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Genzyme files plerixafor in the EU and the US
19 Jun 2008
Genzyme has filed for approval of its chemokine inhibitor plerixafor (Mobozil) in both the EU and US markets. Plerixafor is a small molecule which binds to the chemokine 4 receptor and is intended to enhance stem cell mobilization for collection and subsequent re-implantation of haematopoietic stem cells in patients undergoing this procedure as a result of lymphoma and multiple myeloma.
Currently, these disorders are treated with high-dose chemotherapy which has the effect of destroying bone marrow, where haematopoietic stem cells are primarily found. To counter this, patients receive an autologous transplant of stem cells following chemotherapy to replenish the cell populations and maintain healthy blood composition. In order to be collected, stem cells must be mobilized into the blood, a lengthy process which some patients are not able to complete, meaning a transplant is not possible.
Genzyme conducted two Phase III trials, each in around 300 patients with lymphoma or myeloma, which both showed a significant increase in the number of patients that achieved the target threshold for stem cell collection as well as the number undergoing a successful transplantation. Plerixafor is already available in Europe and the US under compassionate use programmes and formal launch is expected in 2009.