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Mesoblast Receives FDA Clearance For Phase 3 Bone Marrow Transplant Trial

MELBOURNE, Australia, July 7, 2011 /PRNewswire/ --

Key points:

  • Mesoblast's first Phase 3 trial submission cleared by United States Food and Drug Administration (FDA)
  • Rapid clearance (within 30 days) further validation of Mesoblast's clinical, regulatory, and manufacturing capabilities
  • Mesoblast's proprietary adult stem cells expand hematopoietic precursor cells in umbilical cord blood 40-fold, enabling rapid bone marrow reconstitution with lowered risk of life-threatening Graft Versus Host Disease (GVHD)
  • Mesoblast's novel clinical approach could make the use of bone marrow transplantation available to all those in need of the procedure but who currently cannot find a donor, without the need for full matching
  • Commercial opportunity based on potential to increase the total number of unrelated donor transplants performed globally by three- to four-fold
  • This product may be the first of Mesoblast's revenue generating biologic therapies in both the US and Europe

Global regenerative medicine company Mesoblast Limited (ASX:MSB; OTC ADR: MBLTY) today announced that it has received clearance from the United States Food and Drug Administration (FDA) to begin a Phase 3 clinical trial for bone marrow regeneration in patients with blood cancers. FDA clearance was obtained within the 30-day minimum time period after Mesoblast filed its Phase 3 Investigational New Drug (IND) submission.

The Phase 3 trial will aim to reproduce the positive pilot trial results seen at the University of Texas MD Anderson Cancer, where accelerated neutrophil and platelet recoveries, together with excellent 100-day patient survival and low GVHD rates, occurred in patients receiving partially mismatched hematopoietic cells from umbilical cord blood expanded by Mesoblast's proprietary allogeneic or 'off-the-shelf' mesenchymal precursor cells (MPCs).

Mesoblast's off-the-shelf MPCs are being developed under an Orphan Drug Designation granted for the condition of insufficient hematopoietic stem cell production in patients with hematologic malignancies who have failed treatment with conventional chemotherapy. Such patients are in need of bone marrow transplantation using hematopoietic stem cells that are of either autologous (patient's own) or allogeneic (unrelated donor, e.g. blood from other adults or umbilical cord) origin. Mesoblast's MPCs may potentially be used for expansion of both autologous and allogeneic hematopoietic stem cells for subsequent transplantation.

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