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World's First Clinical Trial of Drug-Eluting Stent Using RNA Therapeutic Agent to Treat Coronary Artery Disease

Global Therapeutics, a leading developer of innovative solutions for the cardiology market, today 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, 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.”

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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