AVI BioPharma to Present Safety Update From Ongoing Systemic Trial of AVI-4658 at 7th Annual Action Duchenne International Confe
October 22 2009 - 8:00AM
Marketwired
AVI BioPharma, Inc. (NASDAQ: AVII), a developer of RNA-based drugs,
today announced that it will present updated preliminary safety
data from its ongoing systemic Phase 1b/2 clinical trial of
AVI-4658 in patients with Duchenne muscular dystrophy (DMD) at the
7th Annual Action Duchenne Conference taking place Oct. 23-24 in
London, UK.
Steve Shrewsbury, M.D., Chief Medical Officer and Senior Vice
President of Preclinical, Clinical and Regulatory Affairs of AVI,
will present during a session, "Medicines for Duchenne: AVI-4658
Clinical Trials," on Saturday, Oct. 24 at 2:30 p.m. local time.
Previously announced results from the ongoing Phase 1b/2
systemic trial have demonstrated that AVI-4658 has been well
tolerated in patients with DMD in the first two completed cohorts
(0.5 mg/kg and 1.0 mg/kg) and two ongoing cohorts (2.0 mg/kg and
4.0 mg/kg). There have been no drug-related safety issues
identified. Data to be presented at the conference will include
updated safety information from the four patients being dosed in
the penultimate dose cohort (10 mg/kg). In each cohort, including
the final cohort of 20 mg/kg, data for the clinical effects of the
treatment will be collected for 26 weeks from first dose.
The open label dose-finding clinical trial is evaluating the
systemic delivery of AVI-4658 once per week for 12-weeks by slow
intra-venous infusion. Although the study is primarily a safety
trial, it includes measures of drug efficacy and pharmacokinetics
and is being conducted in London, UK at the UCL Institute of Child
Health / Great Ormond Street Hospital NHS Trust facilities and at
the Royal Victoria Infirmary, Newcastle-Upon-Tyne, UK, which is the
coordinating center for the European Treat Neuromuscular Diseases
(Treat-NMD) initiative. The clinical costs for the trial are
provided, in part, by the UK Medical Research Council.
Data from the completed single-blind, placebo-controlled and
dose escalation Phase 1 trial showed that AVI-4658 was safe when
injected intramuscularly and successfully induced the production of
dystrophin protein in patients in a dose-responsive manner.
About Duchenne Muscular Dystrophy (DMD)
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 Duchenne Muscular Dystrophy 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 as
well as for the treatment of cardiovascular restenosis through our
partner Global Therapeutics, a Cook Group Company. 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 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.
AVI Press and Investor Contact: Julie Rathbun Investor Relations
(541) 224-2575 Investorrelations@avibio.com
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