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news.AVI BioPharma, a developer of RNA-based drugs, has announced that its partner Global Therapeutics, a Cook Medical company, has initiated a clinical trial of a drug eluting stent that uses a 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.
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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 six months. Angiographic results will be reported at six months using quantitative coronary angioplasty and intravascular ultrasound.
The primary endpoint for the study is composite safety – major adverse cardiac events – 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.
Joseph Horn, president of Global Therapeutics, said: “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 groundbreaking trial that advances the science of treating coronary artery disease beyond what current technologies can achieve. With the help of our European colleagues, we eagerly anticipate a successful outcome to this landmark trial in 2009.”