Health: Mesoblast pushes ahead to the next stage of testing for stem cell COVID-19 treatment
Health & Biotech
Health & Biotech
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Cellular medicine company Mesoblast Limited (ASX:MSB) has moved onto phase two (out of three) for its COVID-19 treatment, after getting promising initial results on US patients with moderate to severe symptoms.
The company wants to find out whether its stem cell treatment — remestemcel-L — will provide a survival benefit for “moderate/severe acute respiratory distress syndrome” caused by the virus.
The treatment was initially deployed on emergency compassionate grounds for COVID-19 patients in New York.
Based on the results of those treatment rounds, Mesoblast now wants to “definitively determine” whether the use of remestemcel-L can help reduce mortality rates for COVID-19 patients who are already on ventilators, CEO Dr Silviu Itescu said.
Over 20 medical centres in the US will participate in the trial, which will complete enrolment in three to four months. Interim results may provide a guide to the market as to whether the treatment is effective, or futile.
To obtain statistical significance in accordance with FDA guidelines, Mesoblast will conduct a placebo-controlled trial on up to 300 ventilator-dependent patients in intensive care units with moderate to severe coronavirus symptoms.
Patients will receive “either two intravenous infusions of remestemcel-L within five days, or a placebo”. Measures for changes in overall mortality rates will then be taken within 30 days of the random test.
Secondary measures will then be taken to calculate the number of days patients are taken off ventilator support.
Shares in minnow health tech company Medibio (ASX:MEB) ticked higher by more than 30 per cent, after the company announced it had successfully lodged its 510k application with the US Food & Drug Administration (FDA).
The application is for the company’s MEBsleep product, which uses artificial intelligence and “neural network methodology” to identify changes in the five stages of sleep necessary to diagnose sleep disorders.
Chief medical officer Dr Archie Defillo said the application was made on time and below budget. As part of the application process, Defillo said MEBsleep results received “85 per cent overall agreement with a consensus panel of certified sleep technicians”.