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Search results for "Pharmacologic Substance[C1909]|Biological Agent[C307]|Gene Therapy Agent" in comments (approximate match)
Status:
Investigational
Source:
NCT01744223: Phase 1/Phase 2 Interventional Active, not recruiting Acute Lymphoblastic Leukemia
(2013)
Source URL:
Class:
STRUCTURALLY DIVERSE
Status:
Possibly Marketed Outside US
Source:
BLA125720
(2023)
Source URL:
First approved in 2023
Source:
BLA125720
Source URL:
Class:
STRUCTURALLY DIVERSE
Status:
Other
Class:
CONCEPT
Status:
US Approved Rx
(2024)
Source:
NDA217779
(2024)
Source URL:
First approved in 2024
Source:
NDA217779
Source URL:
Class (Stereo):
CHEMICAL (MIXED)
Status:
Investigational
Source:
INN:atesidorsen [INN]
Source URL:
Class:
NUCLEIC ACID
Status:
Investigational
Source:
NCT02658175: Phase 3 Interventional Completed Familial Chylomicronemia Syndrome
(2015)
Source URL:
Class:
NUCLEIC ACID
Status:
Investigational
Source:
NCT01578655: Phase 3 Interventional Completed Prostate Cancer
(2012)
Source URL:
Class:
NUCLEIC ACID
Status:
Investigational
Source:
NCT02525523: Phase 3 Interventional Completed Pouchitis
(2015)
Source URL:
Class:
NUCLEIC ACID
Alicaforsen is an antisense oligonucleotide targeted to down regulate the production of ICAM-1, a cell surface receptor which is involved in the process of inflammation. Alicaforsen selectively inhibits ICAM‑1 gene expression. Over-expression of ICAM‑1 occurs in a wide variety of inflammatory disorders, including ulcerative colitis (UC), pouchitis and tissues in the eye, gastrointestinal teact, lungs and skin. Alicaforsen is currently in development for the treatment of IBD. An enema formulation is currently in a pivotal Phase 3 study agreed with U.S., Canadian and European regulatory agencies in patients with active pouchitis. The study has completed enrollment of patients to approximately 40 trial centres across the U.S., Canada, Europe, and Israel, and is expected to report preliminary data in H1 2019. Under a rolling submission agreement with the FDA, Atlantic Healthcare has filed the nonclinical data package of its New Drug Application (NDA) for alicaforsen to treat pouchitis with the regulator. Alicaforsen has also been granted FDA Fast-Track designation, plus U.S. and European Orphan Drug designations for this indication.
Status:
Investigational
Source:
NCT01844817: Phase 2 Interventional Completed Pancreatic Cancer
(2013)
Source URL:
Class:
NUCLEIC ACID
Class:
NUCLEIC ACID
