Mesoblast Limited (ASX:MSB; Nasdaq: MESO) today announced that the company will this week present corporate updates at the annual Cantor Fitzgerald Global Healthcare Conference and the Ladenburg Thalmann Healthcare Conference, both being held in New York City, New York.
The Company presentations will focus on the Phase 3 clinical trials of its lead product candidates in acute graft versus host disease (aGVHD), chronic low back pain due to disc degeneration (CLBP), and chronic heart failure (CHF), and on potential regulatory strategies to achieve accelerated approval pathways for these product candidates based on the serious and life-threatening nature of the diseases and the cumulative clinical results obtained to date using the Company’s proprietary mesenchymal lineage cell technology platforms.
The Company has significant upcoming milestones in regard to these Phase 3 assets, has strengthened its financial position post the recently completed institutional and retail entitlement offers, and continues to be in active discussions with several potential strategic partners, including Mallinckrodt Pharmaceuticals plc.
Mesoblast’s lead product candidate for treatment of steroid-refractory acute aGVHD is MSC-100-IV, and this product candidate has been granted a Fast Track designation by the United States Food and Drug Administration (FDA). MSC-100-IV has been used extensively under an Expanded Access Program with very encouraging results on both overall response and survival. The open-label Phase 3 trial in up to 60 children successfully met a pre-specified interim futility analysis of the primary endpoint in November 2016, and the trial is expected to have top-line data readout in 2H CY17.