Keryx Biopharmaceuticals’ Phase 2 Data of KRX-0401 (Perifosine) in the Treatment of Advanced Metastatic Renal Cell Cancer Selected for Oral Presentation at the Eighth International Kidney Cancer Symposium

NEW YORK, Sept. 14 /PRNewswire-FirstCall/ -- Keryx Biopharmaceuticals, Inc. today announced that Phase 2 data of KRX-0401 (perifosine), the Company's PI3K/Akt pathway inhibitor for cancer, as a single agent in the treatment of advanced metastatic renal cell cancer, has been selected for oral presentation at the Eighth International Kidney Cancer Symposium, to be held in Chicago from September 25-26, 2009.

This multi-center Phase 2 study was led by both Dr. Hutson and Dr. Nicholas Vogelzang, Chair and Medical Director of Developmental Therapeutics, Comprehensive Cancer Centers of Nevada / US Oncology Research. Drs. Hutson and Vogelzang also serve as co-chairs of the Genitourinary Committee for US Oncology Research. Data from this study was first presented by Dr. Vogelzang at the ASCO meeting in May 2009. Dr. Hutson's presentation will include updated information from the study.

About Renal Cell Carcinoma (RCC)

Of all kidney tumors, 85% are classified as renal cell carcinoma (RCC) and of all patients with RCC, 25% present with advanced disease. Advanced RCC is resistant to such standard treatments as radiation therapy and chemotherapy, and the initial treatment for most patients is surgical removal of the kidney. If the cancer is confined to the kidney, the five-year survival rate is 60 to 70 percent; but the survival rate is considerably lower after the cancer has metastasized to other parts of the body. Even with the recent approval of several biological therapies for the treatment of advanced metastatic RCC (VEGF inhibitors, sunitinib and sorafenib, and mTOR inhibitors everolimus and temsirolimus), the National Cancer Institute reports a rising incidence of RCC with incidence and mortality rates more than twice as high in men as in women. In 2009, an estimated 49,000 new cases of RCC and 11,000 deaths attributable to RCC are expected in the US.

Cautionary Statement

Some of the statements included in this press release, particularly those anticipating future clinical and business prospects for KRX-0401, may be forward-looking statements that involve a number of risks and uncertainties. For those statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Among the factors that could cause our actual results to differ materially are the following: our ability to successfully complete clinical trials for KRX-0401; our ability to meet anticipated development timelines for KRX-0401 due to recruitment, clinical trial results, manufacturing capabilities or other factors; and other risk factors identified from time to time in our reports filed with the Securities and Exchange Commission. Any forward-looking statements set forth in this press release speak only as of the date of this press release. We do not intend to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. This press release and prior releases are available at http://www.keryx.com. The information in our website is not incorporated by reference into this press release and is included as an inactive textual reference only.

SOURCE Keryx Biopharmaceuticals, Inc.

CONTACT: Lauren Fischer, Director, Investor Relations, Keryx
Biopharmaceuticals, Inc., +1-212-531-5962, lfischer@keryx.com

Web site: http://www.keryx.com/

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