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AVI BioPharma Initiates Clinical Development of a New Class of Antibiotics.


Business Editors, Health/Medical Writers

PORTLAND, Ore.--(BW HealthWire)--Feb. 17, 2000

New therapeutic class demonstrates additional applications

of AVI's proprietary NEUGENE(R) antisense technology

AVI BioPharma, Inc. (Nasdaq:AVII)(Nasdaq:AVIIW)(Nasdaq:AVIIZ), today announced that it has initiated clinical development of NEUBIOTICS(TM), a new class of antibiotics.

Based on AVI's NEUGENE(R) antisense technology, this new application has demonstrated promising preclinical data as the Company advances toward treating a number of infectious diseases, particularly those which are resistant to current antibiotics.

Denis Denis, king of Portugal: see Diniz.  Burger, Ph.D., President and 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.  of AVI BioPharma, stated, &uot;Remarkable preclinical data has accelerated the clinical development process of our NEUBIOTIC program. With continued positive preclinical results, we look forward to initiating human trials with this new class of antibiotics later this year.&uot;

&uot;One of the most daunting daunt  
tr.v. daunt·ed, daunt·ing, daunts
To abate the courage of; discourage. See Synonyms at dismay.



[Middle English daunten, from Old French danter, from Latin
 medical problems today is the continuing emergence of antibiotic resistance. As more conventional antibiotics are used worldwide, more resistant organisms emerge,&uot; stated David Hinrichs, Ph.D., Professor of Microbiology and Immunology at Oregon Health Sciences University and the U.S. Department of Veterans Affairs Medical Center.

According to Centers for Disease Control and Prevention Centers for Disease Control and Prevention (CDC), agency of the U.S. Public Health Service since 1973, with headquarters in Atlanta; it was established in 1946 as the Communicable Disease Center.  (CDC See Control Data, century date change and Back Orifice.

CDC - Control Data Corporation
) data, antimicrobial resistance affects nearly all the pathogens previously considered to be readily treatable by current antibiotic therapy and costs more than $661 million in hospital charges each year. Drug resistance is a problem in bacterial infections, such as many forms of pneumonia, and in many viral, fungal, and parasitic diseases including malaria.

&uot;Our data indicate that our NEUGENE antisense compounds meet the stringent criteria to be a commercially viable new class of antibiotics to meet this medical challenge,&uot; according to Patrick L. Iversen, Ph.D., AVI's Senior Vice President of Research and Development. &uot;By targeting microbial microbial

pertaining to or emanating from a microbe.


microbial digestion
the breakdown of organic material, especially feedstuffs, by microbial organisms.
 genes that are not found in man we have been able to stop microbial growth, even against antibiotic resistant organisms,&uot; Iversen stated.

AVI's proprietary antisense technology works by stopping or slowing gene action. NEUBIOTICS target a bacterial gene, resulting in inhibition of bacterial proliferation. Resten-NG(TM), another compound based on the NEUGENE platform, that is currently undergoing human clinical trials, works by targeting c-myc, a gene responsible for cell proliferation in mammalian cells.

Manufacturing of AVI's proprietary NEUGENE antisense compounds, under the FDA's current Good Manufacturing Practice Good Manufacturing Practice or GMP (also referred to as 'cGMP' or 'current Good Manufacturing Practice') is a term that is recognized worldwide for the control and management of manufacturing and quality control testing of foods and pharmaceutical products.  (GMP GMP (guanosine monophosphate): see guanine. ), has been initiated with Pharma-Eco of Lexington, Mass. and Boston BioSystems of Bedford, Mass., an Avecia company. Initiation of manufacturing is a critical step toward the filing of Investigational New Drug applications with the U.S. Food and Drug Administration.

Pharma-Eco is a 25 year-old privately held company privately held company

A firm whose shares are held within a relatively small circle of owners and are not traded publicly.
 specializing in the contract manufacturing of small molecule Active Pharmaceuticals Ingredients (API) for the biotech industry under cGMP. Pharma-Eco has made more than 10,000 compounds and has more than 35 Drug Master Files (DMFs) in place with a variety of corporate sponsors.

Boston BioSystems specializes in large-scale oligonucleotide synthesis, with an expertise in non-ionic oligonucleotide drugs, which is particularly relevant to AVI's Morpholine Morpholine is an organic chemical compound having the chemical formula O(CH2CH2)2NH. This heterocycle, pictured at right, features both amine and ether functional groups.  antisense compounds.

AVI BioPharma develops therapeutic products for the treatment of life-threatening diseases using two technology platforms: cancer immunotherapy and gene-targeted drugs. Its lead clinical agent, AVICINE(TM), a therapeutic cancer vaccine, is undergoing a Phase II trial in pancreatic cancer, and will soon enter a Phase III pivotal trial in colorectal cancer and a Phase II trial in prostate cancer. The first application of its NEUGENE(R) compounds, Resten-NG, is designed to treat cancer, cardiovascular restenosis and other cell proliferation disorders by inhibiting the production of a cellular transcription factor, the oncogene oncogene

Gene that can cause cancer. It is a sequence of DNA that has been altered or mutated from its original form, the proto-oncogene (see mutation). Proto-oncogenes promote the specialization and division of normal cells.
 c-myc. It is currently being tested in a Phase I trial. More information about AVI (Audio Video Interleaved) A Windows multimedia video format from Microsoft. It interleaves standard waveform audio and digital video frames (bitmaps) to provide reduced animation at 15 fps at 160x120x8 resolution. Audio is 11,025Hz, 8-bit samples.  is available at http://www.avibio.com.

The statements that are not historical facts contained in this release are forward-looking statements that involve risks and uncertainties, including, but not limited to, the results of research and development efforts, the results of pre-clinical and clinical testing, the effect of regulation by 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.
 and other agencies, the impact of competitive products, product development, commercialization and technological difficulties, and other risks detailed in the Company's Securities and Exchange Commission filings.
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Publication:Business Wire
Date:Feb 17, 2000
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