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Keryx Biopharmaceuticals Reports Single Agent Phase 2 Data of KRX-0401 (Perifosine) Further Demonstrating KRX-0401's Activity in the Treatment of Advanced Metastatic Renal Cell Cancer
Date:5/29/2009

KRX-0401 Demonstrates Impressive Single Agent Efficacy in Patients who Progressed after Failing Treatment Either with a VEGF Receptor Inhibitor or after Treatment with both a VEGF Receptor Inhibitor and an mTOR Inhibitor

NEW YORK, May 29 /PRNewswire-FirstCall/ -- Keryx Biopharmaceuticals, Inc. (Nasdaq: KERX) today announced data on the clinical activity of KRX-0401 (perifosine), the Company's Akt-inhibitor for cancer, as a treatment for advanced renal cell carcinoma. Abstract #5034, entitled, "Phase II study of perifosine in metastatic renal cell carcinoma (RCC) progressing after prior therapy (Rx) with a VEGF receptor," was presented earlier today in a poster session at the 45th Annual Meeting of the American Society of Clinical Oncology (ASCO), taking place in Orlando, Florida. Later this afternoon, the data will also be presented by Dr. Brian Rini, Associate Professor of Medicine at the Cleveland Clinic Taussig Cancer Institute, in a poster discussion during the Genitourinary Cancer session.

The study enrolled a total of 50 patients, of which 46 patients were evaluable for response. Evaluable patients were defined as those who had greater than 7 days of treatment. The primary endpoint of this study was clinical benefit, defined as response rate (RECIST), and progression-free survival (PFS) in RCC patients who failed a prior VEGF receptor inhibitor (sunitinib or sorafenib). Safety of perifosine in this patient population was evaluated as a secondary endpoint. Best response to single agent perifosine was as follows:

      Group     N       PR      SD > 12 wks    CBR*       Median PFS
                       N (%)       N (%)       N (%)       (SD or >)
     All Pts    46    5 (11%)    16 (35%)    21 (46%)      33 weeks
                                                      [95% CI (24, 
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SOURCE Keryx Biopharmaceuticals, Inc.
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