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Celera Compound Enters Development for Chagas' Disease; Joint Sponsorship by UCSF, NIH and Nonprofit Institute for OneWorld Health.


Business Editors

BIOWIRE2K

ROCKVILLE, Md. & SAN FRANCISCO--(BW HealthWire)--Feb. 14, 2002

Celera Genomics (NYSE NYSE

See: New York Stock Exchange
:CRA See Community Reinvestment Act. ), an Applera Corporation business, announced today that the Institute for OneWorld Health The Institute for OneWorld Health is a 501(c)(3) nonprofit pharmaceutical company founded in 2000 to develop safe, effective, and affordable new medicines for people with infectious diseases in the developing countries.  (IOWH IOWH Institute for One World Health (San Francisco, CA) ) and the National Institutes of Health (NIH "Not invented here." See digispeak.

NIH - The United States National Institutes of Health.
) have initiated development of CRA-3316 as a potential new treatment for Chagas' Disease Chagas' disease, disease of South and Central America caused by the parasite Trypanosoma cruzi. It usually affects children and young adults and is transmitted by the feces of infected insects, typically the assassin bug. . CRA-3316 is a cysteine cysteine (sĭs`tēn), organic compound, one of the 20 amino acids commonly found in animal proteins. Only the l-stereoisomer participates in the biosynthesis of mammalian protein.  protease inhibitor protease inhibitor (prō`tē-ās'), any of a class of drugs that interfere with replication of the AIDS virus (HIV), by blocking an enzyme (protease) necessary in the late stages of its reproduction.  discovered by the Celera research team. Celera has given IOWH the exclusive license to develop the compound for parasitic infections in humans, free of any royalty fees or cash payments. More details regarding Chagas' Disease, CRA-3316, and this collaboration are available on the Celera Genomics website at http://www.celera.com/company/home.cfm?ppage=press.

Celera indicated that IOWH, in conjunction with the NIH, believes that this compound could represent a therapeutic strategy that is affordable, appropriate for short-term administration, and potentially effective in eradicating the disease. As a result, IOWH has agreed to sponsor all development activities, including production of drug substance, IND-enabling safety studies, and Phase I clinical trials. IND-enabling studies of CRA-3316 are currently underway with a goal of evaluating the compound in humans beginning in 2002. If clinical trials are successful, the compound could represent the first new treatment for Chagas' Disease in decades, and a proof-of-concept breakthrough for inhibiting cysteine proteases in other parasitic organisms.

Dr. Victoria Hale, CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board.  and founder of IOWH stated: "IOWH drug development scientists are very excited to enable the early clinical development of CRA-3316 for Chagas' Disease and provide the needed proof of concept for targeting cysteine proteases for other parasitic diseases. We appreciate Celera's contribution to this effort. This collaboration should serve as a model for developing promising anti-parasitic compounds in the future."

Chagas' Disease is a parasitic infection estimated to afflict 16-18 million individuals in South and Central America, with an annual mortality rate of 50,000, based on figures provided by the Centers for Disease Control. The parasite, Trypanosoma cruzi Trypanosoma cru·zi
n.
A protozoan that is the causative agent of South American trypanosomiasis.
, is related to the agent responsible for African sleeping sickness Af·ri·can sleeping sickness
n.
African trypanosomiasis.
, and it depends on a cysteine protease protease /pro·te·ase/ (pro´te-as) endopeptidase.

pro·te·ase
n.
Any of various enzymes, including the proteinases and peptidases, that catalyze the hydrolytic breakdown of proteins.
, cruzain, to sustain its life cycle. The compound, CRA-3316, targets the major protease produced by a parasite that causes Chagas' Disease.

According to Professor James McKerrow at the University of California, San Francisco Coordinates:  , inhibition of cruzain by CRA-3316 is lethal to the parasite that causes the Chagas' infection, but does not harm the treated patients because humans do not have this enzyme. Standard therapies for the disease cannot be used for chronic infections due to toxicity, and can only be used for up to four months, in acute phases of the disease.

Dr. Jim Palmer, senior director of Medicinal Chemistry at Celera, an inventor of this class of compounds, noted, "The acute nature of parasite-borne infections suggests that short-term treatment by irreversible inhibitors such as CRA-3316 may be a viable approach. We would expect a very short course of CRA-3316 therapy based on results obtained thus far, with eradication of the parasitic infection." Palmer also indicated that Professor McKerrow has assembled an extensive body of preclinical evidence to demonstrate the potential of the approach.

