BOTHELL, WA--(Marketwire - October 22, 2009) - 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.
