IND Filed for CRA-024781, a Novel Histone Deacetylase Inhibitor
May 3, 2005, 09:50, Reviewed by: Dr.
|HDAC inhibitors target HDAC enzymes and inhibit the proliferation of cancer cells and induce cancer cell death, or apoptosis.
Celera Genomics (NYSE:CRA), an Applera Corporation business, today announced that it has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for CRA-024781, a novel histone deacetylase (HDAC) inhibitor. Pending clearance by the FDA, Celera Genomics plans to initiate Phase 1 clinical trials.
HDAC inhibitors target HDAC enzymes and inhibit the proliferation of cancer cells and induce cancer cell death, or apoptosis(1).
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.
"We're pleased with the progress we've made in advancing CRA-024781 through its preclinical experiments to this point," said Robert Booth, Ph.D., Chief Scientific Officer of Celera Genomics. "We anticipate that we will utilize the insights we have gained from the identification of potential biomarkers of efficacy to design and implement our clinical trials, the first of which is planned to assess the safety and pharmacokinetics of CRA-024781 in a dose escalation study, at a projected cost of less than $3 million."
"Today's accomplishment reflects Celera's successful transition from sequencing the human genome and selling data to focusing on the realization of downstream value in therapeutics and diagnostics," said Kathy Ordonez, President of Celera Genomics. "While the Online/Information Business was important to Celera Genomics in its initial years, it is no longer strategically relevant and has been a source of cash consumption, estimated to be approximately $7 million for fiscal 2005, since many of the subscriptions were prepaid."
"Celera Genomics now has three important strategic assets. First, our proteomics platform continues to yield novel cancer targets that have been the focus of several partnerships for drug discovery and development, allowing us to advance them cost effectively. Secondly, and with today's achievement of filing for an IND with the FDA, our small molecule capability and pipeline of compounds is now sufficiently mature to look to partner and capitalize on this asset. Finally, Celera Diagnostics, a 50-50 joint venture with Applied Biosystems, is generating substantial product sales and making important discoveries for incorporation into future new products," Ms Ordonez added. "With the anticipated discontinuation of the Online/Information Business, Celera Genomics is now in a position to focus its efforts on its most substantial opportunities while managing its use of cash."
Celera Genomics has another compound, a Cathepsin K inhibitor, in a Phase I clinical trial as a potential treatment for osteoporosis. This compound is partnered with Merck, and has been in clinical trials since July 2004. This followed a multi-year collaboration with Merck to develop small molecule inhibitors of Cathepsin K, which was initiated in November 1996.
- U.S. Food and Drug Administration (FDA)
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.
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 their ability to protect trade secrets, and the risk to them 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.
David Speechly, Ph.D., 510-749-1853
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