AVI BioPharma, Inc. (NASDAQ: AVII), a developer of RNA-based
therapeutics, today announced the presentation of data from the
Company's infectious disease programs at the 22nd Annual European
Congress of Clinical Microbiology and Infectious Diseases (ECCMID)
taking place in London, United Kingdom from March 31 to April 3.
These programs utilize a common platform -- AVI's patented PMOplus®
technology.
Alison Heald, M.D., Senior Director of Clinical Development at
AVI, will present two posters during Session I, titled "A Phase I,
Single Ascending-Dose Study of AVI-6002, a Combination of Two
PMOplus® Compounds with Activity Against Ebola Virus" and "A Phase
I, Single Ascending-Dose Study of AVI-6003, a Combination of Two
PMOplus® Compounds With Activity Against Marburg Virus." Both
presentations will be given during the session called "Virology
Non-HIV/Non-Hepatitis" and are scheduled at 3:30 p.m. GMT on
Saturday, March 31. The presentations will feature data from the
single ascending dose studies of AVI's Ebola therapeutic, AVI-6002,
and Marburg therapeutic, AVI-6003. These studies exhibited positive
safety results for each therapeutic candidate in all six dose
cohorts, up to a maximum dose of 9 mg/kg.
Pat Iversen, Ph.D., Senior Vice President of Research and
Innovation at AVI, will present a poster during Session I titled
"No Mutations Detected With PMOplus® Antisense Oligomers That
Protect Nonhuman Primates Against Marburg Virus" at 3:30 p.m. GMT
on Saturday, March 31. The poster, which will be given during the
session called "Virology - Diagnosis, Epidemiology, Prophylaxis and
Therapy," will feature data from animal studies of AVI's lead
Marburg therapeutic, AVI-6003, in Marburg infected nonhuman primate
models. These preclinical studies, as well as those of AVI-6002,
have been a collaborative effort between AVI and scientists at the
U.S. Army Medical Research Institute of Infectious Diseases
(USAMRIID), which has the DOD's only maximum containment, or
Biosafety Level 4, capability.
AVI is conducting the work presented in the three previously
mentioned posters 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).
Dr. Iversen will also present two posters featuring data from
preclinical studies of AVI's lead influenza therapeutic, AVI-7100,
during Session I at 3:30 p.m. GMT on Saturday, March 31. The poster
titled "Post Exposure Efficacy of AVI-7100 Against Influenza A in
Mouse and Ferret Infection Models" will be given during the session
called "Molecular Virology," while the poster titled "Prophylactic
Efficacy of AVI-7100 Against Influenza A in Mouse and Ferret
Infection Models" will be given during the session called "Virology
- Diagnosis, Epidemiology, Prophylaxis and Therapy." Together, the
data demonstrate both post exposure and prophylactic efficacy of
AVI-7100 in influenza virus-infected mouse and ferret models.
AVI-7100 was preclinically developed and identified with support
from JPM-TMT.
Finally, Dr. Iversen will present a poster during Session III
titled "Peptide Phosphorodiamidate Morpholino Oligomers as
Gene-Silencing Antisense Therapeutics for Mycobacterium
Tuberculosis" at 1:30 p.m. GMT on Sunday, April 1. The
presentation, which will be given during the session called "New
Antimicrobial Agents Against Old and New Protein Targets," will
feature data demonstrating efficacy of AVI's platform chemistry in
Mycobacterium tuberculosis in cell culture studies as part of AVI's
program on extensively drug-resistant tuberculosis (XDR-TB). AVI is
pursuing this program in collaboration with leading scientists at
the Swedish medical university Karolinska Institutet to identify
RNA-based therapeutic candidates for the treatment of XDR-TB.
About Ebola and Marburg Viruses The
hemorrhagic fever caused by the Ebola virus is severe and often
fatal 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 with symptoms
that 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 and the mortality rate is very
high.
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. 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 and the
mortality rate is even higher than that of Ebola infection.
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 the addition of
selectively introduced positive charges to the PMO's inherently
charge-neutral backbone. PMOplus® is believed to have potentially
broad therapeutic applications and has thus far shown to be
particularly effective in increasing the potency of PMO-based
oligomers.
About JPM-TMT The Joint Project Manager
Transformational Medical Technologies (JPM-TMT) Project Management
Office, 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 Karolinska Institutet Karolinska
Institutet is one of the world's leading medical universities. Its
mission is to contribute to the improvement of human health through
research and education. Karolinska Institutet accounts for over 40
percent of the medical academic research conducted in Sweden and
offers the country's broadest range of education in medicine and
health sciences. Since 1901 the Nobel Assembly at Karolinska
Institutet has selected the Nobel laureates in Physiology or
Medicine. For more information, visit ki.se.
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 and the efficacy, potency and utility of AVI's
product candidates in the treatment of rare and infectious
diseases.
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; 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 858.717.2310 or
212.845.4271 Email Contact
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