@nasdaq/phase-2-trial-results-of-mesoblasts-cell-therapy-show-dose-related-improvements-in-biologic-refractory-rheumatoid-arthritis AMEX +20 Min.
With respect to the primary endpoint, allogeneic MPC treatment, including MPC-06-ID, was well tolerated with the most frequently reported adverse event, back pain, occurring across all patient groups.With respect to primary efficacy endpoints, the FDA has provided guidelines on how to evaluate patient response, utilizing a composite endpoint based on achieving minimally important clinical differences, or MICD, in both pain and function from baseline.
Learn more about Mesoblast's adult stem cell research and the potential to cure human disease. These results support the potential of our allogeneic cell therapy to be positioned as a first-line treatment option for biologic refractory patients, where there is a clear need for safe and effective treatments.
Phase 2 Trial Results of Mesoblast’s Cell Therapy Show Dose-Related Improvements in Biologic Refractory Rheumatoid Arthritis High disease activity is defined as DAS28 score >5.1; moderate disease activity is defined as DAS28 scores between 5.1-3.2; low disease activity and remission are defined as DAS28 scores of In large animal studies, a single intravenous infusion of Mesoblast’s allogeneic MPCs resulted in concomitant inhibition of TNF-alpha, IL-6 and IL-17 inflammatory pathways in the inflamed joints, and substantially ameliorated clinical disease.
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In the Phase 2 trial, 60% of patients met this criterion.
Biologic refractory RA patients who have received prior anti-TNF or other biologic agents continue to have active inflammatory pathways, and the broad, concomitant targeting of multiple cytokine networks by MPCs may result in clinically meaningful outcomes in this patient group. With respect to the primary endpoint, allogeneic MPC treatment, including MPC-06-ID, was well tolerated with the most frequently reported adverse event, back pain, occurring across all patient groups.
To access the call only, dial 1 855 881 1339 (US), 1800 870 643 or 1800 809 971 (Australia) or +61 2 9007 3187 (outside of the US and Australia). (remestemcel-L) in the treatment of steroid-refractory acute graft versus host disease in children. Mesoblast Chief Executive Dr Silviu Itescu stated: “We are very pleased with the substantial progress made by the Company as we seek US marketing approval for our lead product candidate RYONCIL
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Trial Results: MPC-06-ID Phase 2 Chronic Low Back Pain Due to Disc Degeneration Clinical Trial. Endomyocardial injections of MPCs in patients with chronic heart failure were feasible and safe.
Mesoblast to Host Analyst Call on Financial Results for Period Ended March 31, 2020 . Copyright © 1998-2020 wallstreet:online AG - Alle Rechte vorbehalten. acute graft versus host disease (acute GvHD). more specifically, among 18 Class II/III CHF patients with baseline LVESV > 100 ml, 5/7 (71%) placebo-treated versus 0/11 150 million MPC-treated experienced one or more HF-MACE events over 36 months (p=0.0007).
December 31, 2019.
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