Global Therapeutics initiates trial of stent with RNA therapeutic
agent to prevent artery closure
November 2008
Global Therapeutics has announced initiation of the
world’s first clinical trial of a drug eluting stent that
uses an antisense RNA therapeutics agent aimed at silencing
one of the genes (c-myc) responsible for causing arteries to
reclose after stenting (restenosis).
“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.”
Global Therapeutics’ GTX bare metal stent, which already has CE Mark
approval for sale in Europe, will be coated with the latest generation
antisense compound from AVI BioPharma (NASDAQ:AVII) coupled with a
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. Horn added,
“One of the important features is that we have rounded off the edges of
our stent to minimize the potential for vessel injury. We designed this
stent as a hybrid with features from coil stents (round edges) and the
radial strength of a slotted tube.”
“Having our partner initiate this clinical study of a DES 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,
PhD, 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.”
The drug used in the GTX DES device, AVI-5126, was developed by AVI
BioPharma, Inc. and licensed by Cook Group. It is an enhanced antisense
agent that targets a key regulatory gene involved in cardiovascular
restenosis, silencing the gene before the restenosis cascade effect can
be triggered.
The enhanced antisense compound has increased potency compared with
its predecessors, allowing for a DES system with less drug and excipient.
Once implanted, the stent sheds its drug and excipient coating, leaving
behind a bare metal stent after 24 hours. Importantly, the drug stays
resident in the tissue for over two weeks, Horn explained.
The feasibility study is a prospective, open label, multi-center
study being performed in Germany. As many as 90 patients will be
enrolled in the study. All subjects will undergo clinical follow-up at
30 days and 6 months. Angiographic results will be reported at six
months using quantitative coronary angioplasty (QCA) and intravascular
ultrasound (IVUS).
The primary endpoint for the study is composite safety (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.
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