Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
HGF plasmid · 2 trials · 4 indications
Wound healing measured by change in mean total wound area of all ischemic ulcers at Month 3 and Month 6
| Arm | Type | Description |
|---|---|---|
| Active Group | ACTIVE_COMPARATOR | 4.0 mg AMG0001 via intramuscular injections on days 0, 14, and 28 |
| Placebo Group | PLACEBO_COMPARATOR | Placebo (saline) via intramuscular injections on days 0, 14, and 28 |
| 1 | ACTIVE_COMPARATOR | 0.4 mg AMG0001 on days 0, 14, and 28 |
| 2 | ACTIVE_COMPARATOR | 4.0 mg AMG0001 on days 0, 14, and 28 |
| 3 | ACTIVE_COMPARATOR | 4.0 mg AMG0001 on days 0 and 28; placebo on day 14 |
| 4 | PLACEBO_COMPARATOR | Placebo (saline) on days 0, 14, and 28 |
| Name | Type | Description |
|---|---|---|
| HGF plasmid | GENETIC | Intramuscular injections into the index leg on days 0, 14, and 28 |
| Placebo | GENETIC | Intramuscular injections into the index leg on days 0, 14, and 28 |
Inclusion Criteria: 1. Subjects will have an appropriately sized peripheral ischemic ulcer(s). 2. Subjects will have one or both of the following hemodynamic indicators of severe peripheral arterial occlusive disease: 1. Ankle systolic pressure (in either the dorsalis pedis or posterior tibial ...
HGF plasmid is an investigational gene therapy being studied for arterial occlusive disease, specifically critical limb ischemia, a severe form of peripheral vascular disease. It is designed to improve perfusion, or blood flow, in patients with this condition, including those with peripheral ischemic ulcers.
HGF plasmid delivers the gene for hepatocyte growth factor (HGF) via a plasmid vector. HGF is a protein that promotes angiogenesis, the formation of new blood vessels, which may help restore blood flow to ischemic tissues in patients with arterial occlusive disease.
HGF plasmid is being developed by BrainsWay Ltd., a company traded on the stock exchange under the ticker BWAY. The company is conducting clinical trials to evaluate the therapy's safety and efficacy for treating critical limb ischemia.
HGF plasmid is in Phase 2 clinical development. It is an investigational therapy, meaning it has not yet been approved by regulatory authorities. Two Phase 2 trials have been completed, both of which were randomized, double-blind, and placebo-controlled.
HGF plasmid has been studied in two completed Phase 2 trials. NCT00060892 enrolled 104 patients with critical limb ischemia, and NCT00189540 enrolled 27 patients with peripheral ischemic ulcers. Both trials were conducted in the United States and included patients aged 40 years and older.
HGF plasmid is a gene therapy that delivers the gene for hepatocyte growth factor (HGF) using a plasmid vector. It is not the same as the HGF protein itself, but rather a mechanism to produce HGF within the body to potentially improve blood flow in ischemic limbs.