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Melbourne-based regenerative medicine company Mesoblast (ASX: MSB) has released positive results for the treatment of chronic lung disease, reinforcing management's hopes around a separate trial with severe COVID-19 patients.
A Phase 2 trial in the US involved intravenous doses of stem cell product remestemcel-L, randomised with placebos, in 60 patients suffering from chronic obstructive pulmonary disease (COPD).
Significant health improvements were seen for patients with elevated levels of the inflammatory biomarker C-reactive protein (CRP) - a factor that tends to indicate a higher chance of hospitalisation or death.
High CRP rates are also seen in acute respiratory distress syndrome (ARDS), the most common life-threatening complication from COVID-19.
The peer reviewed results were released in a virtual presentation to the 2020 International Society for Cell & Gene Therapy (ISCT) annual meeting held May 28-29, 2020.
Key findings were:
- The greater the degree of inflammation, as measured by elevated CRP levels, the greater the signal of efficacy of remestemcel-L treatment in improving moderate to severe lung disease;
- Significant improvements were observed in each of the pre-specified endpoints tested, forced expiratory volume, forced vital capacity, and the distance walked in the six-minute walk test (all p <0.01), with maximal effects on all parameters seen at four months;
- In patients with the highest level of CRP (>4mg/L), those who received remestemcel-L were able to walk 55 meters further than placebo-treated patients in the six-minute walk test at four months (p=0.004). The six-minute walk test is a major independent predictor of mortality in COPD; and
- The dose administered was well tolerated with no infusion-related toxicity and no identified safety concerns.
Mesoblast chief medical officer Dr Fred Grossman says the correlation between the highest CRP levels and the greatest degree of response to remestemcel-L suggest the product's immunomodulatory effects may be triggered by inflammation.
"Since recurrent hospitalisation rates and mortality in COPD are associated with both high levels of CRP and progressive decline in the sixminute walk test, these results suggest that remestemcel-L could provide longer-term benefits for COPD patients with high levels of inflammation," says Grossman.
"They also provide a compelling rationale for the evaluation of remestemcel-L in the current United States Phase 3 randomized controlled trial of 300 patients with moderate to severe COVID-19 ARDS."
Updated at 11:38am AEST on 1 June 2020.
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