Hemorrhagic Viruses
Under a contract valued at up to approximately $291 million with the U.S. Department of Defense Chemical and Biological Defense Program through the U.S. Army Space and Missile Defense Command, and awarded as part of the Department’s Transformational Medical Technologies (TMT) program, we are developing AVI-6002 and AVI-6003, our lead hemorrhagic fever virus therapeutic candidates for Ebola and Marburg viruses, respectively. AVI-6002 and AVI-6003 use our TSO technology and advanced PMOplus™ chemistry backbone.
AVI-6002 and AVI-6003 have demonstrated positive therapeutic effects, with high survival rates demonstrated in repeat preclinical studies in both the Ebola Zaire and Marburg Musoke viruses. There is currently no effective therapeutic for Ebola or Marburg viruses. The Ebola virus is lethal in more than 80 percent of cases, while the Marburg virus is also lethal in up to 80% or more cases. AVI is also conducting preclinical studies evaluating RNA-based therapeutics against Dengue and Junín viruses, other hemorrhagic viruses, with support from the U.S. government.
Please see our Biodefense Programs for more information.
Development Status
Preclinical results of AVI-6002 and AVI-6003 demonstrated reproducible high rates of survival in non-human primates challenged with a lethal infection of the Ebola and Marburg viruses. Treatment of Ebola-infected animals with AVI-6002 resulted in up to 75 percent survival of the infected animals at 15 days post-infection with circulating viral titer below detectable levels. Treatment of Marburg infected animals with AVI-6003 resulted in 100 percent survival at 15 days
We have open Investigational New Drug (IND) allowances from the FDA for developing our RNA-based drug candidates AVI-6002 and AVI-6003 for the treatment of Ebola and Marburg viruses, respectively.
In February 2010 we submitted two proposals, solicited under a U.S. government request for proposal, or RFP, published in November 2009, for the clinical development of AVI-6002 and AVI-6003 as approved medical countermeasures against the Ebola and Marburg hemorrhagic fever viruses through to U.S. Food and Drug Administration, or FDA, approval. The proposed clinical development of these candidates is pursuant to the FDA’s Animal Efficacy Rule, which is designed to facilitate the development of new drug products for indications in which clinical studies in humans cannot be conducted ethically. According to this rule, marketing approval may be granted based on the demonstration of efficacy in relevant animal species and additional supporting data.
In July 2010 our proposals were granted and we were awarded a new contract for up to approximately $291 million with the U.S. Department of Defense Chemical and Biological Defense Program through the U.S. Army Space and Missile Defense Command, and awarded as part of the Department’s Transformational Medical Technologies (TMT) program, for the advanced development of the our hemorrhagic fever virus therapeutic candidates, AVI-6002 and AVI-6003, for Ebola and Marburg viruses, respectively.
The contract is structured into four segments. Activity under the first segment provides for funding to AVI of up to approximately $80 million and began immediately upon contract award. Activities under the first segment include Phase 1 studies in healthy volunteers as well as preclinical studies, and are scheduled over an 18 month period. After completion of the first segment, and each successive segment, TMT has the option to proceed to the next segment for either or both AVI-6002 and AVI-6003. If TMT exercises its options for all four segments, contract activities would include all clinical and licensure activities necessary to obtain FDA regulatory approval of each therapeutic candidate and would provide for a total funding award to the Company of up to approximately $291 million over a period of approximately 6 years. The contract is the largest ever granted under the TMT program.
Under an earlier U.S. Department of Defense contract the Company completed development activities that culminated in the opening of Investigational New Drug (IND) applications for both AVI-6002 and AVI-6003.
About Hemorrhagic Viruses
About Ebola Hemorrhagic Fever
Ebola hemorrhagic fever is a severe and often fatal disease 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 and symptoms 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.
About Marburg Hemorrhagic Fever
Marburg hemorrhagic fever is a severe and potentially fatal disease in humans first recognized in 1967. It is also caused by an RNA virus of the filovirus 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 dysfunction. There are currently no treatments for Marburg virus infection beyond supportive care.
About Dengue and Dengue Hemorrhagic Fever
Dengue and dengue hemorrhagic fever (“DHF”) are caused by one of four closely related viruses. DHF is a more severe form of dengue which can be fatal. Both diseases are spread via the bite of mosquitos and is now endemic to at least 100 countries in Asia, the Pacific, the Americas, Africa, and the Caribbean. It is estimated that there are 100 million cases of dengue worldwide each year. Symptoms of dengue include high fever, severe headache, joint pain, rash and mild bleeding. Symptoms of DHF include a fever lasting up to 7 days and other symptoms similar to dengue. When the fever declines, symptoms including vomiting, severe abdominal pain and difficulty breathing may develop, and marks a period of time when blood vessels may start to leak and cause bleeding. There is no specific treatment for dengue or DHF.
For more information about Marburg, Ebola Zaire and other hemorrhagic viruses, visit www.cdc.gov.
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 July 31, 2010.
