NEW YORK, March 30, 2020 (GLOBE NEWSWIRE) -- Results from a sub-study of 70 patients with end-stage ischemic heart failure and a Left Ventricular Assist Device (LVAD), of 159 randomized patients who received either Mesoblast’s allogeneic mesenchymal precursor cell (MPC) product candidate Revascor® or saline, were presented on March 28 at the American College of Cardiology (ACC) Virtual Scientific Sessions. The full results from these 70 patients will be published in a peer-reviewed journal.
When compared to controls, in MPC recipients:
- the mean proportion of temporary weans from LVAD support was higher (64% vs 43%; relative risk (RR) 1.55; 95% confidence interval (CI) 1.01-2.36)
- the rate of mucosal bleeding was lower (4.2 vs 28/100 patient-months; RR 0.15; CI 0.05, 0.40)
- there were fewer serious adverse events (66.06 vs 120.35/100 patient-months; RR 0.55; CI 0.31,0.97)
- there were fewer readmissions (0.59 vs. 1.14/100 patient-days; RR 0.52; CI 0.28, 0.95).
The conclusions were:
- MPCs had a beneficial effect on LVAD weaning, major mucosal bleeding, serious adverse events, and readmissions in ischemic heart failure patients
- these findings may reflect the effect of MPCs on angiogenesis, inflammation and endothelial dysfunction, and warrant further clinical research.
End-stage ischemic heart failure patients with LVADs are older and have co-morbidities such as diabetes, thereby closely resembling the majority of patients in Mesoblast’s 566-patient Phase 3 trial for advanced chronic heart failure, planned to readout in mid-2020.
Revascor is being developed for use in end-stage ischemic heart failure patients with LVADs under existing FDA Regenerative Medicine Advanced Therapy (RMAT) and Orphan Drug Designations.
About Mesoblast
Mesoblast Limited (Nasdaq:MESO; ASX:MSB) is a world leader in developing allogeneic (off-the-shelf) cellular medicines. The Company has leveraged its proprietary mesenchymal lineage cell therapy technology platform to establish a broad portfolio of commercial products and late-stage product candidates. Mesoblast’s proprietary manufacturing processes yield industrial-scale, cryopreserved, off-the-shelf, cellular medicines. These cell therapies, with defined pharmaceutical release criteria, are planned to be readily available to patients worldwide.
Mesoblast has filed a Biologics License Application to the United States Food and Drug Administration (FDA) to seek approval of its product candidate RYONCIL™ (remestemcel-L) for steroid-refractory acute graft versus host disease (acute GvHD). Remestemcel-L is also being developed for other rare diseases. Mesoblast is completing Phase 3 trials for its product candidates for advanced heart failure and chronic low back pain. If approved, RYONCIL is expected to be launched in the United States in 2020 for pediatric steroid-refractory acute GVHD. Two products have been commercialized in Japan and Europe by Mesoblast’s licensees, and the Company has established commercial partnerships in Europe and China for certain Phase 3 assets.
Mesoblast has a strong and extensive global intellectual property (IP) portfolio with protection extending through to at least 2040 in all major markets. This IP position is expected to provide the Company with substantial commercial advantages as it develops its product candidates for these conditions.
Mesoblast has locations in Australia, the United States and Singapore and is listed on the Australian Securities Exchange (MSB) and on the Nasdaq (MESO). For more information, please see www.mesoblast.com, LinkedIn: Mesoblast Limited and Twitter: @Mesoblast
Forward-Looking Statements
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