SOURCE: AVI BioPharma, Inc.

AVI BioPharma, Inc.

March 30, 2012 08:30 ET

Data From AVI BioPharma's Infectious Disease Programs to Be Presented at the 22nd European Congress of Clinical Microbiology and Infectious Diseases

BOTHELL, WA--(Marketwire - Mar 30, 2012) - AVI BioPharma, Inc. (NASDAQ: AVII), a developer of RNA-based therapeutics, today announced the presentation of data from the Company's infectious disease programs at the 22nd Annual European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) taking place in London, United Kingdom from March 31 to April 3. These programs utilize a common platform -- AVI's patented PMOplus® technology.

Alison Heald, M.D., Senior Director of Clinical Development at AVI, will present two posters during Session I, titled "A Phase I, Single Ascending-Dose Study of AVI-6002, a Combination of Two PMOplus® Compounds with Activity Against Ebola Virus" and "A Phase I, Single Ascending-Dose Study of AVI-6003, a Combination of Two PMOplus® Compounds With Activity Against Marburg Virus." Both presentations will be given during the session called "Virology Non-HIV/Non-Hepatitis" and are scheduled at 3:30 p.m. GMT on Saturday, March 31. The presentations will feature data from the single ascending dose studies of AVI's Ebola therapeutic, AVI-6002, and Marburg therapeutic, AVI-6003. These studies exhibited positive safety results for each therapeutic candidate in all six dose cohorts, up to a maximum dose of 9 mg/kg.

Pat Iversen, Ph.D., Senior Vice President of Research and Innovation at AVI, will present a poster during Session I titled "No Mutations Detected With PMOplus® Antisense Oligomers That Protect Nonhuman Primates Against Marburg Virus" at 3:30 p.m. GMT on Saturday, March 31. The poster, which will be given during the session called "Virology - Diagnosis, Epidemiology, Prophylaxis and Therapy," will feature data from animal studies of AVI's lead Marburg therapeutic, AVI-6003, in Marburg infected nonhuman primate models. These preclinical studies, as well as those of AVI-6002, have been a collaborative effort between AVI and scientists at the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID), which has the DOD's only maximum containment, or Biosafety Level 4, capability.

AVI is conducting the work presented in the three previously mentioned posters under a Department of Defense contract managed by the Joint Project Manager Transformational Medical Technologies (JPM-TMT) Project Management Office, a component of the Joint Program Executive Office for Chemical and Biological Defense (JPEO-CBD).

Dr. Iversen will also present two posters featuring data from preclinical studies of AVI's lead influenza therapeutic, AVI-7100, during Session I at 3:30 p.m. GMT on Saturday, March 31. The poster titled "Post Exposure Efficacy of AVI-7100 Against Influenza A in Mouse and Ferret Infection Models" will be given during the session called "Molecular Virology," while the poster titled "Prophylactic Efficacy of AVI-7100 Against Influenza A in Mouse and Ferret Infection Models" will be given during the session called "Virology - Diagnosis, Epidemiology, Prophylaxis and Therapy." Together, the data demonstrate both post exposure and prophylactic efficacy of AVI-7100 in influenza virus-infected mouse and ferret models. AVI-7100 was preclinically developed and identified with support from JPM-TMT.

Finally, Dr. Iversen will present a poster during Session III titled "Peptide Phosphorodiamidate Morpholino Oligomers as Gene-Silencing Antisense Therapeutics for Mycobacterium Tuberculosis" at 1:30 p.m. GMT on Sunday, April 1. The presentation, which will be given during the session called "New Antimicrobial Agents Against Old and New Protein Targets," will feature data demonstrating efficacy of AVI's platform chemistry in Mycobacterium tuberculosis in cell culture studies as part of AVI's program on extensively drug-resistant tuberculosis (XDR-TB). AVI is pursuing this program in collaboration with leading scientists at the Swedish medical university Karolinska Institutet to identify RNA-based therapeutic candidates for the treatment of XDR-TB.

About Ebola and Marburg Viruses
The hemorrhagic fever caused by the Ebola virus is severe and often fatal in humans. The disease was first recognized in 1976 and is one of two members of a family of RNA viruses called Filoviridae. The disease is generally understood to be endemic to parts of Africa. Onset of illness from Ebola virus is abrupt with symptoms that include fever, headache, muscle ache, vomiting and stomach pain. Internal and external bleeding may also be observed in some patients. There are currently no treatments for Ebola virus infection beyond supportive care and the mortality rate is very high.

