AVI BioPharma, Inc. Presents Update on AVI-4658 at TREAT-NMD / NIH International Conference
November 19 2009 - 8:00AM
Marketwired
AVI BioPharma, Inc. (NASDAQ: AVII), a developer of RNA-based drugs,
today announced presentations on the company's exon skipping
therapy for Duchenne muscular dystrophy at the TREAT-NMD / NIH
International Conference taking place Nov. 17-19 in Brussels,
Belgium.
At the conference, data from the company's clinical and
preclinical programs were presented. An update on the company's
ongoing systemic Phase 1b/2 trial of AVI-4658 was provided by
Professor Francesco Muntoni, of the MDEX consortium in the UK,
during an oral presentation and also summarized in a poster
presentation. The most recent data from the ongoing Phase 1b/2
trial at two MDEX sites in the UK demonstrate that AVI-4658 was
well tolerated by DMD patients in a dose escalation study that is
now up to the sixth and final cohort (20 mg/kg). The maximum
cumulative dose administered to date is 3132 mg and the maximum
single dose is 900 mg with no adverse safety signals, in either
case.
A series of posters were also presented by Peter Sazani, Ph.D.,
Executive Director of Preclinical Development. Data presented
included preclinical findings demonstrating that treatment with
AVI-4658 was tolerated at dosages up to 960 mg/kg in mice and up to
320/mg/kg in primates -- both maximum feasible doses.
The aim of the TREAT-NMD Conference is to share progress in the
area of translational medicine in inherited neuromuscular diseases
and to set the future collaborative agenda.
The open label dose-finding clinical trial of AVI-4658 is
evaluating the systemic delivery of AVI-4658 once per week for
12-weeks by intravenous infusion. It is being conducted in London,
UK at the UCL Institute of Child Health / Great Ormond Street
Hospital NHS Trust facilities by members of the MDEX Consortium led
by Professor Muntoni and by Professor Kate Bushby 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.
About TREAT-NMD
TREAT-NMD is a Network of Excellence facilitating collaborative
research in neuromuscular disease that aims to create the
infrastructure to ensure that the most promising new therapies
reach patients as quickly as possible. Since the network was
launched in January 2007 it has built up the tools that industry
and researchers need to bring promising new therapies more quickly
from the lab to the clinic. One of the key TREAT-NMD
infrastructures built up in the last two years is a global patient
registry for DMD and SMA comprising more than 30 national patient
registries worldwide. The DMD registries now hold more than 10,000
individual patient entries with standardized items and patient
consent, facilitating and accelerating clinical research and trials
while giving patients improved access to relevant information on
standards of diagnosis and care. These registries have been set up
in collaboration with clinicians and patient organizations across
the world and contain the key information needed to establish
whether a particular patient might be eligible for a trial,
together with the means of contacting them. Registries for other
conditions are also in preparation. For more information, please
visit www.treat-nmd.eu.
About the MDEX Consortium
The MDEX consortium led by Professor Muntoni, is a
mutlidisciplinary enterprise to promote translational research into
muscular dystrophies, and is formed by the clinical groups of
Professor Francesco Muntoni (Imperial College London and UCL
Institute of Child Health) and Professor Kate Bushby and Professor
Volker Straub (Newcastle University), and scientists from Imperial
College London (Professor Dominic Wells), UCL Institute of Child
Health (Dr Jennifer Morgan), Royal Holloway University of London
(Professor George Dickson and Dr Ian Graham), Oxford University (Dr
Matthew Wood) and University of Western Australia (Prof Steve
Wilton). In addition, the charities Muscular Dystrophy Campaign
(MDC), Action Duchenne and Duchenne Family Support Group also
participate in the Consortium. For more information visit
www.mdex.org.uk.
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 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
Junin, 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.
AVI Press and Investor Contact: Julie Rathbun Investor Relations
(541) 224-2575 Investorrelations@avibio.com
Avi Biopharma (NASDAQ:AVII)
Historical Stock Chart
From May 2024 to Jun 2024
Avi Biopharma (NASDAQ:AVII)
Historical Stock Chart
From Jun 2023 to Jun 2024