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 Marketwire
BOTHELL, WA--(Marketwire - February 4, 2010) -AVI BioPharma, Inc. (NASDAQ: AVII), a
eveloper
of RNA-based drugs, today announced that the results and scientific
findings of Good Laboratory Practice (GLP)-compliant safety pharmacology
and genotoxicity evaluations of AVI-4658, a drug candidate being developed
by AVI for the treatment of Duchenne Muscular Dystrophy (DMD), were
published online in the International Journal of Toxicology. The
publication, "Safety Pharmacology and Genotoxicity Evaluation of AVI-4658,"
reports that the GLP-compliant preclinical studies revealed no study
related effects on health status, even when dosed at the maximum feasible
dose, and there were no reports of injection site reactions. It was also
reported that the genotoxicity evaluation of AVI-4658 revealed no genotoxic
potential, even at very high concentrations. These results suggest AVI-4658
may have a wide therapeutic window for chronic dosing and supported the
initiation of the Phase 1b/2 clinical trial of AVI-4658 that is ongoing in
the United Kingdom.
About Duchenne Muscular Dystrophy
DMD is one of the most common fatal genetic disorders to affect children
around the world. Approximately one in every 3,500 boys worldwide is
afflicted with DMD with 20,000 new cases reported each year. It is a
devastating and incurable muscle-wasting disease associated with specific
inborn errors in the gene that codes for dystrophin, a protein that plays a
key structural role in muscle fiber function. Symptoms usually appear in
male children by age three. Progressive muscle weakness of the legs and
pelvis eventually spreads to the arms, neck, and other areas. By age 10,
braces may be required for walking, and most patients are confined to a
wheelchair by age 12. Eventually, this progresses to complete paralysis and
increasing difficulty in breathing requiring ventilatory support. The
condition is terminal and death usually occurs before the age of 30. The
outpatient cost of care for a non-ambulatory DMD boy is among the highest
of any disease. There is currently no cure for DMD, but for the first time
ever, there are promising therapies in or moving into development.
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,
including an ongoing systemic Phase 1b/2 clinical trial of exon skipping
with AVI-4658. 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 Junín, influenza, 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. BiomedReports is not paid or compensated to report news and developments about publicly traded companies. Full disclosure can be read at the bottom of / About Us / Section
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