The study is designed to evaluate Resten-MP delivered intravenously via microparticle technology, in conjunction with placement of one or more bare-metal stents. Resten-MP is a treatment designed to prevent restenosis, a narrowing of the coronary artery.
“We have demonstrated that our microparticle delivery system for Resten-MP is effective at delivering therapeutic concentrations of the drug to the sites of vessel injury,” said Patrick Iversen, senior vice president of R&D at AVI.
The drug component in Resten-MP, AVI-4126 (Resten-NG), was found to reduce restenosis in a phase II clinical trial. In that study, Resten-NG was injected directly into the coronary artery using a special drug delivery catheter at the time of stent placement. Resten-NG in the therapeutic dose arm demonstrated statistically significant efficacy in preventing restenosis. Further, Resten-NG significantly reduced the neointimal growth that contributes to the failure of angioplasty intervention. The binary restenosis rate was reduced by 75% among patients who received a therapeutic dose.
AVI-4126 is a third-generation antisense agent that targets the key regulatory gene involved in cardiovascular restenosis, the transcription factor referred to as c-myc.