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Mozibil Increases Stem Cell Count in Phase III Trials

Tuesday, July 31, 2007 07:39 AM

Genzyme reported positive results from a phase III trial of Mozobil (plerixa), a CXCR4 chemokine antagonist, as an agent for increasing the number of hematopoietic stem cells collected for stem cell transplantation procedures for the treatment of various cancers.

This randomized, double-blind, placebo-controlled trial enrolled 298 subjects undergoing a hematopoietic stem cell transplant (HSCT) for non-Hodgkin's lymphoma, in the U.S. and Canada. The trial was designed to compare the hematopoietic stem cell yield from subjects treated with Mozobil in combination with granulocyte-colony stimulating factor (G-CSF, standard of care) to subjects treated with G-CSF in combination with placebo.

The primary efficacy endpoint was achieved, with 59% of the subjects in the Mozobil arm reaching the target threshold for collection of at least 5 million CD34+cells/kg from the peripheral blood with four or fewer days of apheresis sessions, compared with 20% in the placebo arm (p<0.0001). The secondary endpoint also reached statistical significance, with nearly 87% of the subjects in the Mozobil arm minimum level of stem cells generally associated with a successful transplant (2 million CD34+cells/kg) in four or fewer days of apheresis sessions, compared to 47% in the placebo arm (p<0.0001).

Genzyme aquired the rights to Mozobil through the purchase of AnorMED in November 2006. It plans to file for U.S. and European approval for lymphoma in the first half of 2008.

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