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Also known as NV1FGF, XRP0038
riferminogene pecaplasmid · 6 trials · 4 indications
| Arm | Type | Description |
|---|---|---|
| Riferminogene pecaplasmid | EXPERIMENTAL | 4 administrations of riferminogene pecaplasmid 4 mg at 2-week intervals |
| Placebo | PLACEBO_COMPARATOR | 4 administrations of placebo (for riferminogene pecaplasmid) at 2-week intervals |
| NV1FGF 16 mg | EXPERIMENTAL | 4 administrations at 2-week interval of 4mg at each administration |
| NV1FGF 32 mg | EXPERIMENTAL | 4 administrations at 2-week interval of 8mg at each administration |
| NV1FGF 500 μg | EXPERIMENTAL | 8 intramuscular injections for a total of 500 μg administered in one single administration 3 to 8 days before major amputation |
| NV1FGF 2000 μg | EXPERIMENTAL | 8 intramuscular injections for a total of 2000 μg administered in one single administration 3 to 8 days before major amputation |
| NV1FGF 4000 μg | EXPERIMENTAL | 8 intramuscular injections for a total of 4000 μg administered in one single administration 3 to 8 days before major amputation |
| Name | Type | Description |
|---|---|---|
| riferminogene pecaplasmid | BIOLOGICAL | Formulation: 5 ml glass vials containing 2,5 ml riferminogene pecaplasmid Route: intramuscular (IM) injection of 2.5 mL in the ischemic leg to be treated |
| Placebo (for riferminogene pecaplasmid) | BIOLOGICAL | Formulation: 5 ml glass vials containing 2,5 ml placebo Route: IM injection of 2.5 mL in the ischemic leg to be treated |
| XRP0038 (NV1FGF) | DRUG | Pharmaceutical form:solution Route of administration: intramuscular |
| placebo | DRUG | Pharmaceutical form:solution Route of administration: intramuscular |
Inclusion Criteria: * Having peripheral artery disease at the stage of Critical Limb Ischemia (CLI) with skin lesions (either ulcer(s) or gangrene); * With objective evidence of CLI such as ankle systolic pressure \<70 mmHg and/or toe systolic pressure \<50 mmHg or transcutaneous oxygen pressure (T...
Riferminogene pecaplasmid is an investigational gene therapy developed by Sanofi for peripheral vascular diseases, including critical limb ischemia. It is designed to deliver genetic material that promotes new blood vessel formation in patients with reduced blood flow to the limbs. It is not an approved medicine and remains in clinical development.
Riferminogene pecaplasmid is being studied for peripheral vascular diseases, specifically critical limb ischemia in patients with skin lesions. The goal is to improve blood flow to affected limbs. It has been tested in a Phase 3 trial but is not approved for any indication.
Riferminogene pecaplasmid is developed by Sanofi, which trades on the New York Stock Exchange under the ticker SNY. Sanofi sponsored the Phase 3 clinical program evaluating the gene therapy in critical limb ischemia.
Riferminogene pecaplasmid has completed a Phase 3 clinical trial. It is an investigational gene therapy and is not FDA approved. No active trials are currently listed for this asset, and further development status has not been announced.
Riferminogene pecaplasmid was evaluated in one completed Phase 3 trial, NCT00566657, titled Efficacy and Safety of XRP0038/NV1FGF in Critical Limb Ischemia Patients With Skin Lesions. The randomized, double-blind, placebo-controlled study enrolled 525 patients across 32 countries, including the United States, Japan, and multiple European nations.
Yes. Riferminogene pecaplasmid is also known as XRP0038 and NV1FGF. These names refer to the same Sanofi gene therapy candidate, which was studied in critical limb ischemia patients with skin lesions under the trial title referencing XRP0038/NV1FGF.