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
- Forums
- ASX - By Stock
- Cell Therapy News/Articles
https://www.targetedonc.com/view/bla-for-remestemcel-l-to-treat-p...
-
- There are more pages in this discussion • 425 more messages in this thread...
You’re viewing a single post only. To view the entire thread just sign in or Join Now (FREE)
Featured News
Add MSB (ASX) to my watchlist
(20min delay)
|
|||||
Last
$1.14 |
Change
0.015(1.33%) |
Mkt cap ! $1.307B |
Open | High | Low | Value | Volume |
$1.13 | $1.18 | $1.13 | $2.807M | 2.441M |
Buyers (Bids)
No. | Vol. | Price($) |
---|---|---|
11 | 14438 | $1.14 |
Sellers (Offers)
Price($) | Vol. | No. |
---|---|---|
$1.15 | 10959 | 12 |
View Market Depth
No. | Vol. | Price($) |
---|---|---|
3 | 10347 | 1.140 |
19 | 53033 | 1.135 |
14 | 78471 | 1.130 |
8 | 122560 | 1.125 |
7 | 37258 | 1.120 |
Price($) | Vol. | No. |
---|---|---|
1.145 | 11294 | 8 |
1.150 | 34098 | 8 |
1.155 | 91868 | 6 |
1.160 | 58192 | 8 |
1.165 | 35020 | 6 |
Last trade - 12.47pm 30/09/2024 (20 minute delay) ? |
Featured News
MSB (ASX) Chart |