AVI BioPharma Files IND for Clinical Trial of Marburg Virus Treatment
December 03 2008 - 8:05AM
Marketwired
AVI BioPharma, Inc. (NASDAQ: AVII), a developer of RNA-based drugs,
today announced the filing of an Investigational New Drug
application with the U.S. Food and Drug Administration for a
clinical trial to evaluate the Company's antisense drug AVI-6003
for the treatment of Marburg virus infection. AVI plans to conduct
the trial as part of its continued collaboration with the US Army
Medical Research Institute of Infectious Diseases (USAMRIID).
Preclinical results of AVI-6003 demonstrated a reproducible and
high rate of survival in non-human primates challenged with a
lethal infection of Marburg virus.
"The outstanding results demonstrated in preclinical studies of
AVI-6003 for the treatment of Marburg infection warrant its
advancement to studies that may ultimately lead to the development
of the first effective therapeutic for this lethal infection," said
Leslie Hudson, Ph.D., President and Chief Executive Officer of AVI.
"We are excited by the potential shown by AVI's RNA therapeutics
for the treatment of infectious diseases including bioterrorism
agents such as Marburg and Ebola virus."
COL John P. Skvorak, Commander, USAMRIID, added, "There is a
significant need for the development of a therapeutic for Marburg
virus and the promising preclinical results demonstrated by
AVI-6003 support moving this candidate drug into clinical
development."
In repeated trials, monkeys were dosed with well-tolerated
amounts of drug and survived a challenge of roughly 1000 times the
minimum lethal dose of virus. This level of infectious challenge
normally results in uniform death of untreated monkeys within 7 to
10 days. Treatment of Marburg infected animals with AVI-6003
resulted in 100 percent survival at 15 days.
AVI-6003 is a novel analog based on AVI's PMO antisense
chemistry in which anti-viral potency is enhanced by the addition
of positively charged components to the morpholino oligomer
linkage.
AVI is conducting this research pursuant to the FDA's Animal
Efficacy Rule, which is designed for 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.
The majority of the collaborative research effort between AVI
and USAMRIID has been supported by a two year research contract
from the Department of Defense's Transformational Medical
Technologies Initiative with the goal of developing a new antiviral
(antisense) platform targeting hemorrhagic fever viruses. In
addition to development of antiviral agents for Marburg and Ebola,
AVI is receiving government funds to develop antiviral agents to
treat Jun�n virus under this contract. Under separate government
agreements, AVI is receiving support for programs in Dengue virus,
anthrax and ricin, as well as for additional applications in Ebola
and Marburg.
About Marburg 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. For more
information about Marburg virus, visit www.cdc.gov
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 is focused on the discovery and development of
RNA-based drugs utilizing proprietary derivatives of its antisense
chemistry (morpholino-modified phosphorodiamidate oligomers or
PMOs) that can be applied to a wide range of diseases and genetic
disorders through several distinct mechanisms of action. Unlike
other RNA therapeutic approaches, AVI's antisense technology has
been used to directly target both messenger RNA (mRNA) and its
precursor (pre-mRNA), allowing for both up- and down-regulation of
targeted genes and proteins. AVI's RNA-based drug programs are
being evaluated for the treatment of Duchenne muscular dystrophy as
well as for the treatment of cardiovascular restenosis through our
partner Global Therapeutics, a Cook Group Company. AVI's antiviral
programs have demonstrated promising outcomes in Ebola Zaire and
Marburg Musoke virus infections and may prove applicable to other
viral targets such as HCV or Dengue viruses. For more information,
visit 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.
AVI Press and Investor Contact: Julie Rathbun
investorrelations@avibio.com (541) 224-2575
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