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Keryx Biopharmaceuticals Announces Poster Presentations Highlighting Clinical Activity of KRX-0401 (Perifosine) at the Upcoming Annual Meeting of the American Society of Clinical Oncology

Results Will be Reported from Phase 2 Studies Evaluating KRX-0401 in Advanced Renal Cell Carcinoma, Colorectal Cancer and Gastrointestinal Stromal Tumors (GIST)

NEW YORK, May 18 /PRNewswire-FirstCall/ -- Keryx Biopharmaceuticals, Inc. (Nasdaq: KERX) today announced that four abstracts on KRX-0401 (Perifosine), the Company's Akt-inhibitor for cancer, were accepted for presentation during poster sessions taking place at the 45th Annual Meeting of the American Society of Clinical Oncology (ASCO), to be held in Orlando, Florida from May 29 to June 2.

All of the clinical data to be presented demonstrates the potential clinical efficacy of KRX-0401, both as a single agent and in combination with other approved agents, in the treatment of patients with advanced renal cell carcinoma, colorectal cancer and GIST.

Abstracts selected for presentation are as follows:

Renal Cell Carcinoma (RCC)

Friday, May 29th, 2009:

#5034: Phase II study of perifosine in metastatic renal cell carcinoma (RCC) progressing after prior therapy (Rx) with a VEGF receptor inhibitor.

Lead Author: Nicholas Vogelzang, MD

Poster Discussion: 5:00pm-6:00pm (Level 2, West Hall F5)

Sunday, May 31st, 2009:

#5101: A phase II trial of perifosine in patients with advanced renal cell carcinoma (RCC) who have failed tyrosine kinase inhibitors (TKI).

Lead Author: Daniel Cho, MD

Poster Session: 2:00pm - 6:00pm (Level 2, West Hall C)

Colorectal Cancer

Sunday, May 31st, 2009:

#4081: Randomized phase II study of perifosine in combination with capecitabine versus capecitabine alone in patients with second- or third-line metastatic colon cancer.

Lead Author: Sasha Vukelja, MD

Poster Session: 8:00am - 12:00pm (Level 2, West Hall C)

Gastrointestinal Stromal Tumor (GIST)

Sunday, May 31st, 2009:

#10563: A randomized phase II study of perifosine (P) plus imatinib for patients with imatinib-resistant gastrointestinal stromal tumor (GIST).

Lead Author: Anthony Conley, MD

Poster Session: 2:00pm - 6:00pm (Level 2, West Hall C)

Copies of these abstracts are currently available and can be viewed on-line through the ASCO website:

About Keryx Biopharmaceuticals, Inc.

Keryx Biopharmaceuticals is focused on the acquisition, development and commercialization of medically important, novel pharmaceutical products for the treatment of life-threatening diseases, including renal disease and cancer. Keryx is developing Zerenex(TM)(ferric citrate), an oral, iron-based compound that has the capacity to bind to phosphate and form non-absorbable complexes. Zerenex has recently completed a Phase 2 clinical program as a treatment for hyperphosphatemia (elevated phosphate levels) in patients with end-stage renal disease. The Company is also developing KRX-0401 (perifosine), a novel, potentially first-in-class, oral anti-cancer agent that modulates Akt, a protein in the body associated with tumor survival and growth. KRX-0401 also modulates a number of other key signal transduction pathways, including the JNK and MAPK pathways, which are pathways associated with programmed cell death, cell growth, cell differentiation and cell survival. KRX-0401 is currently in Phase 2 clinical development for multiple tumor types. The Company also actively engages in business development activities that include seeking strategic relationships for its product candidates and for the Company, as well as evaluating compounds and companies for in-licensing or acquisition. Keryx is headquartered in New York City.

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 The information in our website and in the American Society of Clinical Oncology's website is not incorporated by reference into this press release and is included as an inactive textual reference only.

    KERYX CONTACT: Lauren Fischer Director
                       Investor Relations
                       Keryx Biopharmaceuticals, Inc.
                       Tel: 212.531.5965

SOURCE Keryx Biopharmaceuticals, Inc.
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