AVI BioPharma GLP Safety Pharmacology and Genotoxicity Evaluations of AVI-4658 for Duchenne Muscular Dystrophy Published in the
February 04 2010 - 8:00AM
Marketwired
AVI BioPharma, Inc. (NASDAQ: AVII), a developer 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.
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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.
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