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- Riferminogene pecaplasmid
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Riferminogene pecaplasmid | CAS No: 1001859-46-6 | GMP-certified suppliers
A medication that supports recovery in limb amputation and peripheral vascular disease by promoting local angiogenesis and improving blood flow in ischemic tissues.
Primary indications
- Investigated for use/treatment in amputation (limb) and peripheral vascular disease
Product Snapshot
- Riferminogene pecaplasmid is a gene therapy formulation designed for local administration
- It is primarily investigated for applications in limb amputation and peripheral vascular disease
- The product is currently in the investigational stage without approved regulatory status
Clinical Overview
Clinically, riferminogene pecaplasmid is under investigation for the treatment of limb amputation recovery and peripheral vascular disease, conditions characterized by impaired blood flow and tissue ischemia. The therapeutic rationale is based on its ability to promote angiogenesis, thereby improving vascular density and tissue perfusion in ischemic limbs.
The mechanism of action centers on localized gene delivery using the pCOR plasmid, which drives expression of FGF-1 in muscle tissue following intramuscular administration. FGF-1 is a potent angiogenic growth factor that stimulates endothelial cell proliferation and differentiation. The pCOR vector offers several safety advantages: it replicates only in select laboratory strains of Escherichia coli, excludes antibiotic resistance genes, and lacks immunostimulatory motifs commonly found in other plasmid vectors like ColE1. These features reduce the risk of unintended environmental spread and immune reactions.
Pharmacokinetic and metabolism data for riferminogene pecaplasmid are not extensively characterized in clinical settings due to its gene therapy nature. Preclinical models demonstrate that expression of FGF-1 persists locally for several weeks following administration. In ischemic animal models, delivery of NV1FGF has resulted in significant enhancement of large conductance and small resistance vessel formation in affected muscles, supporting its pro-angiogenic effect.
Safety and toxicity evaluations have focused on vector-related immunogenicity and potential off-target effects. To date, no antibiotic resistance transfer or systemic toxicity has been reported with the use of this plasmid vector in preclinical studies. Clinical safety data remain limited given the investigational status.
In the context of active pharmaceutical ingredient (API) sourcing, riferminogene pecaplasmid requires stringent quality controls including plasmid purity, sequence verification, endotoxin levels, and absence of contaminating bacterial DNA or proteins. Manufacturing must comply with Good Manufacturing Practice (GMP) standards for gene therapy products to ensure consistent functionality and biosafety. The specialized nature of this plasmid-based API necessitates selection of experienced suppliers with validated production and analytical capabilities.
Identification & chemistry
| Generic name | Riferminogene pecaplasmid |
|---|---|
| Molecule type | Biotech |
| CAS | 1001859-46-6 |
| UNII | 3G30P7ME1J |
| DrugBank ID | DB06394 |
Pharmacology
| Summary | NV1FGF is a plasmid-based gene therapy designed for local expression of fibroblast growth factor-1 (FGF-1) to promote angiogenesis. Its biosafe pCOR plasmid backbone limits replication to specific laboratory E. coli strains and excludes antibiotic resistance and immunostimulatory sequences. NV1FGF enhances vascular regeneration by stimulating the formation of conductance vessels and resistance arteries in ischemic tissues. |
|---|---|
| Mechanism of action | NV1FGF is a novel pCOR DNA plasmid–based gene delivery system for local expression of FGF-1. The pCOR plasmid backbone has several features that increase biosafety. These attributes include replication in only a narrow host range of laboratory, but not wild type, Escherichia coli strains, absence of an antibiotic-resistance gene, and lack of the potentially immunostimulatory sequence motifs found in ColE1 plasmids. Preclinical studies of intramuscular administration of NV1FGF have demonstrated that local expression of FGF-1 persists for several weeks. The angiogenic effect of NV1FGF was confirmed in the more severe animal model. The administration of NV1FGF in the hypercholesterolemic hamster model of hindlimb ischemia significantly enhanced the formation of large conductance vessels as well as small resistance arteries in ischemia-injured muscles. |
Formulation & handling
- Riferminogene pecaplasmid is a biotech investigational solid formulation intended for injectable use.
- Due to its biologic nature, it requires careful handling to maintain stability and prevent degradation.
- Storage conditions should minimize exposure to temperature fluctuations and moisture to preserve API integrity.
Regulatory status
Riferminogene pecaplasmid is a type of Antibacterials
Antibacterials, a category of pharmaceutical active pharmaceutical ingredients (APIs), play a crucial role in combating bacterial infections. These APIs are chemical compounds that target and inhibit the growth or kill bacteria, helping to eliminate harmful bacterial pathogens from the body.
Antibacterials are essential for the treatment of various bacterial infections, including respiratory tract infections, urinary tract infections, skin and soft tissue infections, and more. They are commonly prescribed by healthcare professionals to combat both mild and severe bacterial infections.
Within the category of antibacterials, there are different classes and subclasses of APIs, each with distinct mechanisms of action and target bacteria. Some commonly used antibacterials include penicillins, cephalosporins, tetracyclines, macrolides, and fluoroquinolones. These APIs work by interfering with various aspects of bacterial cellular processes, such as cell wall synthesis, protein synthesis, DNA replication, or enzyme activity.
The development and production of antibacterial APIs require stringent quality control measures to ensure their safety, efficacy, and purity. Pharmaceutical manufacturers must adhere to Good Manufacturing Practices (GMP) and follow rigorous testing protocols to guarantee the quality and consistency of these APIs.
As bacterial resistance to antibiotics continues to be a significant concern, ongoing research and development efforts aim to discover and develop new antibacterial APIs. The evolution of antibacterials plays a crucial role in combating emerging bacterial strains and ensuring effective treatment options for infectious diseases.
In summary, antibacterials are a vital category of pharmaceutical APIs used to treat bacterial infections. They are designed to inhibit or kill bacteria, and their development requires strict adherence to quality control standards. By continually advancing research in this field, scientists and pharmaceutical companies can contribute to the ongoing battle against bacterial infections.