Marburg hemorrhagic fever is a severe and potentially fatal disease in humans first recognized in 1967. It is caused by an RNA virus of the Filoviridae family and is understood to be endemic to Africa. Onset of the disease is often sudden, and the symptoms include fever, chills, nausea, vomiting, chest pain and diarrhea. Increasingly severe symptoms may also include massive hemorrhaging and multiple organ dysfunctions. There are currently no treatments for Marburg virus infection beyond supportive care and the mortality rate is even higher than that of Ebola infection.

About AVI's PMOplus® Chemistry
PMOplus® chemistry is an advanced generation of AVI's phosphorodiamidate morpholino oligomer, or PMO, technology pioneered by AVI. The PMO platform is designed to provide a stable chemistry backbone with superior drug-like characteristics for AVI's advanced RNA-based therapeutics. PMOplus® chemistry includes the addition of selectively introduced positive charges to the PMO's inherently charge-neutral backbone. PMOplus® is believed to have potentially broad therapeutic applications and has thus far shown to be particularly effective in increasing the potency of PMO-based oligomers.

About JPM-TMT
The Joint Project Manager Transformational Medical Technologies (JPM-TMT) Project Management Office, an organization within the Joint Program Executive Office for Chemical and Biological Defense (JPEO-CBD) aims to protect the Warfighter from emerging infectious diseases, genetically altered and unknown biological threats. Through strategic investments and partnerships with innovative biotech firms, pharmaceutical corporations, other government agencies, and academic institutions, JPM-TMT facilitates the advanced development and acquisition of broad-spectrum medical countermeasures and systems to enhance our nation's biodefense response capability. For more information, visit www.jpmtmt.mil.

About USAMRIID
U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID), located at Fort Detrick, Maryland, is the lead medical research laboratory for the U.S. Department of Defense's Biological Defense Research Program, and plays a key role in national defense and in infectious disease research. The Institute conducts basic and applied research on biological threats resulting in medical solutions (such as vaccines, drugs and diagnostics) to protect the Warfighter. While USAMRIID's primary mission is focused on the military, its research often has applications that benefit society as a whole. USAMRIID is a subordinate laboratory of the U.S. Army Medical Research and Materiel Command. For more information, visit www.usamriid.army.mil.

About Karolinska Institutet
Karolinska Institutet is one of the world's leading medical universities. Its mission is to contribute to the improvement of human health through research and education. Karolinska Institutet accounts for over 40 percent of the medical academic research conducted in Sweden and offers the country's broadest range of education in medicine and health sciences. Since 1901 the Nobel Assembly at Karolinska Institutet has selected the Nobel laureates in Physiology or Medicine. For more information, visit ki.se.

About AVI BioPharma
AVI BioPharma is focused on the discovery and development of novel RNA-based therapeutics for rare and infectious diseases, as well as other select disease targets. Applying pioneering technologies developed and optimized by AVI, the Company is able to target a broad range of diseases and disorders through distinct RNA-based mechanisms of action. Unlike other RNA-based approaches, AVI's technologies can be used to directly target both messenger RNA (mRNA) and precursor messenger RNA (pre-mRNA) to either down-regulate (inhibit) or up-regulate (promote) the expression of targeted genes or proteins. By leveraging its highly differentiated RNA-based technology platform, AVI has built a pipeline of potentially transformative therapeutic agents, including eteplirsen, which is in clinical development for the treatment of Duchenne muscular dystrophy, and multiple drug candidates that are in clinical development for the treatment of infectious disease. For more information, please visit www.avibio.com.

Forward-Looking Statements and Information

In order to provide AVI's investors with an understanding of its current results and future prospects, this press release contains statements that are forward-looking. Any statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Words such as "believes," "anticipates," "plans," "expects," "will," "intends," "potential," "possible" and similar expressions are intended to identify forward-looking statements. These forward-looking statements include statements about the development of AVI's product candidates and the efficacy, potency and utility of AVI's product candidates in the treatment of rare and infectious diseases.

These forward-looking statements involve risks and uncertainties, many of which are beyond AVI's control. Known risk factors include, among others: clinical trials may not demonstrate safety and efficacy of any of AVI's drug candidates and/or AVI's antisense-based technology platform; and any of AVI's drug candidates may fail in development, may not receive required regulatory approvals, or be delayed to a point where they do not become commercially viable.

Any of the foregoing risks could materially and adversely affect AVI's business, results of operations and the trading price of AVI's common stock. For a detailed description of risks and uncertainties AVI faces, you are encouraged to review the official corporate documents filed with the Securities and Exchange Commission. AVI does not undertake any obligation to publicly update its forward-looking statements based on events or circumstances after the date hereof.

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