Keryx Biopharmaceuticals commences Phase 2 clinical study evaluating KRX-0401 for Chronic Lymphocytic Leukemia

Keryx Biopharmaceuticals, Inc. (Nasdaq: KERX) announced today the initiation of a Phase 2 clinical study to evaluate KRX-0401 (perifosine) as a single agent treatment for relapsed or refractory Chronic Lymphocytic Leukemia (CLL) and Small Lymphocytic Lymphoma (SLL). This Phase 2 study was designed by Daphne Friedman, MD, Instructor and Principal Investigator, in coordination with J. Brice Weinberg, Professor, and Mark Lanasa, Assistant Professor, Divisions of Medical Oncology and Hematology, Duke University Medical Center, and is currently open for enrollment at Duke University. This study is being externally funded.

KRX-0401 (perifosine) is a novel, potentially first-in-class, oral anti-cancer agent that inhibits the phosphoinositide 3-kinase (PI3K)/Akt pathway and several other key signal transduction pathways in both hematologic and solid tumor cancers. Keryx is preparing to initiate a Phase 3 trial by year-end, under Special Protocol Assessment (SPA), for patients with advanced multiple myeloma.

Ron Bentsur, Chief Executive Officer of Keryx Biopharmaceuticals, commented, "We're very excited to explore the potential of perifosine in this advanced CLL/SLL setting, based on the pre-clinical work completed by Dr. Weinberg." Mr. Bentsur continued, "We are extremely grateful to the Duke Comprehensive Cancer Center for conducting this study, and we look forward to working with Drs. Friedman, Weinberg, Lanasa and their team of renowned oncologists on this Phase 2 study."