Positive Results of Bone Marrow Regeneration Trial, Mesoblast (ASX: MSB; ADR: MBLTY)
MSB’s positive results from its bone marrow transplant clinical trial conducted at the University of Texas MD Anderson Cancer Center resulted in a formal meeting being scheduled with the US FDA to discuss a proposed Phase 3 clinical trial program.
For this Phase 3 program, the patented allogeneic, or “off-the-shelf,” Mesenchymal Precursor Cells (MPCs) will be used under a US FDA Orphan Drug Designation to expand haematopoietic stem and progenitor cell numbers in patients with haematologic malignancies.
In the first 25 patients transplanted with MPC-expanded haematopoietic progenitors from cord blood, 80% successfully achieved the key composite endpoint at 100 days of survival with sustained engraftment of both neutrophils and platelets. This is significantly higher than the rate of 38% for this composite endpoint achieved after transplantation with non-expanded cord blood in the US registry of 300 patients collected by the Center for International Blood and Marrow Transplant Research. To date, only 4 patients (16%) receiving expanded cord blood have developed severe graft-versus-host disease.
Mesoblast’s objective is to develop a therapy that results in effective bone marrow reconstitution without the potentially life-threatening complication of graft-versus-host disease which occurs in as many as 60% of patients who receive bone marrow transplants from unrelated adult donors.
