Mesoblast Limited, global leader in allogeneic cellular medicines for inflammatory diseases, announced that it has received ethics approval to include Australian hospitals in thePhase 3 randomized controlled trial of remestemcel-L in ventilator-dependent COVID-19 patients with acute respiratory distress syndrome (ARDS).
Participating hospitals in Melbourne and Sydney ha ve been granted approval by the Human Research Ethics Committee of Monash Health and will join more than 17 leading US medical centers already in the Phase 3 trial. This study is being conducted by the US National Institutes of Health –funded Cardiothoracic Surgical Trials Network, and cleared by the US Food and Drug Administration (FDA).
Mesoblast Chief Executive Dr Silviu Itescu stated: “As an Australian company developing a potential treatment for COVID-19 ARDS, the primary cause of death in patients infected with COVID-19, we have a responsibility to evaluate remestemcel-L in Australian patients as the country continues to grapple with COVID-19.”Principal Investigator A/Prof. Tony Goldschlager said: “We are pleased that Monash Health is involved in this important COVID-19 trial, especially given the extensive experience we have had with Mesoblast’s mesenchymal lineage cells.”
The clinical protocol evaluating remestemcel-L in up to 300 patients in the Phase 3 trial was based on results from a pilot study using remestemcel-L under emergency compassionate care at Mt Sinai Hospital in New York, with 75% (nine of 12) of patients with moderate to severe ARDS successfully taken off a ventilator and discharged from hospital within a median of 10 days. The Phase 3 trial is enrolling ventilator-dependent patients in intensive care units with moderate to severe COVID-19 ARDS randomized (1:1) to receive either two intravenous infusions of remestemcel-L three to fi ve days apart or placebo on top of maximal care.
The primary endpoint is all-cause mortality within 30 days of randomization, with the key secondary endpoint being the number of days off mechanical ventilator support.The trial’s independent Data Safety Monitoring Board (DSMB) plans to complete an interim analysis this month in the trial’s first 90 patients randomized in the US after they have completed 30 days of follow up. After review of the safety and efficacy data, the DSMB will provide a recommendat ion toMesoblast on whether the trial should proceed as planned, or stop early.
About Remestemcel-L
Mesoblast’s lead product candidate, remestemcel-L, is an investigational therapy comprising culture-expanded mesenchymal stem cells derived from the bone marrow of an unrelated donor. Remestemcel-L is believed to have immunomodulatory properties to counteract the cytokine storms that are implicated in various inflammatory conditions by down-regulating the production of pro-inflammatory cytokines, increasing production of anti-inflammatory cytokines, and enabling recruitment of naturally occurring anti-inflammatory cells to involved tissues.
About Mesoblast
Mesoblast Limited is a world leader in developing allogeneic (off-the-shelf) cel lular 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 has a strong and extensive global intellectual property (IP) portfolio with protection extending through to at least 2040 in all major markets. The Company’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.
