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항목
CGTCurated CoreFDAstaleApproved
nadofaragene firadenovec (Adstiladrin, rAd-IFNα/Syn3, nadofaragene firadenovec-vncg)
Ferring Pharmaceuticals·IFNα2b (adenoviral)
10 trials
Overview
Program
Adstiladrin (nadofaragene firadenovec)
Overview
Company
Ferring Pharmaceuticals
Overview
Modality
CGT
Overview
Target
IFNα2b (adenoviral)
Overview
Indication
High-risk BCG-unresponsive non-muscle invasive bladder cancer (NMIBC)
Overview
Phase
APPROVED
Overview
Status
APPROVED
Overview
Content status
Curated Core
Overview
Data Confidence
Editorial scope · Curated Core
Overview
Development Signal
Development Signal · Established
Overview
Approval status
FDA approved
Positioning
Key differentiator
Local bladder gene delivery avoiding systemic AAV exposure
Positioning
Known limitation
downregulation of mTOR and STAT3 at the single-cell resolution, both in vitro and in vivo
Technology
Vector
rAd-IFNα/Syn3
MoA
Mechanism
Nadofaragene firadenovec is a non-replicating adenoviral vector delivering IFNα2b cDNA to bladder urothelium for BCG-unresponsive NMIBC.
MoA
Biomarker
Complete response at 3/6/12 months (cystoscopy, cytology, biopsy).
Toxicology
Species
Cynomolgus monkey
Toxicology
Major finding
Instillation-site reactions, bladder spasm, micturition urgency; systemic IFN effects uncommon.
Toxicology
CRS
N/A
Clinical
Safety signal
Instillation-site reactions, bladder spasm, micturition urgency; systemic IFN effects uncommon.
Clinical
Program phase
APPROVED
Clinical
Trial activity
6 recruiting · 3 completed