The compound CRA-3316, formerly referred to as APC-3316, is covered by US Patent 6,287,840 issued to Celera September 2001, entitled "Irreversible cysteine protease inhibitors Protease Inhibitors Definition

A protease inhibitor is a type of drug that cripples the enzyme protease. An enzyme is a substance that triggers chemical reactions in the body.
 containing vinyl groups conjugated conjugated
adj.
Conjugate.


estrogens, conjugated Warning - Hazardous drug!

C.E.S.
 to electron withdrawing groups," (Palmer; J. T.; Rasnick; D.; Klaus; J. L., inventors).

Celera, through its acquisition of Axys Pharmaceuticals, Inc., of South San Francisco South San Francisco, city (1990 pop. 54,312), San Mateo co., W Calif.; inc. 1908. South San Francisco has several industrial parks; its manufactures include medical supplies and equipment, foods, paint, paper products, consumer goods, and clothing. , Calif., has an extensive background in the discovery and development of protease inhibitors. The inhibition of proteases that cause disease has been the focus of the South San Francisco medicinal chemistry group since the mid-1990s, and has lead to important drug development opportunities in osteoporosis, rheumatoid arthritis rheumatoid arthritis

Chronic, progressive autoimmune disease causing connective-tissue inflammation, mostly in synovial joints. It can occur at any age, is more common in women, and has an unpredictable course.
, asthma, atherosclerosis, and oncology. The development and commercialization of drugs from some of these programs are in partnerships with global pharmaceutical companies, including Aventis and Merck, while other programs remain unpartnered.

IOWH is a non-profit company of pharmaceutical scientists whose mission is to develop affordable, essential new drugs for neglected diseases throughout the world. IOWH's primary target is parasitic disease affecting the developing world, for which there are currently no therapies or inadequate therapies. Dr. Hale formed IOWH seeking to obtain promising drug candidates from pharmaceutical companies, NGOs and universities and to use nonprofit resources to develop and distribute the drugs at cost. She sees this as a "win-win" effort in which new drug therapies for neglected diseases get to those in need at prices they can afford without economic stress imposed on the for-profit pharmaceutical industry. Information about IOWH is available on the World Wide Web at www.oneworldhealth.org.

About Applera Corporation and Celera Genomics

Applera Corporation comprises two operating groups. The Celera Genomics Group, headquartered in Rockville, Md., is engaged principally in integrating advanced technologies to create therapeutic discovery and development capabilities for internal use and for its customers and collaborators. Celera's businesses are its online information business and its therapeutics discovery business. The online information business is a leading provider of information based on the human genome and other biological and medical information. Through the therapeutic discovery business, Celera intends to leverage its genomic and proteomic capabilities to identify drug targets and diagnostic marker candidates, and to discover novel therapeutic candidates. 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.
) develops and markets instrument-based systems, reagents, software, and contract services to the life science industry and research community. Applied Biosystems is headquartered in Foster City, Calif., and reported sales of $1.6 billion during fiscal 2001. Celera Diagnostics, a joint venture between Applied Biosystems and Celera Genomics, is focused on discovery, development, and commercialization of novel diagnostics tests. Information about Applera Corporation, including reports and other information filed by the company with the Securities and Exchange Commission, is available on the World Wide Web at www.applera.com, or by telephoning 800/762-6923. Information about Celera is available on the World Wide Web 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," "anticipate," "should," "planned," "estimated," and "potential," 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 factors include, but are not limited to (1) the lengthy and uncertain development cycle for therapeutic and diagnostic products, and Celera Genomics' unproven ability to develop or commercialize such products; (2) the risk that the collaborations established by Axys will not be successful and that clinical trials will not proceed as anticipated or may not be successful; and (3) other factors that might be described from time to time in Applera Corporation's filings with the Securities and Exchange Commission.

Note to Editors: Applied Biosystems, Celera, Celera Diagnostics and Celera Genomics are registered trademarks of Applera Corporation or its subsidiaries in the U.S. and certain other countries.
COPYRIGHT 2002 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2002, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Geographic Code:1USA
Date:Feb 14, 2002
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