November 11, 2008 - Global Therapeutics today initiated 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).
The company said it hopes the ground-breaking technology advances the science of treating coronary artery disease beyond what current technologies can achieve. Trial results are expected 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 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. The stent uses rounded off the edges to minimize the potential for vessel injury.
The drug used in the GTX DES device, AVI-5126, was developed by AVI BioPharma and is 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 more than two weeks, the company said.
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 six 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.
For more information: www.cookmedical.com, www.avibio.com