AVI BioPharma Strengthens Scientific Advisory Board to Address Infectious Disease and Avian Influenza; Three New Members Bring Specific Expertise in Emerging Infectious Diseases
PORTLAND, Ore.--(BUSINESS WIRE)--Nov. 17, 2005--AVI BioPharma, Inc. (Nasdaq:AVII), today announced the addition of three new members to its Scientific Advisory Board to specifically address the potential emergence of avian influenza type H5N1.
Klaus O. Schafer, M.D., MPH, is the former deputy assistant to the Secretary of Defense for Chemical and Biological Defense. In this position, Dr. Schafer oversaw the $2.1 billion annual science, technology, research, development and acquisition program in the area of medical and nonmedical materials for chemical biological defense for the entire U.S. Department of Defense. Dr. Schafer worked closely with Congress, international partners and other federal agencies in this key position. A graduate of the U.S. Air Force Academy in Colorado Springs, Colo., he earned his doctor of medicine degree from the University of Iowa Medical School and a master of public health degree at the University of Texas Health Center. He currently serves as a founding partner of Tessarae, Inc., a manufacturer of equipment for the genomics marketplace.
David N. Gilbert, M.D., MACP, is a professor of medicine at Oregon Health & Science University (OHSU) and the William M. Garnjobst Chair of Graduate Medical Education and director of the Earle A. Chiles Research Institute for Providence Portland Medical Center. He is also the chief of the Infectious Diseases Program at the Providence Portland Medical Center. He formerly served as president of the following: the Infectious Diseases Society of America, the Oregon Chapter of the American College of Physicians, the Infectious Diseases Consortium of Oregon and the Infectious Diseases Society of Oregon. The University of Washington awarded Dr. Gilbert his undergraduate degree in zoology, and he received his medical degree at University of Oregon Medical School, where he graduated cum laude.
Thomas G. Voss, Ph.D., is currently an assistant professor in the department of microbiology and immunology at Tulane University School of Medicine. Before that, he was vice president and chief scientist of the Homeland Security and Infectious Disease Research Division for Southern Research Institute in Birmingham, Ala. He received his undergraduate degree from the University of Texas, and his Ph.D. in the field of microbiology and immunology from Tulane University School of Medicine. His current research involves developing animal models for testing vaccines, diagnostics and therapeutics against biodefense and emerging infectious diseases, including avian influenza. His previous research involves developing novel approaches for the treatment of anthrax, screening antiviral drugs against SARS coronavirus, and developing in vitro and animal models for testing the efficacy of innate immunity activators for prevention of infection and disease by viral, bacterial and other infectious agents.
"It is an honor to have these men join our Scientific Advisory Board," said Denis R. Burger, Ph.D., chief executive officer of AVI. "While the knowledge and experience each man brings is substantial in its own right, together they provide a tremendous body of expertise that we can benefit from as we move forward with our avian influenza drug development program."
AVI previously announced a NEUGENE(R) antisense drug development program targeting the influenza A (flu) virus, specifically genetic regions of the virus that are highly conserved between six viral subtypes that cause human disease. These include three subtypes that caused pandemics in the 20th century -- the 1918 Spanish flu (H1N1), the 1957 Asian flu (H2N2) and the 1968 Hong Kong flu (H3N2) -- and three subtypes of avian flu that have been reported to cause disease in humans (H5N1, H7N7 and H9N2). Several NEUGENE antisense compounds have been efficacious in preclinical experiments and will now move to animal trials against H1N1 and H5N1.
"Using our targeted approach to blocking replication of the influenza virus, we believe that a single NEUGENE drug could be effective against a variety of influenza subtypes, not just the H5N1 variant of avian flu," said Patrick L. Iversen, Ph.D., senior vice president of research and development at AVI. "By targeting regions of the viral genetic code that are common to all influenza A subtypes, we expect that our NEUGENE drug against avian flu will also be effective against the far more common influenza A virus H1N1, which kills an average of 35,000 Americans every year."
