Phase 2 study of KRX-0401 (perifosine) for the treatment of chronic lymphocytic leukemia (CLL) and Hodgkin's lymphoma (HL)

Keryx Biopharmaceuticals announced results from its two Phase 2 studies of KRX-0401 (perifosine) for the treatment of advanced chronic lymphocytic leukemia (CLL) and in combination with sorafenib in the treatment of relapsed/refractory Hodgkin's lymphoma (HL).  In the first study, 26 patients were enrolled with advanced lymphoma (6 NHL, 4 CLL, 1 Waldenstroms and 15 Hodgkin's lymphoma).  73% of patients were previously refractory to their prior therapy, with 85% of patients having had 4 or more prior therapies. Perifosine (50mg twice daily) was started as a single agent for 28 days. After 28 days, patients achieving partial response (PR) or better were continued on single agent perifosine.  Patients achieving less than a PR were given the combination of perifosine (50 mg twice daily) plus Nexavar (sorafenib, from Bayer and Onyx) at 400mg twice daily.  All of the 4 CLL patients in the study achieved a partial response on single-agent perifosine within one month of treatment and remained on perifosine single agent.  Response durations for each of the 4 patients were 4, 8, 9+ and 12 months.  The remaining 22 patients were administered the combination with sorafenib, where 5 of the 15 (33%) Hodgkin's lymphoma patients achieved a partial response with a median response duration of 9 months.  An additional 6 patients receiving the combination (40%) achieved stable disease.  

In the second study, 12 patients with advanced CLL began treatment with single agent perifosine at 50mg twice daily. Patients on study were heavily pre-treated having had a median of 4 prior lines of therapy with 75% of patients classified as Rai stage IV. One patient achieved a partial response (5 months on treatment) and 5 additional patients achieved stable disease (median duration of 4.25 months), for an overall 50% clinical benefit rate (PR + SD).

KRX-0401 (perifosine) is an oral anti-cancer agent that inhibits Akt activation in the phosphoinositide 3-kinase (PI3K) pathway. It also affects a number of other key signal transduction pathways, including the JNK pathway, all of which are pathways associated with programmed cell death, cell growth, cell differentiation and cell survival.

For more information call (212) 531-5965 or visit www.keryx.com.