AVI BioPharma Announces Initiation of Clinical Trial of Next Generation Drug Eluting Stent by Partner Global Therapeutics
November 10 2008 - 8:00AM
Marketwired
AVI BioPharma, Inc. (NASDAQ: AVII), a developer of RNA-based drugs,
today announced that its partner Global Therapeutics, a Cook
Medical company, has initiated the world's first clinical trial of
a drug eluting stent that uses a PPMO (peptide-conjugated
morpholino phosphorodiamidate oligomer)-based RNA therapeutic agent
aimed at silencing C-MYC, one of the genes responsible for causing
arteries to reclose after stenting (restenosis).
"The initiation of this first clinical trial of a drug eluting
stent utilizing our RNA-based therapeutic agent is a significant
milestone for AVI BioPharma and demonstrates a novel and promising
application of our new generation of translation-suppressing
oligomers," said Leslie Hudson, Ph.D., President and Chief
Executive Officer of AVI. "We look forward to the advancement of
this program and are excited by its potential to usher in a new
generation of drug eluting stents."
Global Therapeutics' GTX bare metal stent, which is already
marketed in Europe, is coated with AVI's latest generation
antisense compound coupled with a non-polymer, biodegradable
excipient to release the AVI compound after stent implantation. The
GTX cobalt chromium stent is designed for optimal ease of
deliverability, radial strength and clinical performance.
"Based on our preliminary work with this class of drug, the
delivery system, and the stent platform, we are extremely excited
to begin what we hope will be a ground-breaking trial that advances
the science of treating coronary artery disease beyond what current
technologies can achieve," explained Joseph B. Horn, president,
Global Therapeutics, a Cook Group company. "With the help of our
European colleagues, we eagerly anticipate a successful outcome to
this landmark trial in 2009."
The AVI drug used in the GTX DES device, AVI-5126, is an
enhanced antisense agent that targets a key regulatory gene
involved in cardiovascular restenosis, silencing the gene before
the biochemical events leading to restenosis can be triggered. The
enhanced antisense compound has increased potency and
bioavailability compared with its predecessors, allowing for a DES
system with less drug. Once implanted, the stent sheds its drug and
excipient coating, leaving behind a bare metal stent after 24
hours. The drug stays resident in the tissue for over two
weeks.
The feasibility study is a prospective, open label, multi-center
trial being performed in Germany. As many as 90 patients will be
enrolled and all subjects will undergo clinical follow-up at 30
days and 6 months. Angiographic results will be reported at 6
months using quantitative coronary angioplasty (QCA) and
intravascular ultrasound (IVUS). The primary endpoint for the study
is composite safety -- Major Adverse Cardiac Events (MACE) -- at 30
days. Other endpoints include performance criteria such as in-stent
and in-segment late loss, binary restenosis, and target lesion
revascularization. Data from the study will be compared to
historical controls of both bare and drug eluting stents.
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.
About Cook Medical
Cook Medical was one of the first companies to help popularize
interventional medicine, pioneering many of the devices now
commonly used worldwide to perform minimally invasive medical
procedures. Today, the company integrates minimally invasive
medical device design, biopharma, gene and cell therapy and biotech
to enhance patient safety and improve clinical outcomes in the
fields of aortic intervention; interventional 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. Founded in 1963 and operated as a family-held private
corporation, Cook is a past winner of the prestigious Medical
Device Manufacturer of the Year Award 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.
AVI Press and Investor Contact: Julie Rathbun Investor Relations
(541) 224-2575 Investorrelations@avibio.com
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