Influenza
AVI is applying our leading RNA-based technology platform to the research and development of therapeutic drug candidates against influenza viruses. AVI-7100 is our lead influenza therapeutic drug candidate and was developed using our patented PMOplus™ technology that attaches positionally specific positive charges to its PMO, or phosphorodiamidate morpholino oligomer, backbone to improve selective interaction between the drug and its target. This is the same chemistry used to generate our investigational drug candidates against hemorrhagic fever viruses. We believe AVI-7100 has significant potential as a broad-spectrum influenza therapeutic since the target is well conserved across various influenza A strains, including seasonal flu strains.
The influenza program is supported by contracts with the U.S. Defense Threat Reduction Agency (DTRA) and conducted in cooperation with the U.S. Department of Defense’s Transformational Medical Technologies program (TMT). We have received funding commitments from the U.S. government totaling up to approximately $20 million to advance the development of AVI-7100 through an IND and to preclinically evaluate its therapeutic potential against the H1N1 (pandemic flu), H5N1 (avian flu), H3N2 (seasonal flu) and Tamiflu™ resistant flu strains.
Please see our Biodefense Programs for more information.
Development Status
In 2009 TMT contracted a Rapid Response Exercise with AVI against a real-world emerging threat, the pandemic H1N1 virus, or swine flu. The intent of the exercise was to demonstrate our capability to efficiently respond to a real-world emerging viral threat by rapidly designing and producing multiple therapeutic candidates and evaluating their preclinical efficacy.
Initially the exercise involved identifying target sequences against H1N1, designing several drug candidates utilizing proprietary derivatives of our PMO chemistry and then manufacturing the candidates in sufficient quantity for preclinical testing. This was successfully accomplished in approximately one week, demonstrating our ability to rapidly respond to a real-world viral threat utilizing our RNA-based therapeutics platform.
Subsequently, we evaluated our RNA-based drug candidates in preclinical studies using a mouse model of seasonal flu and identified AVI-7100, our lead influenza therapeutic drug candidate that employs our patented PMOplus™ technology. We then conducted two preclinical in vivo studies of AVI-7100 utilizing a fully virulent human pandemic H1N1 virus in a ferret model.
The preclinical studies demonstrated improved clinical signs and reduced viral titers in animal models infected with pandemic H1N1 or H3N2 viruses, and there was statistically significant activity as compared to saline and Tamiflu controls.
In April 2010 (Read Press Release) we received increased funding from DTRA to support continued preclinical development of AVI-7100 against multiple influenza virus strains, including Tamiflu resistant influenza. In June 2010, (Read Press Release) we entered into a new contract with DTRA to advance the development of AVI-7100, including studies enabling an Investigational New Drug (IND) application with the U.S. Food and Drug Administration.
AVI initiated a Phase 1 study of AVI-7100 in June of 2011.
About Pandemic H1N1 Influenza
In June 2009, the World Health Organization declared a pandemic of H1N1 influenza. The virus was first detected in people in the U.S. in April 2009 and was referred to as “swine flu” because many of the genes in the virus were very similar to those found in flu viruses that circulate in pigs. Illness with the 2009 H1N1 virus has ranged from mild to severe. Symptoms include fever, cough, runny nose, headache, chills and fatigue. Many people infected with H1N1 also have respiratory symptoms without a fever. Severe illness and deaths have also occurred.
The Centers for Disease Control and Prevention (CDC) estimated that between April 2009 and April 2010 there were up to 89 million cases of H1N1 infection in the U.S. The CDC also estimated that there were up to 403,000 H1N1-related hospitalizations in the U.S. during the same time period.
The information set forth above is current only as of the dates noted. While we will make reasonable attempts to keep the information current, there is no guarantee that we will be successful and, except as required under applicable federal and state laws, we disclaim any obligation to do so. Readers are invited to visit the press release and SEC documents sections of this website for more up to date information about the Company and its research, development and clinical programs as well as other aspects of its business.
This page was last updated on September 19, 2011.
