AVI BioPharma Partner Global Therapeutics Announces Positive Pre-Clinical Results Shown Using NEUGENE Antisense Drug in Preventi
July 25 2007 - 9:08AM
Business Wire
AVI BioPharma, Inc. (Nasdaq:AVII), today announced that its partner
Global Therapeutics, a Cook Medical company, indicated in a press
release today that results from animal studies using AVI�s NEUGENE�
antisense drug AVI-5126 to prevent cardiovascular restenosis were
�highly promising.� Global Therapeutics noted that the studies
showed successful safe delivery of a therapeutic dose of the
antisense agent to the specific site of stenting, with no systemic
adverse events. Joseph B. Horn, president of Global Therapeutics,
stated in the release that his company plans to initiate a human
clinical trial of the treatment in the near future, pending
regulatory approval. The study design will incorporate up to 20
investigational centers throughout Europe with the intent to
support a CE-mark filing. Horn indicated that Global Therapeutics
expects that AVI�s compound will be part of a kit that includes a
bare metal cobalt chromium stent, a subselective drug delivery
catheter and AVI-5126, which inhibits the c-myc gene. AVI has
previously shown in a Phase II clinical study that its drug
AVI�4126 (Resten-NG�), also targeting the c-myc gene, reduced the
rate of restenosis after balloon angioplasty and stent placement by
approximately 75 percent. AVI�5126 has the same NEUGENE antisense
component as Resten-NG, but also incorporates a peptide to enhance
delivery. According to an article in the Wall Street Journal on
July 20, 2007, which reviewed a survey by Goodroe Healthcare
Solutions LLC, doctors in the United States in June performed fewer
artery-inflating angioplasties and used about 4 percent fewer
stents than they did in January 2007. According to Goodroe, these
data suggest that recent medical studies critical of the devices
appear to be having an impact on their use. �We are encouraged by
our partner Global Therapeutics� initial success using our compound
to inhibit restenosis in these preclinical studies,� said K.
Michael Forrest, interim chief executive officer of AVI. �Given the
ongoing concern over the use of drug-eluting stents, we believe
this c-myc gene-targeting approach may provide a practical
alternative for the prevention of restenosis following angioplasty
or other invasive cardiovascular procedures.� AVI is currently
engaged in a Phase Ib/II clinical trial of AVI-5126 in patients
undergoing coronary artery bypass graft (CABG) procedures. This
potential 600 patient, multicenter, double-blind, randomized and
placebo-controlled trial is ongoing in Ukraine, with additional
centers expected to commence enrolling patients in Poland once
regulatory approval is obtained. The trial is expected to assess
the safety and effectiveness of an application of AVI-5126 ex-vivo
(outside the body) to saphenous veins following their harvest and
before grafting. Although CABG is considered to be effective in
restoring blood flow in the short term, 30 percent to 50 percent of
venous grafts eventually become blocked or otherwise fail after one
to three years. Patients will be managed similarly within the
trial, except for variations in the immersion solutions for the
veins. Graft failure will be assessed by quantitative coronary
angiography. C-myc is a key regulatory gene involved in
cardiovascular restenosis. AVI believes it regulates various
downstream genes that produce the pathology of restenosis, namely
cell migration and adhesion, collagen formation, secretion of
extra-cellular matrix, and cell proliferation, among others. Global
Therapeutics licenses AVI-5126 from AVI BioPharma for
cardiovascular restenosis, while AVI retains the rights to the
compound in CABG. 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 West Nile virus, hepatitis C virus, dengue
virus, Ebola virus and influenza A virus. AVI�s NEUGENE-based
ESPRIT technology will initially be 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. About
Cook Medical Cook Medical was the first company to introduce
interventional devices in the United States. Today, the company
integrates device design, biopharma, gene and cell therapy and
biotech to enhance patient safety and improve clinical outcomes in
the fields of aortic intervention; cardiology; critical care
medicine; gastroenterology; radiology, peripheral vascular, bone
access and oncology; surgery and soft tissue repair; urology; and
assisted reproductive technology, gynecology and high-risk
obstetrics. Cook won the prestigious Medical Device Manufacturer of
the Year Award for 2006 from Medical Device & Diagnostic
Industry magazine. For more information, visit www.cookmedical.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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