A Phase 1b Study Evaluating RESTEN-MP in Subjects With Focal de Novo Stenosis
Status:
Terminated
Trial end date:
1969-12-31
Target enrollment:
Participant gender:
Summary
The process of re-narrowing of a coronary artery following a revascularization procedure such
as angioplasty, begins at the time of the procedure. Restenosis has long been considered a
major problem for effective long-term interventional success. This often results in repeated
procedures to deal with recurrent stenosis (or restenosis) of the original targeted vessel.
There is a substantial body of literature suggesting that local MYC protein production in the
injured coronary artery is a major stimulus and potential cause of restenosis that appears
after stent placement. This study is based upon the hypothesis that stopping MYC protein
production in the vessel has will help reduce restenosis (vessel re-narrowing).
AVI BioPharma Inc., has utilized its proprietary antisense chemistry to design a drug that
interferes with MYC production.
This study will evaluate the safety, pharmacokinetics and potential effectiveness of a single
intravenous slow-push dose of RESTEN-MP at the time of stent placement to reduce in-stent
restenosis following balloon angioplasty and stent placement. The post-dose follow-up period
is up to six-months.