AVI BioPharma, Inc. (NASDAQ: AVII), a developer of RNA-based
therapeutics, today announced that it has received approval from
the Food and Drug Administration (FDA) to proceed with a single
oligomer, AVI-7288, in studies in both humans and non-human
primates to support the safety and efficacy of post-exposure
prophylaxis against Marburg virus infection. AVI-7288 is one of two
components that make up AVI-6003. Studies conducted to date have
shown that efficacy in non-human primates can be attributed to this
single component, while the second component, AVI-7287, does not
appear to contribute to efficacy. AVI is conducting this work under
a Department of Defense contract managed by the Joint Project
Manager Transformational Medical Technologies (JPM-TMT) Project
Management Office, a component of the Joint Program Executive
Office for Chemical and Biological Defense (JPEO-CBD). The FDA
approved proceeding with the Marburg program using the single
oligomer AVI-7288 under the original IND.
"While we have not seen any toxicity in humans to date with
AVI-6003, by removing AVI-7287 we have a simpler development path
and may improve the therapeutic window by evaluating a single
action agent," said Chris Garabedian, president and CEO of AVI
BioPharma. "We are pleased to be able to explore this single
oligomer as a potentially safe and effective treatment against this
lethal hemorrhagic fever virus."
AVI will proceed with dosing AVI-7288 in the Phase I multiple
ascending dose studies planned to characterize the safety,
tolerability and pharmacokinetics of multiple doses of the drug in
healthy adult volunteers. The randomized, double-blind placebo
controlled study will be overseen by a DSMB, who will review safety
and clinical laboratory data after each dose cohort prior to
enrolling the next highest dose cohort. AVI will also proceed using
AVI-7288 in non-human primate studies to continue to evaluate
efficacy.
Patrick Iversen, Ph.D., Senior Vice President of Research and
Innovation at AVI, will present the results of a non-human primate
confirmatory study conducted to evaluate the optimal dose and
components of AVI-6003 during the upcoming Association of
Microbiology BioDefense and Emerging Diseases Research Meeting in
Washington, DC. In the confirmatory study at higher doses of
PMOplus® at 15 mg/kg/component, survival was 90%, 100% and 0% in
the AVI-6003, AVI-7288 and placebo groups, respectively. Based on
these results, AVI concluded that AVI-7288 is the active component
in AVI-6003 and that further development would proceed accordingly
with the single oligomer component AVI-7288. The presentation is
titled "A Single PMOplus® Oligomer is Effective in a Cynomolgus
Macaque Marburg Virus Lethal Challenge Model" and will be presented
at 3:20 p.m. EST on Tuesday, February 28, 2012, during session
020/Therapeutics.
Dr. Iversen will also deliver a poster presentation titled
"Restoring Antibiotic Sensitivity with Antisense Inhibitors of Gene
Expression" at 1:00 p.m. EST on Tuesday, February 28, 2012, during
poster session 018.
The presentation and poster will be posted on the AVI BioPharma
website in the "Events & Presentations" section after the
respective sessions are completed. The presentation and poster will
be archived there following the presentation for 90 days.
AVI-7288 is a single oligomer, one of two composing AVI-6003.
AVI-7288 employs AVI's patented PMOplus® technology that
selectively introduces positive charges to its phosphorodiamidate
morpholino oligomer (PMO) backbone to improve interaction between
the drug and its target.
AVI-6003 has been AVI's lead therapeutic candidate to-date for
the Marburg virus and is a combination of AVI-7287 and AVI-7288,
both of which employ AVI's patented PMOplus® technology.
About Marburg Viruses Marburg hemorrhagic
fever is a severe and potentially fatal disease in humans first
recognized in 1967. It is caused by an RNA virus of the Filoviridae
family and is understood to be endemic to Africa. The Marburg virus
is classified as a Category A bioterrorism agent by the Centers for
Disease Control and Prevention, or CDC, and was determined to pose
a material threat to national security and public health by the
Secretary of Homeland Security in 2006. 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 dysfunctions.
There are currently no treatments for Marburg virus infection
beyond supportive care.
About AVI's PMOplus® Chemistry PMOplus®
chemistry is an advanced generation of AVI's phosphorodiamidate
morpholino oligomer, or PMO, technology pioneered by AVI. The PMO
platform is designed to provide a stable chemistry backbone with
superior drug-like characteristics for AVI's advanced RNA-based
therapeutics. PMOplus® chemistry includes specific molecular
charges positionally inserted into the PMO's inherent
charge-neutral backbone. PMOplus® has potentially broad therapeutic
applications and has thus far shown to be particularly effective in
increasing the potency of PMO-based oligomers.
About JPM-TMT JPM-TMT, an organization
within the Joint Program Executive Office for Chemical and
Biological Defense (JPEO-CBD) aims to protect the Warfighter from
emerging infectious diseases, genetically altered and unknown
biological threats. Through strategic investments and partnerships
with innovative biotech firms, pharmaceutical corporations, other
government agencies, and academic institutions, JPM-TMT facilitates
the advanced development and acquisition of broad-spectrum medical
countermeasures and systems to enhance our nation's biodefense
response capability. For more information, visit
www.jpmtmt.mil.
About USAMRIID U.S. Army Medical Research
Institute of Infectious Diseases (USAMRIID), located at Fort
Detrick, Maryland, is the lead medical research laboratory for the
U.S. Department of Defense's 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 novel RNA-based
therapeutics for rare and infectious diseases, as well as other
select disease targets. Applying pioneering technologies developed
and optimized by AVI, the Company is able to target a broad range
of diseases and disorders through distinct RNA-based mechanisms of
action. Unlike other RNA-based approaches, AVI's 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 its highly differentiated RNA-based technology
platform, AVI has built a pipeline of potentially transformative
therapeutic agents, including eteplirsen, which is in clinical
development for the treatment of Duchenne muscular dystrophy, and
multiple drug candidates that are in clinical development for the
treatment of infectious disease. For more information, please visit
www.avibio.com.
Forward-Looking Statements and
Information
In order to provide AVI's investors with an understanding of its
current results and future prospects, this press release contains
statements that are forward-looking. Any statements contained in
this press release that are not statements of historical fact may
be deemed to be forward-looking statements. Words such as
"believes," "anticipates," "plans," "expects," "will," "intends,"
"potential," "possible" and similar expressions are intended to
identify forward-looking statements. These forward-looking
statements include statements about the development of AVI's
product candidates, their efficacy, potency and utility in the
treatment of rare and infectious diseases, their potential to treat
a broad number of human diseases and AVI's plans to initiate Phase
I multiple ascending dose studies and non-human primate studies of
AVI-7288.
These forward-looking statements involve risks and
uncertainties, many of which are beyond AVI's control. Known risk
factors include, among others: clinical trials may not demonstrate
safety and efficacy of any of AVI's drug candidates and/or AVI's
antisense-based technology platform; development of AVI-7288 may
not result in funding from JPM-TMT in the anticipated amounts or on
a timely basis, if at all; and 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 AVI's common stock. For a detailed description of risks and
uncertainties AVI faces, 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.
AVI Media and Investor Contact: Erin Cox 425.354.5140 Email
Contact AVI Media Contact: David Schull 212.845.4271 Email
Contact
Avi Biopharma (NASDAQ:AVII)
Gráfica de Acción Histórica
De May 2024 a Jun 2024
Avi Biopharma (NASDAQ:AVII)
Gráfica de Acción Histórica
De Jun 2023 a Jun 2024