NeuGene® Clinical Development Overview
Initial applications for NeuGene antisense compounds include use in drug metabolism and in treating cardiovascular disease, cancer, polycystic kidney disease, and viral diseases. AVI currently has NeuGene compounds at various stages of clinical development as summarized in the table below.
| Preclinical | Phase I/Ib | Phase II | Phase III | |
|---|---|---|---|---|
| Resten-NG for Restenosis |
Completed | Completed | Completed | Planned |
| Resten-MP IV for Restenosis |
Completed | Completed | Completed | |
| AVI-5126 for CABG |
Completed | In Progress | In Progress | |
| AVI-4065 for Hepatitis C |
Completed | Completed | ||
| AVI-6001 for Influenza/Avian Flu |
In Progress | Planned | ||
| AVI-6002 for Ebola virus |
In Progress | Planned | ||
| AVI-4557 for Drug Metabolism |
Completed | Completed | ||
| AVI-4658 for Muscular Dystrophy |
Completed | In Progress |
Completed
In Progress
Planned
During the past three years, AVI has completed eleven clinical trials using NeuGene antisense compounds. Conclusions from these studies are summarized below:
- No drug-related adverse events found after treating more than 250 patients
- Multiple delivery strategies evaluated: intravenous (IV), subcutaneous, intracoronary (IC) catheter, oral
- Phase II primary endpoints met in both cardiovascular restenosis and drug metabolism