AVI's Antiviral Program
AVI's proprietary NEUGENE antisense drug candidates have demonstrated efficacy in preclinical studies against SARS coronavirus, West Nile virus (WNV), hepatitis C virus (HCV), dengue virus, Ebola virus, and Marburg virus. AVI has filed Investigational New Drug (IND) applications with the U.S. Food and Drug Administration and has ongoing clinical trials in WNV and HCV.
Showing how versatile NEUGENE drugs can be across viral subtypes, AVI demonstrated in its collaboration with the Centers for Disease Control and Prevention that NEUGENE agents are efficacious against all four immunologically distinct subtypes of the dengue virus. This outcome was achieved by targeting a highly conserved region of the dengue viral genetic code. In collaborative work with the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID) targeting the Ebola virus, NEUGENE drugs protected three animal species from lethal challenges with this virus. Additional clinical development efforts targeting dengue virus and Ebola virus are planned for 2006.
The speed with which effective NEUGENE drugs can be designed and manufactured exceeds any other modern drug development timeframe. For example, NEUGENE compounds targeting SARS, WNV and Ebola were developed within days to weeks of obtaining the appropriate genetic sequences for the viruses.
AVI's Clinical Experience
AVI's NEUGENE antisense drugs have a well-defined safety record in human clinical trials. Approximately 250 patients have been dosed with NEUGENE drug candidates targeting host and viral gene targets in 11 clinical studies under multiple INDs. Five different routes of administration have been employed in AVI's clinical studies, and doses up to 450 mg have been administered without a single drug-related, serious adverse event. The combination of AVI's NEUGENE chemistry with conserved viral targets that are not expressed in the human genome makes a strong case for the potential for success in the development of candidates to address the possible emergence of a transmittable avian flu.
About Influenza A Viruses
Influenza, or flu, is a contagious respiratory illness caused by influenza viruses. On average 5 percent to 20 percent of the U.S. population is infected with the flu each year. Influenza A virus is an enveloped negative-strand RNA virus, with eight genome segments that code for 10 proteins. Influenza strains are subtyped according to the antigenic and genetic nature of their surface glycoproteins: hemagglutinin (HA or H) and neuraminidase (NA or N). Fifteen H and nine N subtypes have been identified, with three associated with widespread human disease (H1N1, H2N2 and H3N2). In addition, several subtypes of avian influenza virus -- H5N1, H7N7 and H9N2 -- can infect and cause disease in humans.
The current influenza pandemic in birds throughout Asia and in Eastern Europe is caused by the H5N1 subtype. It is thought that co-infection of humans or certain animals (such as pigs) with both H1N1 and H5N1 can lead to a reassortment or recombination of viral particles, resulting in the emergence of a virus with dangerous public health properties, namely one to which the human population has no natural immunity and which has the ability to spread easily from person to person. It is believed that emergence of avian flu by this general mechanism may have led to the worldwide pandemics of 1918, 1957 and 1968.
About AVI BioPharma
AVI BioPharma develops therapeutic products for the treatment of life-threatening diseases using third-generation NEUGENE antisense drugs. AVI's lead NEUGENE antisense compound is designed to target cell proliferation disorders, including cardiovascular restenosis, cancer and polycystic kidney disease. In addition to targeting specific genes in the body, AVI's antiviral program uses NEUGENE antisense compounds to combat disease by targeting single-stranded RNA viruses, including West Nile virus, hepatitis C virus, dengue virus and Ebola virus. AVI has introduced a NEUGENE-based exon-skipping technology called ESPRIT therapy. More information about AVI is available on the company's Web site at avibio.com.
"Safe Harbor" Statement under the Private Securities Litigation Reform Act of 1995: 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 preclinical and clinical testing, the effect of regulation by the FDA 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.
CONTACT: AVI BioPharma, Inc.Michael Hubbard, 503-227-0554
hubbard@avibio.com
or
Investor Contacts:
Lippert/Heilshorn & Associates Inc.
Bruce Voss, 310-691-7100
bvoss@lhai.comJody Cain, 310-691-7100
jcain@lhai.com
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Press Contact:
Waggener Edstrom Worldwide
Bioscience and Healthcare Practice
Jenny Moede, 503-443-7000
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SOURCE: AVI BioPharma, Inc. |
