AVI BioPharma Announces Significant Advance in the Potential Treatment of Ebola and Marburg Virus Infections
May 13 2008 - 9:00AM
Marketwired
PORTLAND, OR today announced that treatment of non-human
primates with either the antisense drug AVI-6002 or with the
antisense drug AVI-6003, resulted in a reproducible and high rate
of survival in the face of an otherwise lethal infection with Ebola
or Marburg virus, respectively.
In repeated trials, monkeys were dosed with well-tolerated
amounts of drug and survived a challenge of roughly 1000 times the
minimum lethal dose. This level of infectious challenge normally
results in uniform death of unprotected monkeys within 7 to 10
days. Treatment of Ebola infected animals with AVI-6002 resulted in
75 percent survival of the infected animals at 15 days post
infection when the treatment period ended and circulating viral
titer was below detectable levels. Treatment of Marburg infected
animals with AVI-6003 resulted in 100 percent survival at 15
days.
The studies utilized experimental drugs based on a novel
variation of AVI's proprietary NeuGene� chemistry referred to as
NeuGene Plus in which anti-viral potency was enhanced by the
addition of positively-charged components to the morpholino
backbone. These new data are a result of continued studies
conducted in collaboration with the US Army Medical Research
Institute of Infectious Diseases (USAMRIID).
"Since the discovery of these viruses in 1967, no prior
therapeutic approach has resulted in this level of survival in
non-human primates," said Colonel George W. Korch, Jr., commander
of USAMRIID. "We look forward to working with AVI to advance these
drug candidates with the ultimate goal of submitting them for FDA
approval."
"Ebola and Marburg are highly lethal viruses that must be
handled in a biosafety level 4 laboratory," said Leslie Hudson,
Ph.D., Chief Executive Officer of AVI. "Given that no effective
therapeutic currently exists, we feel an ethical obligation to
disclose these important observations now, with full results to be
published in the peer-reviewed scientific literature."
The collaborative research effort between AVI and USAMRIID has
been supported by a research contract, "A New Antiviral (Antisense)
Platform Targeting Hemorrhagic Fever Viruses" from the Department
of Defense's Transformational Medical Technologies Initiative. In
addition to development of antiviral agents for Ebola and Marburg,
AVI is receiving government funds to develop antiviral agents to
treat Junin virus under this contract. Under separate government
agreements, AVI is receiving support for programs in Dengue virus,
anthrax and ricin, and additional applications in Ebola and
Marburg.
About Ebola Zaire and Marburg Viruses
Ebola Zaire virus has been the most frequent cause of field
outbreaks of Ebola hemorrhagic fever and is endemic to sub-Saharan
Africa. Ebola hemorrhagic fever is a rare disease that can be
fatal. Outbreaks first occurred in 1976 in Zaire and in western
Sudan. A recent outbreak occurred in November of 2007 in Uganda
ending in January of 2008. Infected individuals develop high
fevers, headache, muscle aches, vomiting, and abdominal cramping.
In fatal infections, bleeding is observed from the nose, eyes,
rectum and urethra. There is uniform mortality once hemorrhagic
signs appear as a result of exposure to the Ebola Zaire virus.
Marburg virus is the cause of Marburg hemorrhagic fever, a rare
disease that occurs naturally in sub-Saharan Africa. Marburg
hemorrhagic fever was first described in 1967 when outbreaks in
Germany and the former Yugoslavia were linked to monkeys imported
from Uganda. The symptoms include fever, diarrhea, vomiting,
massive bleeding from multiple organs and shock. Death generally
occurs between 5 and 10 days after the onset of symptoms.
Marburg and Ebola virus are both members of the filoviridae
viral family and both are National Institutes of Allergy and
Infectious Disease (NIAID) priority A pathogens and bioterrorism
suspect agents of interest to Bioshield.
About USAMRIID
USAMRIID, located at Fort Detrick, Maryland, is the lead medical
research laboratory for the U.S. Department of Defense 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 AVI BioPharma
AVI BioPharma develops therapeutic products for the treatment of
life-threatening diseases using third-generation NeuGene� antisense
drugs and ESPRIT directed RNA alternative splicing technology.
AVI's ESPRIT technology is initially being applied to potential
treatments for Duchenne muscular dystrophy. AVI's NeuGene compounds
are also designed to treat cardiovascular restenosis in stent and
coronary artery bypass graft (CABG) procedures. 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 Marburg Musoke and Ebola
Zaire viruses. More information about AVI is available at
www.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.
The information contained in this press release does not
necessarily reflect the position or the policy of the Government
and no official endorsement should be inferred.
AVI Press and Investor Contact: Michael Hubbard Email Contact
Director of Corporate Communications (503) 227-0554
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