AVANIR's Investigational Anthrax Antibody Effective in Recognized Animal Model; UTMB Scientists Present Data at ASM Meeting
06 Junho 2005 - 2:11PM
Business Wire
Data presented today at the 105th General Meeting of the American
Society for Microbiology (ASM) described activity of AVANIR
Pharmaceuticals' (AMEX:AVN) fully human monoclonal antibody
treatment against inhalation anthrax. The data demonstrates that
one dose (lowest dose tested was 1 mg/kg) of AVANIR's antibody, AVP
21D9, completely protected rabbits challenged with 100xLD50 dose of
B. anthracis administered nasally. All animals, re-challenged three
weeks later with anthrax but without additional antibody treatment,
survived re-challenge as well. The data also showed that AVP 21D9
worked synergistically with the antibiotic Ciprofloxacin to protect
mice and guinea pigs. Johnny W. Peterson, Ph.D. of the University
of Texas Medical Branch (UTMB) presented the results in a poster
entitled "Human Monoclonal Anti-PA Antibody Completely Protects
Rabbits and is Synergistic with Ciprofloxacin in Protecting Mice
and Guinea Pigs Against Inhalation Anthrax" at the ASM meeting
being held this week in Atlanta, Georgia. "These data demonstrate
that AVANIR's anti-PA human monoclonal antibody is very effective
in protecting rabbits against anthrax spore challenge." said Dr.
Peterson. "The rabbit model is one of the recognized models for
determining efficacy of anti-anthrax antibodies. These data
indicate that AVP 21D9 may provide the necessary immediate
protection following anthrax exposure." AVP 21D9 is a human
monoclonal antibody to Bacillus anthracis protective antigen (PA)
that was discovered and developed by AVANIR Pharmaceuticals. AVP
21D9 has demonstrated efficacy in protecting against anthrax in
multiple experimental animal models. One molecule of the antibody
is capable of neutralizing two anthrax toxin molecules in rat
models. AVP 21D9 is the first antibody to demonstrate potency
against a toxin at this "sub-stoichiometric" level. "AVANIR's human
monoclonal antibodies to PA have high specificity and very
desirable binding properties, and offer considerable promise for
the rapid development of products useful as therapy against the
most lethal form of anthrax, inhalation anthrax," concluded Dr.
Peterson. The in vivo tests on passive immunization with AVANIR
human monoclonal antibodies are being conducted in small animal
models established at the University of Texas Medical Branch in
Galveston under contract from the National Institute of Allergy and
Infectious Disease (NIAID), a part of the National Institutes of
Health. Antibodies that neutralize anthrax toxins may augment
existing treatment options. Currently, a vaccine and antibiotics
are the treatment options available for the prevention or treatment
of anthrax exposure. Both approaches have limitations. The current
anthrax vaccine takes weeks following the first dose before
immunity is established, and requires multiple injections over a
period of months, in addition to annual boosters, to reach and
maintain its protective effect. Antibiotics, the standard treatment
of anthrax infection, are effective in killing anthrax bacteria,
but have no effect on the anthrax toxins and require extended
treatment for at least two months of twice daily dosing. AVANIR
Pharmaceuticals is a pharmaceutical company focused on developing
and commercializing novel therapeutic products for the treatment of
chronic diseases. AVANIR's product candidates address therapeutic
markets that include central nervous system and cardiovascular
disorders, inflammation, and infectious disease. AVANIR expects to
submit the final module of its rolling new drug application to the
U.S. Food and Drug Administration for its lead product candidate,
Neurodex(TM), in mid-2005. Recently, AVANIR partnered its
preclinical research and development program for inflammatory
disease with Novartis. The Company's first commercialized product,
Abreva(R), is marketed in North America by GlaxoSmithKline Consumer
Healthcare and is the leading over-the-counter product for the
treatment of cold sores. Further information about AVANIR can be
found at www.avanir.com. Except for the historical information
presented herein, matters discussed in this press release contain
forward-looking statements that are subject to certain risks and
uncertainties that could cause actual results to differ materially
from any future results, performance or achievements expressed or
implied by such statements. Statements that are not historical
facts, including statements that are preceded by, followed by, or
that include such words as "estimate," "anticipate," "believe,"
"plan" or "expect" or similar statements are forward-looking
statements. Risks and uncertainties for AVANIR Pharmaceuticals
include risks associated with product discovery and development,
our dependence on government grants to subsidize the development of
our anthrax antibodies, as well as risks shown in AVANIR's most
recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q
and from time-to-time in other publicly available information
regarding the company. Copies of such information are available
from AVANIR upon request. Such publicly available information sets
forth many risks and uncertainties related to AVANIR's business and
technology. Avanir's monoclonal antibody technology competes with
several technologies used by large pharmaceutical and biotechnology
companies and is subject to a number of uncertainties, including
risks associated with the success of clinical trials, the progress
of research and product development programs, the regulatory
approval process, competitive products, future capital requirements
and commercialization risks, particularly with drug candidates
being developed for the U.S. federal government. There can be no
assurance that such development efforts will succeed, that such
products will receive required regulatory clearance, or that even
if such regulatory clearance were received, that such products
would ultimately achieve commercial success. The company disclaims
any intent or obligations to update these forward-looking
statements.
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