With US trials for its potential COVID-19 treatment now at the Phase 3 stage, regenerative health company Mesoblast (ASX: MSB, NASDAQ: MESO) has today received a breakthrough for testing the stem cell-based intravenous solution in Australia.
The Melbourne-based group has today announced it 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).
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 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).
"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," says Mesoblast chief executive and founder Dr Silviu Itescu (pictured).
"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," adds principal investigator, Associate Professor Tony Goldschlager.
The company's shares have skyrocketed since April when restemcel-L produced encouraging results in a small cohort of severely ill COVID-19 patients in New York, with 83 per cent surviving compared to a 12 per cent rate at the time for those in similar circumstances.
Before COVID-19 and the company's pivot to treat the virus, Mesoblast was worth $1.56 billion. Today it is worth more than $3 billion.
Updated at 11:36am AEST on 2 September 2020.
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