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NEW YORK, Jan. 30, 2022 (GLOBE NEWSWIRE) — Mesoblast Limited (NASDAQ:MESO, ASX:MSB)), global leader in allogeneic cellular medicines for inflammatory diseases, today provided an operational and financial activity report for the second quarter ended December 31, 2021.
Key operational highlights for the quarter
Activities supporting potential resubmission of the Biologics License Application (BLA) for remestemcel-L in the treatment of children with steroid-refractory acute graft versus host disease (SR-aGVHD):
- Meeting held with the US Food and Drug Administration’s (FDA) Office of Tissues and Advanced Therapies (OTAT) to address potency assay and chemistry, manufacturing and controls (CMC) items identified in the complete response letter (CRL) for remestemcel-L in the treatment of SR-aGVHD in children
- OTAT indicated that the in vitro immunomodulatory activity Mesoblast intends to measure for potency of the product is reasonable and that the relevance of this activity to clinical outcomes should be established
- Results from an investigator-initiated study, published in the peer-reviewed journal Bone Marrow Transplantation1, in children with SR-aGVHD stratified by baseline levels of inflammatory biomarkers, showed that remestemcel-L treatment was associated with 64% survival in children with biomarker levels predictive for highest mortality compared with only 10% survival (p=0.01) in matched controls treated with other available therapies, including ruxolitinib or other biologics
- These data provide strong supporting evidence that the proposed anti-inflammatory and immunomodulatory mechanism of action of remestemcel-L is responsible for the improved survival in patients with SR-aGVHD
- Mesoblast has now generated substantial new data that it believes establish the relevance of the proposed potency assay measuring remestemcel-L’s in vitro anti-inflammatory and immunomodulatory activity to the in vivo clinical effect of the product in the Phase 3 trial in children with SR-aGVHD, including survival and biomarkers of in vivo activity
- Mesoblast will provide these new data to OTAT and address all other outstanding items as required for resubmission of the BLA
- Mesoblast continues to be in a well-established process with FDA’s Center for Biologics Evaluation and Research (CBER), and if the resubmission is accepted, CBER will consider the adequacy of the clinical data in the context of the related CMC issues noted above.
Activities regarding the rexlemestrocel-L Phase 3 programs in chronic low back pain (CLBP) and chronic heart failure (CHF):
- Received feedback from FDA’s OTAT that it agrees with Mesoblast’s proposal for pain reduction at 12 months as the primary endpoint for a pivotal trial to confirm the observed pain reduction with rexlemestrocel-L in the first Phase 3 trial in patients with CLBP due to degenerative disc disease (DDD) refractory to available therapies, including opioids
- Received feedback from FDA’s OTAT confirming that reduction in major adverse cardiovascular events (MACE) of cardiovascular mortality or irreversible morbidity (non-fatal heart attack or stroke) is an acceptable clinically meaningful endpoint for determining the treatment benefit of rexlemestrocel-L for patients with chronic heart failure and low ejection fraction (HFrEF)
Full story available on Benzinga.com
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