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Phase 2 Data Presented at the 52nd Annual Meeting of the American Society of Hematology Demonstrates Promising Efficacy of KRX-0401 (Perifosine) in the Treatment of Advanced Leukemia, Lymphoma and Multiple Myeloma
Date:12/6/2010

hieved a partial response with a median response duration of 9 months.  An additional 6 patients receiving the combination (40%) achieved stable disease.  The combination was well tolerated with no unexpected safety events.

The investigators concluded that perifosine in combination with sorafenib has significant anti-lymphoma activity in relapsed/refractory HL, and that perifosine as a single agent induced prolonged responses in high-risk, heavily pretreated CLL patients.

Abstract # 1842:  "Pre-Clinical and Interim Results of a Phase II Trial of Perifosine In Patients with Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL)"Study Background:  In this Phase 2 study, 12 patients with advanced CLL began treatment with single agent perifosine at 50 mg BID. 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.

Results:  1 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).  Perifosine was well tolerated with minimal dose modifications.

Abstract #3064: "Final Phase I Results of Perifosine In Combination with Lenalidomide and Dexamethasone In Patients with Relapsed or Refractory Multiple Myeloma (MM)"Additionally, the final dataset from the Phase 1 study of perifosine + lenalidomide (Revlimid®) + dexamethasone was also presented during the ASH meeting.  The final data showed a 73% objective response rate (minimal response or better) with a 50% PR or better, a median Progression-Free Survival of 10.8 months, and a median duration for Overall Survival of 30.6 months.  The myeloma investigators concluded that perifosine in combination with lenalidomide + dexamethasone was well tolerated even at the highest doses used, and demonstrated encouraging clini
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SOURCE Keryx Biopharmaceuticals, Inc.
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