AVI BioPharma Awarded up to $291 Million U.S. Government Contract for Advanced Development of Therapeutic Candidates for Ebola a
21 July 2010 - 7:39AM
Marketwired
AVI BioPharma, Inc. (NASDAQ: AVII), a developer of RNA-based
therapeutics, announced that it has been awarded a new contract for
up to approximately $291 million total with the U.S. Department of
Defense Chemical and Biological Defense Program through the U.S.
Army Space and Missile Defense Command for the advanced development
of the Company's hemorrhagic fever virus therapeutic candidates,
AVI-6002 and AVI-6003, for Ebola and Marburg viruses, respectively.
The contract was awarded as part of the Transformational Medical
Technologies (TMT) program, which was created to develop innovative
platform-based solutions to counter biological threats. The
contract is the largest ever awarded under the TMT program.
"TMT has taken a leadership position in addressing infectious
and other biological threats and we appreciate their continuing
confidence in the unique capabilities of our proprietary RNA-based
platform technologies to efficiently and effectively address those
threats," said J. David Boyle II, AVI's interim President and Chief
Executive Officer, and Chief Financial Officer. "I view the award
of this contract as further recognition of the capabilities of the
AVI team. Additionally, it highlights the value of our proprietary
technologies, particularly our PMOplus™ chemistry, which we have
used successfully in programs targeting other viruses, including
Influenza, Dengue and Junín viruses. I look forward to aggressively
leveraging our technologies to discover and develop other
therapeutic candidates."
TMT is actively supporting both the development of
broad-spectrum medical countermeasures and innovative
platform-based technologies with broad applicability to a range of
biological threats. Of particular interest to TMT are adaptable
platforms capable of rapidly generating medical countermeasures.
Through two separate funded efforts with TMT, AVI's platform has
demonstrated the ability to rapidly generate medical
countermeasures against a broad range of biological threats.
Conference Call A conference call to
provide a business overview will be held tomorrow, Wednesday, July
21, 2010, at 11:00 a.m. Eastern time (8:00 a.m. Pacific time). J.
David Boyle II, AVI's Interim President and Chief Executive
Officer, and Chief Financial Officer, will host the call.
The conference call may be accessed by dialing 866.783.2142 for
domestic callers and 857.350.1601 for international callers. The
passcode for the call is 11298444. Please specify to the operator
that you would like to join the "AVI BioPharma business overview
call." The conference call will be webcast live under the events
section of AVI's website at www.avibio.com, and will be archived
there following the call. Please connect to AVI's website several
minutes prior to the start of the broadcast to ensure adequate time
for any software download that may be necessary.
About the Contract The contract is
structured into four segments. Activity under the first segment
provides for funding to AVI of up to approximately $80 million and
is to begin immediately. 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 was granted in response to proposals the Company
submitted to a Request for Proposal (RFP) issued in November 2009
and initially submitted by the Company in February 2010. Under an
earlier U.S. Department of Defense contract through the TMT
program, the Company completed development activities that
culminated in the opening of Investigational New Drug (IND)
applications for both AVI-6002 and AVI-6003.
About AVI-6002 and AVI-6003 AVI-6002 and
AVI-6003 are RNA-based therapeutic candidates from the Company's
anti-infective portfolio and use AVI's proprietary PMOplus™
chemistry. 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.
About Ebola and Marburg Hemorrhagic Fevers
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 fevers,
headache, muscle aches, 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.
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 the Transformational Medical Technologies
(TMT) Program The TMT program was created by the U.S.
Department of Defense to protect the Warfighter from emerging and
genetically altered biological threats by discovering and
developing a wide range of medical countermeasures through enhanced
medical research, development, test and evaluation programs. The
TMT Program Office is matrixed from the Joint Science and
Technology Office -- DTRA and Joint Program Executive Office --
Chemical and Biological Defense, with oversight from the Office of
the Secretary of Defense. For more information on TMT, visit
http://www.tmti-cbdefense.org.
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, we are able to target a broad range of
diseases and disorders through distinct RNA-based mechanisms of
action. Unlike other RNA-based approaches, our 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 our highly differentiated RNA antisense-based
technology platform, we have built a pipeline of potentially
transformative therapeutic agents, including a clinical stage
Duchenne muscular dystrophy candidate and anti-infective candidates
for influenza and hemorrhagic fever viruses. For more information,
visit www.avibio.com.
Forward-Looking Statements and Information
This press release contains statements that are forward-looking,
including statements about the amount and timing of potential
funding; the development of AVI 6002 and AVI 6003, including
preclinical development, filing of an IND application, completion
of a Phase 1 human safety clinical trial, clinical development and
FDA approval; AVI's PMOplus™ chemistry and other antisense-based
technology and its ability to protect against Ebola and Marburg
virus, as well as its efficacy, potency and utility in the
treatment of infectious diseases, and its potential to treat other
disease indications. These forward-looking statements involve risks
and uncertainties, many of which are beyond AVI's control. Known
risk factors include, among others: development of either or both
of AVI 6002 and/or AVI 6003 may not result in funding from the TMT
in the anticipated amounts or on a timely basis, if at all;
clinical trials may not demonstrate safety and efficacy of any of
AVI's drug candidates and/or our antisense-based technology
platform; 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 its common stock. For a
detailed description of risks and uncertainties we face, 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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