-026440, which is proceeding through preclinical development. Additionally, Celera Genomics has another program in the lead optimization stage to develop other novel variants of HDAC inhibitors, which may be more selective in their mechanism of action in targeting cancer.
“We’re delighted with the initiation of Celera’s first clinical trial with CRA-024781, which has been approved under our first Investigational Drug Application filed with the FDA in May 2005,” said Robert Booth, Ph.D., Chief Scientific Officer of Celera Genomics. “Based on insights we have gained from our preclinical work on this compound, we plan to evaluate potential biomarkers in the clinic to enhance our understanding of its mechanism of action. We also hope that these potential biomarkers may provide a surrogate marker for the efficacy of CRA-024781 in subsequent clinical trials.”
About CRA-024781
HDAC inhibitors target HDAC enzymes resulting in inhibition of the proliferation of cancer cells and induction of cancer cell death or apoptosis1. Celera Genomics recently reported data at the American Association for Cancer Research (AACR) meeting in April 2005, showing the efficacy of CRA-024781 as an HDAC inhibitor in xenograft cancer models. In addition, it was demonstrated that the measurement of tubulin and histone acetylation can be used to monitor the pharmacodynamic effects of CRA–024781 in vivo.
Histone deacetylation is carried out by a family of related HDAC enzymes. Inhibition of these enzymes causes changes to chromatin structure and to gene expression patterns, which results in the inhibition of proliferation of cancer cells, and induction of apoptosis. Celera Genomics published the first three-dimensional structure of an HDAC enzyme in July 2004, and this information has been used to aid the design of a series of novel HDAC inhibitors.
About Celera Genomics and Applera Corporation
Applera Corporation consists of two operating groups. The Celera Genomics Group 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. The Applied Biosystems Group (NYSE:ABI) 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. 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 www.applera.com, or by telephoning 800.762.6923. Information about Celera Genomics is available at www.celera.com.
Forward-Looking Statements
Certain statements in this press release are forward-looking. These may be identified by the use of forward-looking words or phrases such as “believe,” “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 risks and uncertainties include but are not limited to: (1) Celera Genomics’ unproven ability to discover, develop, or commercialize proprietary therapeutic products; (2) the risk that clinical trials of products that Celera Genomics does discover and develop will not proceed as anticipated or may not be successful, or that such products will not receive required regulatory clearances or approvals; (3) the uncertainty that Celera Genomics’ products will be accepted and adopted by the market, including the risk that that these products will not be competitive with products offered by other companies, or that users will not be entitled to receive adequate reimbursement for these products from third party payors such as private insurance companies and government insurance plans; (4) uncertainty of the availability to Celera Genomics of intellectual property protection, limitations on its ability to protect trade secrets, and the risk to it 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.
1. Johnstone, RW. Histone-Deactylase Inhibitors: Novel drugs for the treatment of cancer. Nature Reviews Drug Discovery, 2002, 1:287-299.
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