Coronavirus: breakthrough nears in stem-cell treatment

Australian biotech company weeks away from learning if it has found a world-first treatment for coronavirus.

Mesoblast chief medical officer Fred Grossman.

Australian biotech company Mesoblast is just weeks away from learning if it has found a world-first breakthrough in the treatment for coronavirus.

The Australian/US company is awaiting the interim results of a 300-patient trial to see if its stem-cell based treatment confirms the promise of an early trial which produced a stunning survival rate among seriously ill COVID-19 patients.

If the interim results confirm the effectiveness of the treatment, the company will move quickly to seek FDA approval, raising the possibility that an Australian company will spearhead the world’s first lifesaving treatment for the deadly virus.

Mesoblast’s chief medical officer Fred Grossman told The Australian from New York that he had confidence that the trial would prove the effectiveness of the treatment, but cautioned that nothing was guaranteed until the final results were known.

“I have confidence that we will be successful ... but a lot of this will depend on continuing discussions with the FDA,’ Dr Grossman said. “We have every intention if this trial is positive, if it gives us a definitive answer, of applying for (FDA) approval.’

Mesoblast CEO Silviu Itescu in Melbourne in 2018. Picture: Stuart McEvoy

Mesoblast, founded in 2004 by Australian scientist and entrepreneur Silviu Itescu and backed by shareholders including billionaire industrialist Anthony Pratt, has developed a unique stem cell treatment which appears to counteract the potentially deadly impact on the lungs caused by the coronavirus.

The treatment was developed to treat a range of serious medical conditions including severe inflammation or immune system failure, but when the coronavirus emerged, Dr Grossman said the company immediately saw its potential to treat COVID-19.

“We realised how perfect these cells would be in treating those patients (with COVID-19) who are on a ventilator with moderate to severe acute respiratory syndrome and who have the highest mortality,’ he said.

In April, Mt Sinai Hospital in New York gave Mesoblast’s stem cells to 12 severely ill Covid patients on ventilators in ICU and found there was a survival rate of 75 per cent, compared with only 9 per cent for ventilator-dependent Covid patients without the Mesoblast treatment.

To test these initial results, the company is nearing the end of a 300-patient randomised, placebo-controlled trial for Covid patients on ventilators at more than 20 US hospitals.

The forthcoming interim findings of the trial, which began in May, will be assessed by an independent team of experts. The full trial is expected to be completed by October but depending on interim results, the team of experts could recommend fast tracking the treatment for FDA approval immediately.

Mesoblast’s remestemcel-L treatment involves infusing the body of a seriously ill Covid patient with mesenchymal stem cells which migrate to the lungs.

The cells then release anti-inflammatory materials which counters the deadly acute respiratory disease syndrome (ARDS) which is caused by a cytosine storm in the lungs of infected patients.

By reducing this dangerous inflammation in the lungs, the treatment greatly increases the prospects of survival in patients whose condition has become so serious that they require ventilators.

“This is revolutionary medicine,’ Dr Grossman says. “The mechanism by which the cells work lend themselves to a whole host of significant inflammatory diseases.’

Mesoblast, which is listed on the Australian Securities Exchange and also on the Nasdaq, has offices in Australia, the US and Singapore.

Cameron Stewart is also US Contributor for Sky News Australia