Keryx Biopharmaceuticals, Inc. Announces Positive Preliminary Phase 2 Data on KRX-0401 in Patients with Chemo-Insensitive Ra...(ommenting on the data Dr. Craig Henderso...),Health

Date:11/5/2007

ommenting on the data, Dr. Craig Henderson, President of Keryx Biopharmaceuticals stated, "We continue to remain encouraged by the demonstrated clinical activity of perifosine in these rare but unresponsive sarcomas. We are excited to be working with the team of SARC investigators on this important clinical study and look forward to completing accrual to all study arms in 2008.

In prior studies, KRX-0401 (perifosine) has been shown to be quite active in the treatment of soft tissue sarcoma (ASCO 2007). Responding patients experienced very little toxicity and the duration of responses observed varied from 6 months to more than 18 months. Several types of sarcomas that responded to perifosine in prior trials are particular interesting because they are generally thought to be unresponsive to chemotherapy and no treatment has been approved for them by the FDA. In this ongoing study, the single agent activity of perifosine is being evaluated in patients with chondrosarcoma, alveolar soft part sarcomas and extra-skeletal myxoid chondrosarcomas. Patients are being treated with KRX-0401 (100 mg oral daily) until disease progression. Each of the three sarcoma histology arms has met response criteria during the early phases of the study to continue enrollment up to 37 patients. In these studies, partial responses occurred in patients with sarcoma subtypes that have been traditionally unresponsive to conventional therapy.

This Phase II study was initiated in December 2006 and is being conducted by the Sarcoma Alliance for Research through Collaboration (SARC) multi-center network, which includes nationally recognized sarcoma centers and investigators throughout the United States. Dr. Dejka M. Araujo, Assistant Professor in the Department of Sarcoma at MD Anderson Cancer Center in Houston, Texas is acting as Principal Investigator for the study.

KRX-0401 (perifosine) is in-licensed by Keryx from Aeterna Zentaris, Inc. (Nasdaq:

SOURCE Keryx Biopharmaceuticals, Inc. Copyright©2007 PR Newswire. All rights reserved

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