Keryx starts Ph II study of KRX-0401 in MM

New York, USA-based Keryx Biopharmaceuticals has announced the initiation of a corporate-sponsored clinical program to evaluate KRX-0401 (perifosine) as a treatment for multiple myeloma. This follows positive preclinical data presented last month at the annual meeting of the American Society of Hematology, where perifosine was shown to be active against human MM cell lines and freshly-isolated plasma cells from the bone marrow of patients with the disease, including those cells which were resistant to dexamethasone and doxorubicin.

Perifosine was shown to modulate a number of key cellular functions involved in the replication and death of MM cells, and, as in other cell lines, it was shown to be a potent Akt inhibitor. Perifosine was active in vitro and in vivo when used alone, and it appeared to be synergistic when combined with either bortezomib (Velcade) or dexamethasone.

This is a multicenter study led by Paul Richardson, clinical director of the Jerome Lipper Myeloma Center at the Dana-Farber Cancer Institute in Boston. In this Phase II study, subjects with relapsed or relapsed/refractory MM will be treated with KRX-0401 (150mg oral daily dose) to assess the single-agent activity of KRX-0401 in this patient population.