Stage (next event)
Catalyst Info & Data Links
TITLE: REMESTEMCEL-L in Crohn’s Disease
ClinicalTrial.gov (NCT04548583): Study of Mesenchymal Stem Cells for the Treatment of Medically Refractory Crohn's Colitis
WHAT IS THE CATALYST EVENT?
Phase 2 Data
WHEN WILL THE EVENT (OR DID THE EVENT) OCCUR?
Mechanism of Action
MECHANISM OF ACTION / RATIONALE
remestemcel-L is a tier 2 product candidate which consists of 100 million mesenchymal stem cells (MSCs). All doses of remestemcel-L for the treatment of Crohn’s disease consist of 100 to 200 million MSCs delivered intravenously in a multiple dose regime.
remestemcel-L has demonstrated immunomodulatory properties in preclinical studies to regulate T-cell mediated inflammatory responses by inhibiting T-cell proliferation and down-regulating the production of the pro-inflammatory cytokines, including tumor necrosis factor-alpha, or TNF-alpha, and interferon gamma. More critically, MLCs have been shown to be capable of effective down-regulation of Th17 cells, reduction in IL-17 levels, and induction of FOXP3 regulatory T cells. These inflammatory pathways are acknowledged to be central to the pathogenesis of Crohn’s disease and other inflammatory conditions.
The United States has the highest prevalence of the disease, with more than 600,000 people afflicted and approximately 20,000 new cases diagnosed each year.
Of the 600,000 American patients, studies have shown that approximately 8-20% are unresponsive, resistant or intolerant to existing treatments, which include corticosteroids, immunosuppressants and biologics2.
The global Crohn’s disease therapeutics market was estimated to be worth $4.4 billion in 2012.
Updated by HC
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