| Quantity: | |
|---|---|
Clinically relevant – Mimics human SSc: skin fibrosis, collagen accumulation, and autoimmune features.
Well-characterized endpoints – Clinical score, body weight, histopathology (H&E, Masson's trichrome), collagen quantification.
Mechanism-driven – BLM induces fibrosis through DNA damage and inflammatory pathways, closely mimicking human disease pathogenesis.
Translational value – Ideal for testing anti-fibrotic agents (TGF-β inhibitors, tyrosine kinase inhibitors), immunomodulators, and biologics.
IND-ready data packages – Studies can be conducted in accordance with GLP principles.
Representative data from our BLM Induced NHP SSc model:
BLM Induced NHP SSc Model
• Efficacy testing of anti-fibrotic agents (TGF-β inhibitors, tyrosine kinase inhibitors, pirfenidone, nintedanib)
• Target validation for fibrosis pathways (collagen synthesis, TGF-β signaling)
• Biomarker discovery (collagen metabolites, autoantibodies)
• Mechanism of action (MOA) studies
• IND-enabling toxicology and safety pharmacology studies
Parameter | Specification |
Species | Cynomolgus macaque (Macaca fascicularis) |
Induction method | Intradermal injections of bleomycin (BLM), multiple sites, repeated dosing for 4–8 weeks |
Study duration | 6–10 weeks (induction + treatment phase) |
Key endpoints | Clinical score (skin thickness, hardness); body weight; histopathology (H&E, Masson's trichrome for collagen deposition); dermal thickness measurement; optional: autoantibody titers, hydroxyproline assay |
Data package | Raw data, analysis reports, histology slides (H&E, Masson), clinical photographs, bioinformatics (optional) |
Q: How does bleomycin induce SSc-like fibrosis?
A: Bleomycin causes DNA damage and oxidative stress, triggering inflammatory and fibrotic pathways including TGF-β activation, leading to excessive collagen production and deposition in the skin.
Q: What are the key similarities with human systemic sclerosis?
A: The model exhibits dermal thickening, collagen accumulation (Masson's trichrome), and can show autoantibody production, closely mimicking human SSc pathology.
Q: Can this model be used for IND-enabling studies?
A: Yes. Studies can be conducted in accordance with GLP principles for regulatory submissions (FDA, EMA).
Q: Do you offer customized study protocols (e.g., different BLM doses, administration routes)?
A: Absolutely. Our scientific team tailors BLM dosing regimens, injection schedules, and endpoint analyses to your specific drug candidate.
