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PVS-10200 · 1 trial · 1 indication
Major Adverse Events are: - Death - Major amputation - Procedural related serious adverse events - Investigational product related serious adverse events
| Arm | Type | Description |
|---|---|---|
| PVS-10200 | OTHER | Each subject will receive one treatment of PVS-10200 delivered by ultrasound guided injection perivascular to the region of the target lesion within 24 hours of the completed angioplasty and stent placement. |
| Name | Type | Description |
|---|---|---|
| PVS-10200 | BIOLOGICAL | PVS-10200 is composed of allogeneic human aortic endothelial cells cultured in a gelatin matrix. |
Inclusion Criteria: 1. The subject has signed the informed consent document and patient information leaflet. 2. Male and female subject ≥ 18 years of age at the time of consent. 3. If female, the subject is (a) at least 1 year post-menopausal, or (b) surgically sterile, or (c) of child-bearing pote...
PVS-10200 is a monoclonal antibody being investigated for the treatment of peripheral artery disease, specifically for restenosis in patients with this condition. It is currently in Phase 1 clinical development and is considered investigational, meaning it has not been approved for use.
PVS-10200 is a monoclonal antibody, but its specific molecular target has not been disclosed. It is being studied for its potential to treat restenosis in patients with peripheral artery disease, a condition involving narrowed arteries in the limbs.
PVS-10200 is being developed by Takeda Pharmaceutical Company Limited, a global biopharmaceutical company. Takeda is listed on the stock exchange under the ticker symbol TAK.
PVS-10200 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still undergoing clinical trials to evaluate its safety and efficacy.
PVS-10200 has been studied in one completed Phase 1 clinical trial with the identifier NCT01099215. This trial, titled 'Study of PVS-10200 for the Treatment of Restenosis in Patients With Peripheral Artery Disease (TRIUMPH)', enrolled 21 participants in France and was not randomized or blinded.