Mesoblast’s shares were smashed when it opened trading on the ASX on Tuesday, falling more than 10 percent after the stem cell therapy group missed the primary endpoint in a study of their heart treatment, Revascor.
Prior to market opening, Mesoblast stated that its Phase 3 study of 537 patients with Revascor mesenchymal progenitor cells for the treatment of chronic heart failure had not met its primary endpoint but had reduced cardiac death.
Mesoblast derives stem cells from the bone marrow and uses mesenchymal adult stem cells to support the body’s repair and regeneration process.
Mesoblast stem cells come from the bone marrow. It uses mesenchymal adult stem cells to aid the body’s repair and regeneration process from disease or injury by releasing proteins and other cell signaling molecules that in turn reduce inflammation and begin repair.
The company did not provide specific patient count data for the primary endpoint « Reduction of recurrent non-fatal decompensated heart failure events ». .
« Despite a significant reduction in the default endpoint of cardiac death, there was no reduction in recurrent non-fatal decompensated heart failure events, which were the primary endpoint of the study, » Mesoblast said in a statement.
« This suggests that [Revascor] reduces mortality through mechanisms different from existing drugs that reduce hospitalization rates but do not significantly affect cardiac mortality. «
Dr. Fred Grossman, Mesoblast’s chief medical officer, said he expected the mortality benefit seen in the Phase 3 trial would support a potential avenue for approval of Revascor or Rexlemestrocel-L in patients with advanced chronic heart failure.
« We plan to meet and discuss possible avenues for approval based on mortality reduction with the US Food and Drug Administration, » he said.
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Mesoblast, ASX: MSB, ASX, Heart Failure, Cell Therapy, Stock Price, Stocks, Myocardial Infarction
World News – AU – Mesoblast stocks smashed in Revascor study
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