Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Ad2/HIF-1α/VP16 · 1 trial · 3 indications
| Arm | Type | Description |
|---|---|---|
| Low Dose | ACTIVE_COMPARATOR | 2 x 10\^9 vp (viral particles) |
| Middle Dose | ACTIVE_COMPARATOR | 2 x 10\^10 vp |
| High Dose | ACTIVE_COMPARATOR | 2 x 10\^11 vp |
| Placebo | PLACEBO_COMPARATOR | (PBS + 10% sucrose + 0.02% polysorbate 80) |
| Name | Type | Description |
|---|---|---|
| Ad2/HIF-1α/VP16 | BIOLOGICAL | a one time treatment of 20 IM injections of 0.01 ML each into each leg for a total of 40 injections |
| Saline (Placebo Control) | OTHER | a one time treatment of 20 IM injections of 0.01 ML each into each leg for a total of 40 injections. |
Inclusion Criteria: * Males and females 40 to 80 years of age, inclusive. * Clinical diagnosis of PAD, secondary to atherosclerosis, in both lower limbs, confirmed by objective evidence: An ankle-brachial index (ABI) of ≤ 0.90 at rest in at least 1 lower limb (Note: The index limb must be ≤ 0.90 at...
Ad2/HIF-1α/VP16 is an investigational gene therapy being studied for the treatment of intermittent claudication, a condition associated with peripheral vascular disease and atherosclerosis. It is currently in Phase 2 clinical development and has not been approved by regulatory authorities.
Ad2/HIF-1α/VP16 is being developed by Sanofi, a multinational pharmaceutical company listed on the stock exchange under the ticker symbol SNY. The drug is in Phase 2 clinical trials for intermittent claudication.
Ad2/HIF-1α/VP16 is in Phase 2 clinical development. It is an investigational drug and has not received regulatory approval. A Phase 2 clinical trial evaluating its safety and efficacy in patients with intermittent claudication has been completed.
Ad2/HIF-1α/VP16 has been evaluated in one completed Phase 2 clinical trial, identified as NCT00117650. This randomized, double-blind, placebo-controlled study enrolled 289 patients with intermittent claudication, peripheral vascular disease, and atherosclerosis across the United States, Germany, and the United Kingdom.
Ad2/HIF-1α/VP16 is also referred to as Ad2/Hypoxia Inducible Factor (HIF)-1α/VP16 gene transfer. The completed Phase 2 clinical trial NCT00117650 used this alternative name in its official title, describing the same investigational gene therapy for intermittent claudication.