Clinical Trials Resource Center

White Cell Disorders

June 9, 2008

Keryx issued positive interim results from a phase II trial of KRX-0401 for the treatment of relapsed/refractory Waldenstroms macroglobulinemia (WM). This study enrolled 37 subjects, most of who had been previously treated with at least one course of therapy on rituximab. The subjects received 150 mg of perifosine daily in a 28 day cycle for at least six cycles. Partial response, defined as a 50 percent reduction in Immunoglobulin M, was observed in 5% of the subjects and minimal response, defined as a 25 percent reduction in Immunoglobulin M, was observed in 28% of the subjects. This resulted in an overall response rate of 33%. An additional 61% of the subjects reached stable disease. Treatment was well tolerated. The median time to progression has not been reached. Eleven subjects are currently receiving treatment.

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