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Keryx Biopharmaceuticals, Inc. Commences Phase 1 Study of KRX-0401 (Perifosine) in Recurrent Pediatric Solid Tumors at Memorial Sloan-Kettering Cancer Center
Date:7/14/2009

NEW YORK, July 14 /PRNewswire-FirstCall/ -- Keryx Biopharmaceuticals, Inc. (Nasdaq: KERX) announced today the initiation of a Phase 1 clinical study to evaluate KRX-0401 (perifosine) as a single agent treatment for recurrent solid tumors in pediatric patients. This Phase 1 study is now open for enrollment at Memorial Sloan-Kettering Cancer Center in New York City. Oren Becher, MD, Instructor, Department of Pediatrics, in coordination with Eric Holland, MD, PhD, Director of the Brain Tumor group at Memorial Sloan-Kettering Cancer Center, will act as the study's Principal Investigator. The study announced today is being fully funded by an external grant provided by a private organization.

KRX-0401 is a novel, oral, anticancer agent that modulates Akt and several other important signal transduction pathways. Keryx is currently in the process of finalizing late-stage protocols for Perifosine in the treatment of Multiple Myeloma and Metastatic Colon Cancer.

STUDY RATIONALE:

Activation of the PI3K/AKT pathway has been associated with poor prognosis, or proliferation, in several pediatric tumors such as neuroblastoma, glioblastoma, rhabdomyosarcoma, and medulloblastoma. Perifosine's inhibition of this and other pathways, as well as its ability to cross the blood-brain barrier has generated much interest in exploring its potential activity in the treatment of patients with advanced brain tumors. In vitro and in vivo data presented at AACR 2009 by investigators from the National Cancer Institute demonstrated that single agent perifosine not only induced tumor regression and delayed tumor growth, but that perifosine also improved the survival of mice bearing neuroblastoma tumors. Moreover, in a Phase 2 study conducted at Memorial Sloan-Kettering Cancer Center, perifosine induced responses and delayed disease
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