AVI BioPharma Announces Refocused Clinical Development Strategy
August 08 2007 - 4:00AM
Business Wire
AVI BioPharma, Inc. (Nasdaq:AVII), today announced a strategic
refocusing of its clinical pipeline and a reprioritization of its
programs. AVI will focus on advancing NEUGENE� product candidates
targeting cardiovascular and genetic diseases, optimizing compounds
targeting infectious diseases, and testing new technologies that
leverage the NEUGENE antisense platform, such as exon-skipping
pre-RNA interference technology (ESPRIT). �As announced in May, we
have evaluated the many potential treatment applications made
possible by the versatility of NEUGENE antisense and will focus our
internal resources on those that offer what we believe to be the
most viable near-term market opportunities,� said K. Michael
Forrest, interim chief executive officer of AVI. �We continue to be
impressed with the progress of our partner, Global Therapeutics (a
Cook Medical company), in developing NEUGENE compounds targeting
restenosis. We also expect to advance our own clinical programs in
the months ahead, including the ongoing NEUGENE trial in coronary
artery bypass graft (CABG) surgery and a new trial using our ESPRIT
technology in Duchenne muscular dystrophy (DMD).� NEUGENE Program
Update Restenosis: Cook Medical Global Therapeutics, which licensed
NEUGENE product candidates from AVI in March 2006 for use in
cardiovascular restenosis applications, recently completed a
six-month follow-up analysis of the Phase II APPRAISAL clinical
trial. APPRAISAL was designed to study the effects of AVI-4126, a
NEUGENE compound delivered systemically via microparticles, for the
prevention of cardiovascular restenosis when used in conjunction
with the placement of one or more bare-metal stents. Global
Therapeutics recently announced that data from the trial is
expected to be presented at the Transcatheter Cardiovascular
Therapeutics (TCT) conference in October 2007 and expressed its
desire to rapidly commercialize NEUGENE products for the cardiology
market, in a July 9, 2007, press release. On July 25, 2007, Global
Therapeutics also announced plans to conduct a clinical trial for
the inhibition of restenosis in patients following angioplasty
using a bare-metal cobalt chromium stent, a sub-selective drug
delivery catheter, and AVI-5126 � a combination of AVI-4126 and a
delivery peptide. The study, which Global Therapeutics plans to
begin in 2007 subject to regulatory approval, is designed to
incorporate up to 20 investigational centers throughout Europe with
the intent to support a CE-mark filing. Coronary Artery Bypass
Grafting (CABG) A priority within AVI�s cardiovascular program is
the company�s evaluation of AVI-5126 for use in CABG procedures.
The CABG trial involves ex vivo (outside the body) application of
AVI-5126 to the saphenous vein following harvest and before
grafting into the coronary artery. The goal of this study is to
determine if AVI-5126 reduces the incidence of graft re-blockage
following the procedure. No safety issues have been reported to
date in this double-blind, placebo-controlled trial for which
enrollment is ongoing. The trial is underway in the Ukraine, with
additional sites soon to come on line in Poland. Enrollment of the
first 110 patients for the 600-patient trial is expected by the
first quarter of 2008. Hepatitis C (HCV) As part of the pipeline
refocusing, AVI is discontinuing its planned dose-escalating HCV
trial using AVI-4065. Instead, AVI researchers will apply recent
innovations to HCV compounds with the goal of improving the
delivery to targeted cells, increasing potency and lowering overall
dosage requirements, potentially resulting in a more commercially
viable product. Other Infectious Diseases Other infectious disease
therapeutics remain an important facet of AVI�s research pipeline,
highlighted by the collaborative efforts ongoing at the U.S. Army
Medical Research Institute of Infectious Diseases (USAMRIID). These
preclinical efforts, the most advanced of which evaluate AVI
compounds against the Ebola virus, provide an opportunity to
demonstrate NEUGENE antisense in a high-containment setting
targeting potential bioterror threats. Knowledge gained in this
setting may be transferable to other viral and non-viral targets.
In addition, AVI is continuing its H5N1 avian influenza program for
the development of an agent targeting this potential pandemic
disease. ESPRIT Program Update ESPRIT technology holds potential as
a potent tool for altering many disease mechanisms. While
conventional antisense blocks protein production, ESPRIT compounds
induce cellular machinery to skip an exon. An exon is a packet of
genetic information used in part to build a protein. In some
diseases, a genetic mutation results in one or more exons being
deleted. When this occurs, a needed protein may be altered or not
produced at all. The ESPRIT mechanism provides a fine-tuned
approach to interfering with this disease process. Based upon
favorable preclinical results in Duchenne muscular dystrophy (DMD)
animal models, AVI has selected DMD as the first indication to
pursue using ESPRIT. Duchenne Muscular Dystrophy DMD is a
progressively debilitating and fatal disease caused by one or more
mutations in the gene that codes for dystrophin, a protein that is
crucial for muscle function. Most of the mutations cause subsequent
exons to be misread by the cell machinery so that no functional
dystrophin is produced. AVI�s objective is to use the ESPRIT
therapeutic AVI-4658 to skip exon 51, which would put the
subsequent protein back in the correct reading frame, creating a
shortened but functional version of dystrophin. Research teams at
the Imperial College London, U.K., are entering into a
proof-of-principle, controlled, dose-escalating trial using
AVI-4658. In the trial, up to nine boys with DMD will receive a
single intramuscular administration of the drug. Two to three weeks
following injection, the muscle will be biopsied and examined for
molecular evidence of dystrophin production. In parallel, AVI is
also aggressively pursuing expansion of a clinical development
program to include a multicenter, dose-ranging trial for systemic
administration of AVI-4658 for the treatment of DMD. This product
will be developed in conjunction with its cross-licensing and
development partner, Ercole Biotech. AVI intends to pursue
additional opportunities with the ESPRIT program. About AVI
BioPharma AVI BioPharma develops therapeutic products for the
treatment of life-threatening diseases using third-generation
NEUGENE antisense drugs and ESPRIT exon skipping technology. AVI�s
lead NEUGENE antisense compound is designed to target cell
proliferation disorders, including cardiovascular restenosis. In
addition to targeting specific genes in the body, AVI�s antiviral
program uses NEUGENE antisense compounds to combat disease by
targeting single-stranded RNA viruses, including dengue virus,
Ebola virus and H5N1 avian influenza virus. AVI�s NEUGENE-based
ESPRIT technology is initially being applied to potential
treatments for Duchenne muscular dystrophy. More information about
AVI is available on the company�s Web site at
http://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.
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