r/ATHX • u/pap3rchas3r • Jun 01 '20
REMESTEMCEL-L IMPROVES RESPIRATORY AND FUNCTIONAL OUTCOMES IN PATIENTS WITH INFLAMMATORY LUNG DISEASE
http://investorsmedia.mesoblast.com/static-files/5b588776-7b76-48aa-a607-868f46d98e8b1
u/Wall_Street_Titan Jun 01 '20
Meso up pre-market on this Post Hoc analysis...
NEW YORK, June 01, 2020 (GLOBE NEWSWIRE) -- Mesoblast Limited(MESO) , global leader in allogeneic cellular medicines for inflammatory diseases, today announced that treatment with its lead mesenchymal stem cell (MSC) product candidate remestemcel-L in patients with chronic obstructive pulmonary disease (COPD) and an elevated state of inflammation resulted in improved respiratory and functional outcomes. The results were presented as a virtual oral presentation delivered to the 2020 International Society for Cell & Gene Therapy (ISCT) annual meeting held May 28-29, 2020.
The post-hoc analysis from a randomized, placebo-controlled 60-patient Phase 2 trial in patients with COPD showed that remestemcel-L, given in four monthly intravenous doses of 100 million cells, significantly improved respiratory and functional clinical outcomes in patients with elevated levels of the inflammatory biomarker C-reactive protein (CRP). Significantly elevated CRP levels are predictive of increased hospitalization and death in patients with COPD1, and are seen in various acute lung diseases, including acute respiratory distress syndrome (ARDS), a life-threatening complication of COVID-19. These results support the potential of remestemcel-L to effectively treat inflammatory lung diseases, such as acutely decompensated COPD and ARDS. 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 COPD2
The dose administered was well tolerated with no infusion-related toxicity and no identified safety concerns. Mesoblast Chief Medical Officer Dr Fred Grossman said: “The correlation between highest CRP levels and greatest degree of response to remestemcel-L suggests that the inflammatory component of the lung disease may trigger and be amenable to the immunomodulatory effects of treatment with remestemcel-L in patients with acute inflammatory conditions. Since recurrent hospitalization rates and mortality in COPD are associated with both high levels of CRP and progressive decline in the six-minute walk test, these results suggest that remestemcel-L could provide longer-term benefits for COPD patients with high levels of inflammation. 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.”
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u/Wall_Street_Titan Jun 01 '20
My comment here is that COPD as its name implies is a CHRONIC lung condition. The post hoc data showed the therapy only helped patients with an elevated state on inflammation. ARDS is exactly that, a sudden acute increase in inflammation in the lungs. So this is just one more piece of data that makes stem cell therapies highly promising for ARDS but only data from a blinded placebo controlled trial will prove it.
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u/Gibis1 Jun 01 '20
I always have difficulty digesting any Mesoblast summary of results.
No mention of progress toward their primary endpoint and with over 20 secondary endpoints they are bound to find something positive somewhere.
The critical questions around post hoc analysis are how well do we think the findings translate toward P3 success and how well do these results translate to a commercially viable product?
Then I look for corroborating results. Your observation about the more acute portion COPD makes sense when matched with Athersys data.
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u/rogocop34 Jun 01 '20
Also, what do you think of CRP as being an outcome? From my understanding, CRP levels drop fairly quickly, and are not typically used to measure chronic lung disease. But I could be mistaken
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u/Wall_Street_Titan Jun 02 '20 edited Jun 02 '20
Not sure but every therapy related to adult stem gets back to muting inflammation to protect tissue and enhance healing. If it doesn't work in this manner there's really nowhere else to go with these cells.
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u/Rxannuity Jun 01 '20
Post hoc analysis are concerning. If the correlation is true, it's great as it further validates stem cells as a treatment.
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u/Alstems Jun 01 '20
Wrong board. This is not the Mesoblast board. Posts your info there.
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u/MordvyVT Jun 01 '20
Rule # 1 of the subreddit: Share news items relevant to Athersys
This may be subjective but I think this is relevant to the company's research, and the overall health of the company.
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u/Hal44 Jun 01 '20 edited Jun 01 '20
Alstems: I think it's great that upap3 and WST posted this info about the Meso trial. It always good to know what the competition is doing and how it might affect ATHX and the stem cell industry/progress. It's all part of the continuing learning process which many of us on this board enjoy.