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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

progression in adult patients with advanced brain tumors.

Additionally, combination studies of perifosine with novel agents in patients with advanced brain tumors are expected to commence later this year. Such studies also to be funded by external grants.

Ron Bentsur, Chief Executive Officer of Keryx Biopharmaceuticals, commented, "We're very excited that Memorial-Sloan Kettering has taken on a leadership role in the first pediatric study of perifosine." Mr. Bentsur continued, "We are extremely grateful for the external financial support which we have received, and we look forward to working with Drs. Becher and Holland, and their team of renowned oncologists on this study."

STUDY DESIGN:

The single-center, open-label, Phase 1 study is entitled "Study of Single Agent Perifosine for Recurrent Pediatric Solid Tumors." In this study, perifosine is being evaluated as a single-agent in pediatric patients with any solid tumor that has failed standard therapy. Patients up to 18 years of age with a performance status of greater than 40% are eligible for this study. The study has been designed as a dose escalation study to determine the maximum tolerated dose (MTD) of perifosine alone in recurrent/progressive pediatric tumors. A standard 3+3 dose escalation design will be employed with 3 to 6 patients at each dose level. All patients will receive perifosine at a loading dose on the first day, followed by a maintenance dose to start on day two until progression of disease. A minimum of 4 and a maximum of 24 patients will be required to complete the study.

KRX-0401 (perifosine) is in-licensed by Keryx from Aeterna Zentaris, Inc. in the United States, Canada and Mexico.

About Recurrent Pediatric Tumors

Approximately 12,400 children and adolescents younger than 20 years of age are diagnosed with some type of cancer each year. Amon
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SOURCE Keryx Biopharmaceuticals, Inc.
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