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Celera Genomics Initiates Phase I Clinical Trial for Its Novel HDAC Inhibitor, CRA-024781, in Patients with Cancer.


ROCKVILLE, Md. -- Celera Genomics (NYSE NYSE

See: New York Stock Exchange
:CRA See Community Reinvestment Act. ), an Applera Corporation business, today announced the initiation of Phase I clinical testing for its novel histone deacetylase (HDAC HDAC Histone Deacetylase (biochemistry)
HDAC Heavy Duty Air Cylinder
) 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 The University of Chicago Hospitals form a major center for medical care and research in the Hyde Park neighborhood of Chicago, Illinois. They are affiliated with and run by the University of Chicago, and serve as teaching hospitals for students of the institution's Pritzker  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 FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
 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 apoptosis(1). Celera Genomics recently reported data at the American Association for Cancer Research Wikipedia is not the place for advertisement or self-advertising.

The American Association for Cancer Research (AACR) is an organization based in Philadelphia, Pennsylvania, that focuses on all aspects of cancer research including basic, clinical and translational
 (AACR AACR American Association for Cancer Research
AACR Anglo-American Cataloging Rules
AACR Australasian Association of Cancer Registries
AACR African Armed Conflicts Resolved
) meeting in April 2005, showing the efficacy of CRA-024781 as an HDAC inhibitor in xenograft xenograft /xeno·graft/ (zen´o-graft) a graft of tissue transplanted between animals of different species; it may be concordant,  cancer models. In addition, it was demonstrated that the measurement of tubulin tubulin /tu·bu·lin/ (too´bu-lin) the constituent protein of microtubules.

tu·bu·lin
n.
A globular protein that is the structural constituent of microtubules.
 and histone histone (hĭs`tōn), any of a class of protein molecules found in the chromosomes of eukaryotic cells. They complex with the DNA (see nucleic acid) and pack the DNA into tight masses of chromatin, which have the structure of coiled coils, much  acetylation acetylation /acet·y·la·tion/ (ah-set?i-la´shun) introduction of an acetyl radical into an organic molecule.

a·cet·y·la·tion
n.
 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 chromatin: see chromosome.  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 Abi (ā`bī) [short for Abijah], in the Bible, King Hezekiah's mother.


(Application Binary Interface) A specification for a specific hardware platform combined with the operating system.
) 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 DNA: see nucleic acid.
DNA
 or deoxyribonucleic acid

One of two types of nucleic acid (the other is RNA); a complex organic compound found in all living cells and many viruses. It is the chemical substance of genes.
 and RNA RNA: see nucleic acid.
RNA
 in full ribonucleic acid

One of the two main types of nucleic acid (the other being DNA), which functions in cellular protein synthesis in all living cells and replaces DNA as the carrier of genetic
), 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 The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and  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 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.

Copyright (C) 2005. Applera Corporation. All Rights Reserved. Applied Biosystems, Celera, Celera Diagnostics, Celera Discovery System, and Celera Genomics are trademarks of Applera Corporation or its subsidiaries in the U.S. and/or certain other countries.
(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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No portion of this article can be reproduced without the express written permission from the copyright holder.
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Date:Jul 13, 2005
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