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- Mesoblast (MSB) has missed the mark in a phase three trial for chronic heart failure but may have found a new path for its stem cell treatment
- The company gave 537 patients with advance chronic heart failure its cell therapy drug, known as Revascor
- But the results revealed there was no reduction in the recurring non-fatal decompensated heart failure events, which was the main point of the trial
- However, the trial did show that Revascor significantly reduces cardiovascular mortality when used in the early stages of heart failure patients
- Mesoblast believes the mortality benefit found in the phase three trial will support a potential path for Revascor to be approved in patients with advanced chronic heart failure
- Therefore, it may have the potential to change the treatment plan for patients with advanced chronic heart failure
- On the market this morning, Mesoblast is down 12.3 per cent and trading at $3.98 per share
Mesoblast (MSB) has missed the mark in a phase three trial for chronic heart failure but may have found a new path for its stem cell treatment.
The trial was evaluating its cell therapy, rexlemestrocel-L (also known as Revascor), as an add on treatment to the standard of care for the reduction of reoccurring non-fatal heart failure.
The trial
Mesoblast trialled Revascor on 537 patients with advance chronic heart failure and over the past 30 months has been collecting follow-up data.
But the results revealed there was no reduction in the recurring non-fatal decompensated heart failure events, which was the main point of the trial.
Decompensated heart failure is when your heart can not eject or accommodate blood within the physiological pressure levels.
However, there is a silver lining in the results: the company found that patients who received both Revascor and maximal therapies had a 60 per cent reduction in the occurrence of heart attacks and strokes and 60 per cent reduction in death from heart causes when treated at an early stage.
The data from the trial means Revascor reduces mortality with existing drugs that reduce hospitalisation rates, but does not significantly impact cardiac mortality.
“There is an urgent need for new therapies that can reduce the high death rates in heart failure patients by different modes of action from existing drugs which reduce hospitalization rates but have not significantly reduced mortality rates,” Mesoblast Chief Executive Dr Silviu Itescu said.
“The reduction in mortality seen with Revascor in advanced chronic heart failure underlines the power of this technology and the commitment of Mesoblast to address diseases in patients with a high unmet need which are refractory to existing therapies,’ he added.
Mesoblast believes the mortality benefit found in the phase three trial will support a potential path for Revascor to be approved in patients with advanced chronic heart failure. The company is planning to meet and discuss the results with the United States Food and Drug Administration.
“The trial results show that Revascor significantly reduces cardiovascular mortality when used early in heart failure patients at risk of disease progression, and provides durable protection from heart attacks or strokes in these vulnerable patients,” the trial’s co-principal investigator, Dr Emerson Perin, said.
“New therapies have not materially reduced the high death rates from cardiovascular disease which is why these data have the potential to change the
the treatment paradigm for patients with advanced chronic heart failure,” he added.
On the market this morning, Mesoblast is down 12.3 per cent and is trading at $3.98 per share at 11:16 am AEDT.
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