Keryx Biopharmaceuticals Presents Encouraging Preclinical Data at Annual Meeting of the American Association of Cancer Research

Data Selected for Presentation Highlights Anti-Tumor effects of KRX-0401 (Perifosine)

NEW YORK, April 21, 2009 /PRNewswire-FirstCall/ -- Keryx Biopharmaceuticals, Inc. today announced multiple presentations of preclinical data highlighting the anti-tumor effects of KRX-0401 (perifosine), the company's lead anti-cancer compound, at the American Association of Cancer Research (AACR) Annual Meeting, being held in Denver, Colorado.

Abstracts selected for presentation today, Tuesday, April 21, 2009, are as follows:

Abstract 3205:

Perifosine, as a single agent, inhibits neuroblastoma tumor cell growth in in vitro and in vivo preclinical models.

Author(s): Zhijie Li, Fei Tan, Jenna Tong, Amy McKee, Carol Thiele. National Cancer Inst., Bethesda, MD

Time/location: 8:00 AM - 12:00 PM, Hall B-F, Poster Section 10, # 13

Abstract Summary: In vitro studies in neuroblastoma cell lines indicate that perifosine treatment induced inhibition of Akt phosphorylation, and decreases of cell survival. In vivo studies of perifosine treatment led to significant increases in neuroblastoma tumor bearing mouse survival. In summary, Investigators conclude that the data indicates that as a single agent, perifosine targets activation of Akt in neuroblastoma cells and xenografts, and significantly inhibits tumor growth.

Abstract 4794:

Targeting breast cancer stem cells through inhibition of PI3-K/Akt/B-catenin signaling

Author(s): Korkaya Hasan, Amanda K. Paulson, Max S. Wicha. , MI

Time/location: 3:10 - 3:25 PM, Room 205-207, Colorado Convention Ctr.

Session Title: Cancer Stem Cell Approaches for Identification and Targeting

Abstract Summary: According to Investigators, the data suggests that the PI3-K/Akt/ B-catenin pathway plays an important role in mammary stem cell self-renewal and that targeting of cancer stem cells through inhibition of this signaling pathway represents a rational therapeutic strategy.

Abstract 4576:

Potent antitumor effects of nab-rapamycin (ABI-009) in combination with kinase inhibitors Erlotinib and Perifosine

Author(s): Neil Desai, Osmond D'Cruz, Vuong Trieu. Abraxis BioScience, LLC., Los Angeles, CA

Time/location: 1:00 PM - 5:00 PM, Hall B-F, Poster Section 33, # 9

Abstract Summary: According to Investigators, this study confirmed results by Cirstea et al. that dual inhibition of the Akt pathway by rapamycin (ABI-009) and Perifosine induces synergistic anti-tumor activity in multiple myeloma (AACR Annual Meeting 2008, #4181). The synergy of these combinations confirms Investigators' hypothesis that rapamycin is active only on mTORC1 and inhibition of mTORC2 by either Erlotinib or Perifosine is necessary to achieve complete shutdown of mTOR signaling pathway.

The following abstract was presented yesterday:

Abstract 2822:

Evidence implicating Bim activation/induction in potentiation of PI3K/Akt inhibitor-mediated apoptosis in human leukemia cells

Author(s): Mohamed Rahmani, Anh Anderson, Joseph Reza Habibi, Timothy Ryan Crabtree, Hisashi Harada, Paul Dent, Steven Grant. VCU Massey Cancer Ctr., Richmond, VA

Abstract Summary: Investigators conclude that findings from this study suggest that Bim activation plays a key role in potentiating the antineoplastic activity of PI3K/Akt inhibitors in human leukemia cells, and raise the possibility that this phenomenon may contribute to synergistic interactions between PI3K/Akt and MEK1/2 inhibitors in such cells.

All abstracts can be viewed at . A copy of the posters presented at AACR may be obtained by contacting the Company.

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. We are developing Zerenex(TM) (ferric citrate), an oral, iron-based compound that has the capacity to bind to phosphate and form non-absorbable complexes. Zerenex is currently in Phase 2 clinical development for the treatment of hyperphosphatemia (elevated phosphate levels) in patients with end-stage renal disease, or ESRD. We are 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 is also engaged in business development activities that include evaluating compounds and companies for in-licensing or acquisition, as well as seeking strategic relationships for our product candidates and for our company. 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 http://www.keryx.com. The information in our website and in the American Society of Hematology'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
E-mail: lfischer@keryx.com

CONTACT: Lauren Fischer, Director - Investor Relations, KeryxBiopharmaceuticals, Inc., +1-212-531-5965, lfischer@keryx.com

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

Ticker Symbol: (NASDAQ-NMS:KERX)

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Posted: April 2009

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