FDAnews
www.fdanews.com/articles/90309-retronectin-to-be-used-in-australia-for-trials-of-multiple-myeloma-therapy

RETRONECTIN TO BE USED IN AUSTRALIA FOR TRIALS OF MULTIPLE MYELOMA THERAPY

December 27, 2006

Takara Bio has entered into a license and material transfer agreement with the Peter MacCallum Cancer Centre in Melbourne, Australia to supply Takara Bio's RetroNectin for use in a Phase I clinical trial of multiple myeloma (MM). Six patients are expected to be enrolled in this Phase I trial.

In the Peter MacCallum Cancer Centre protocol, T cells collected from MM patients are retrovirally transduced in vitro utilizing the RetroNectin method with a gene encoding a chimeric receptor that specifically recognizes the oligosaccharide antigen, Lewis-Y, expressed on malignant MM cells.

Following expansion of transduced T cells in the laboratory; MM patients will be infused with these modified T cells. The gene-transduced T cells express the Lewis-Y-specific chimeric receptor, which recognizes the Lewis-Y antigen on malignant MM cells, inducing the T cells to specifically attack the malignant cells. Based on this concept, the principal investigator has shown that the growth in mice of human ovarian tumor cells expressing Lewis-Y antigen is significantly inhibited in 89 percent of mice treated with genetically-modified anti-Lewis-Y-specific T cells.

This is the 41st clinical trial in which the RetroNectin method has been used, and is the first time the RetroNectin method has been used a clinical trial conducted outside Japan, Europe or the U.S. Currently, ex vivo gene therapy is expanding throughout the world as an effective treatment method for several incurable diseases.