Cell Therapy News/Articles, page-17821

https://www.targetedonc.com/view/bla-for-remestemcel-l-to-treat-pediatric-sr-agvhd-resubmitted-to-fda

Summary below of the phase 3 GVHD001/002 clinical trial (NCT02336230) which supports the BLA.
Please fix if you find holes.

Outcome Measure	Result
Overall Response Rate (ORR) at Day 28	70.4%
Comparison to Control ORR (P-value)	Exceeded control value of 45% (P = .0003)
Survival Rate at Day 100 (Responders)	87%
Survival Rate at Day 100 (Non-responders)	47%
Comparison to Best Available Therapy	Response at Day 28: 67% vs. 10% in control group
	Survival at Day 180: 67% vs. 10% in control group
Dosage Regimen	Intravenous remestemcel-L at 2 x 10^6 MSC/kg twice per week for 4 weeks
Patient Eligibility	Ages 2 months to 17 years, grade B-D aGVHD requiring systemic corticosteroid therapy, adequate performance status and renal function
Trial Endpoints	Primary: ORR at 28 days
	Secondary: OS at 100 days, ORR at 56 and 100 days