The Mesoblast limited (ASX: MSB) share price is trading flat on Wednesday despite the release of a positive announcement.
In morning trade the allogeneic cellular medicines company's shares are changing hands for $5.24.
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What did Mesoblast announce?
This morning Mesoblast announced that it has received ethics approval to include Australian hospitals in the Phase 3 randomised controlled trial of remestemcel-L in ventilator-dependent COVID-19 patients with acute respiratory distress syndrome (ARDS).
According to the release, participating hospitals in Melbourne and Sydney have been granted approval by the Human Research Ethics Committee of Monash Health and will join more than 17 leading US medical centres that are already part of 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's Chief Executive, Dr Silviu Itescu, appeared to be pleased with the news.
He 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."
What does the trial consist of?
Mesoblast's phase 3 trial is enrolling ventilator-dependent patients in intensive care units with moderate to severe COVID-19 ARDS. They are randomised (1:1) to receive either two intravenous infusions of remestemcel-L three to five days apart or a placebo on top of maximal care.
The primary endpoint is all-cause mortality within 30 days of randomisation, with the key secondary endpoint being the number of days off mechanical ventilator support.
The trial's independent Data Safety Monitoring Board plans to complete an interim analysis this month in the trial's first 90 patients randomised in the United States after they have completed 30 days of follow up.
After the review of the safety and efficacy data, the Data Safety Monitoring Board will provide a recommendation to Mesoblast on whether the trial should proceed as planned or stop early.
That data should be released later this month and will be worth watching out for.
